CN102895334A - Preparation technology and production method for integrated new formulation of licorice and monkshood decoction - Google Patents
Preparation technology and production method for integrated new formulation of licorice and monkshood decoction Download PDFInfo
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- CN102895334A CN102895334A CN2011102144526A CN201110214452A CN102895334A CN 102895334 A CN102895334 A CN 102895334A CN 2011102144526 A CN2011102144526 A CN 2011102144526A CN 201110214452 A CN201110214452 A CN 201110214452A CN 102895334 A CN102895334 A CN 102895334A
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Abstract
The present invention relates to a preparation technology and a production method for an integrated new formulation of a licorice and monkshood decoction, wherein the raw materials of active ingredients comprise: 6 parts by weight of honey-fried licorice, 12 parts by weight of monkshood, 6 parts by weight of bighead atractylodes rhizome, and 12 parts by weight of cinnamon twig. The production process of the integrated new formulation of licorice and monkshood decoction comprises the following steps of: supersonic air-jet crushing, alcohol-water extraction, ultrasonic crushing extraction, water decocting concentration, supersonic spray drying, nanometer grinding, high pressure homogenization, nano particle preparation and the like. According to the invention, the advantages, such as multi-synergism, multi-target, embodied by a nano-carrier coupling technique, are focused to be taken of. After the integrated new formulation of licorice and monkshood decoction is subjected to scale production, the production cost can be greatly reduced, the quality of products is greatly improved and the targeting property and the sustained and controlled release performance of the medicament are enhanced. The internal and external administration of the integrated new formulation of licorice and monkshood decoction can be realized simultaneously, and can be respectively taken in four time slices according to midnight-noon ebb-flow and qi and blood flowing rule of a human body. The integrated new formulation of licorice and monkshood decoction can be further prepared into films and transdermal agents which are respectively stuck to different parts of a human body according to the midnight-noon ebb-flow and qi and blood flowing rule of the human body and can be directly absorbed through skin.
Description
Technical field
The present invention relates to a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology, the invention still further relates to a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof.
Background technology
Chinese medicine decocting liquid compound recipe drug effect chemical reaction is too many because of chemical constituent, temporary transient not revealed its Mysterious Veil also, but some mysterious black box drug actions are just ensconced in the Chinese medicine decocting liquid in the Chinese medicinal formulae, can not ask simply Chinese medicine westernization, the modernization of Chinese medicine most and only use monomer and effective site.The Chinese medicine water drug-decocting concentrating liquid could not be given it up! When the Chinese medicinal formulae water decocts, because prescription closes chemical environment complicated in high temperature when frying in shallow oil and the solution, the reaction such as complexation, hydrolysis, oxidation, reduction between intrinsic material may occur in solution, thereby some novel substance that did not originally have in the generation solution, these novel substances produce the drug actions such as potentiation, attenuation or modification to full side.New component forms the research of mechanism, stability and drug effect thereof in the reinforcement Chinese medicinal formulae decocting liquid, to improving Chinese medicine compound and new drug level, progressively dwindle Chinese medicine compound and new Chinese medicine and international gap, very important meaning is arranged, also increased new way and new source for the research and development new Chinese medicine simultaneously.
China's drug control relevant laws and regulations regulation changes dosage form and manages as new drug research.The backwardness of preparation level not only affects the performance of curative effect of medication, and cause the medicine added value low, directly affecting the market competition and industrial economy benefit, is to cause China's medical industry product quantity to occupy prostatitis, the world and the output value only is equivalent to the one of the main reasons of one or two transnational drugmaker.
New drug, novel form development level can embody economy and the technical strength of the medical industry of a country.China's oral formulations accounts for 2/3 of various whole body drug-delivery preparations, and accelerating development and promoting oral sustained-release preparation is the work that current urgent need will be done.
The Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction prescription derives from treatise on Febrile Diseases.The party's ingredients is 2 liang in Radix Glycyrrhizae (processing), 2 pieces of Radix Aconiti Lateralis Preparatas (big gun, peeling are broken), 2 liang of the Rhizoma Atractylodis Macrocephalaes, 4 liang of Ramulus Cinnamomi (peeling).Function: warming the muscle and tonifying middleJIAO, beneficial vital essence.Cure mainly: invasion of the body by blended pathogenic wind and dampness, acute pain in the joints, dragging pain must not bend and stretch, and near then pain is acute, sweating and shortness of breath, dysuria, aversion to wind no desire to take off clothes, or slight swelling of the body person; Wind syndrome with vertigo and heavy sensation in the head due to deficiency, bitter utmost point poor appetite.We's modern times can be used for treating rheumatic heart disease, coronary heart disease, the thoracic obstruction, arthralgia due to cold, for a long time heat do not move back, have blood in stool, health pain, pain all over the joints, slight swelling of the body person, satisfactory for result.
The side separates: the wet muscles and bones joint of invading of wind and cold, and dysfunction of both nutrient QI and defernsive QI, QI and blood is solidifying puckery, with muscles and bones severe pain tenderness, must not bend and stretch and is feature, with Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction warming YANG to expel cold, damp-clearing pain-relieving.The attached same usefulness of Fang Zhonggui, but both dispersing cold for relieving pain, but strengthening superficial resistance to stop perspiration again.Assertive evidence is that rheumatism is kept the joint, and the darker one deck of the state of an illness is difficult to speed and goes, so subtract the Radix Aconiti Lateralis Preparata consumption, is intended to jogging.The attached same usefulness of art, the spleen strengthening and damp drying then, warming YANG activating QI.Gui Gantong usefulness rouses oneself heart-yang, control lose heart, dysuria.Medicine is four flavors only, and is real in treating the good recipe of rheumatism.Each is discussed: 1. " interior platform side view ": wind is then defended wound, dampness flowing into joints, and invasion of the body by blended pathogenic wind and dampness, two evil disarrangement of meridian-QI,
So acute pain in the joints, dragging pain must not bend and stretch, and near then pain is acute.Domination of wind is failure of defensive QI to protect the body against pathogen then, sweating and shortness of breath, and the aversion to wind no desire to take off clothes is for wind is being shown also.Domination of damp pathogen then aqueous vapor is not all right, and dysuria, or slight swelling of the body are for fighting also in the dampness.So be monarch with Radix Aconiti Lateralis Preparata, dehumidifying is dispeled the wind, dispelling cold by warming the meridian; Ramulus Cinnamomi is minister, and Gu Wei dispels the wind; The Rhizoma Atractylodis Macrocephalae dries as making; Radix Glycyrrhizae is assistant, and auxiliary all medicines.The side that the dispelling wind cold removing wets also.2. " hospital examines ": invasion of the body by blended pathogenic wind and dampness, so acute pain in the joints; So the then aversion to wind of catching cold is no desire to take off clothes; Dysuria, and the dry person that defecates is heat; Modern dysuria and defecate anti-fast, then wet as can be known.The heat of Radix Aconiti Lateralis Preparata can wet by cold expelling; The suffering of Ramulus Cinnamomi can go to separate rheumatism; The Radix Glycyrrhizae spleen invigorating, then wet living; The dry spleen of the Rhizoma Atractylodis Macrocephalae, then wetting has system.The side of being also, with osmanthus, attached hot and control wet, the ground that mire still is hasty and careless, get the sun sudden and violent it, not all morning and wet going, also control wet together also.3. " gold deficient beautiful letter through two notes " Zhou Yangjun: sweating and shortness of breath, aversion to wind no desire to take off clothes, pathogenic wind attack and in, all void of the healthy energy of defending is also; Dysuria, the slight swelling of the body person, China and foreign countries are held by wet, and the change of bladder is also not all right, pacify not with sweet, art and in, osmanthus, attached uncharming? right this disease is heavier than preceding article, and in injured, how for counter deduct Radix Aconiti Lateralis Preparata that? in this rheumatism partly enters, enter that inner person is wonderful to be attacked slow, Zhong Jingzheng fears Radix Aconiti Lateralis Preparata, and property is violent and anxious at most, and the key of joint may not be opened suddenly, how could the heresy of rheumatism be held out? on foot make profuse perspiration and heresy not to the utmost you.Monarch Radix Glycyrrhizae person wants that it is slow also, and in power short, love usefulness of medicine and grow also.So this Zhong Jing preceding article is with 3 pieces of persons of Radix Aconiti Lateralis Preparata, minute 3 clothes, this ends 2 pieces of persons, just takes 5 and closes, and probably 1 is upgraded to manyly, should take 6-7 and close, and is the most meaning of agent of wish not entirely.4. " ancient prescription choosing annotate ": Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction, the prescription with ingredients even in number of two tables two li, wind is excessive in table, dampness flowing into joints, the sun excess of YIN that declines, controlling should two Gu.Victory was wet in the Rhizoma Atractylodis Macrocephalae, Radix Aconiti Lateralis Preparata turned round and look at, and Ramulus Cinnamomi, the wind-transformation of Radix Glycyrrhizae Gu table solely are preced with its person with Radix Glycyrrhizae, sick deeply joint, justice row delaying, rescue is also slowly.
Clinical practice: 1. rheumatalgia: a title of generals in ancient times makes Wu humorous, begins August 26 first year to feel such as wind to build unit, to 7 days, times down just the soldier rises, and thigh and hands are neither, and swell in the whole body with, the logical lumbar and back pain of drawing, and the heart is expired more.Taking 1 dose of this soup on the 4th to JIUYUE, sweats in the whole body, namely always suffers from knowing healing." thank and reflect the hut case " Gao Hanzhang, rheumatism, arthralgia all over, hands can not touch closely, near then bitterly very, little spontaneous sweating, little water is unfavorable.At that time early summer, return boat from the Chinese and seek medical advice, meeting its body brothers all has little swelling, and weather is quite warm, and still heavy fur coat does not take off, and pulse condition is quite large, and gas is continuous mutually.Its relatives and friends have a full house, ask it is what disease? give and saying: this rheumatism is for sick.Canal is said: more than the medicine of all dispelling wind and dampness, clothes, not only unhelpful, and anti-weightening finish.Answer and say: this exopathogen of husband's wind, when controlling from table, but the honor body surface is empty, and what dares diaphoresis; Wet evil in this again, must control from inner, and is the honor body interior deficiency you flatter me diuretic? when abiding by Zhong Jingfa place Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction.1 dose as refreshing, 3 doses of clothes, all moneys are known and are healed.2. arthralgia due to cold: alone we's treatment arthralgia due to cold 2 examples, Western medicine diagnose is the scorching secondary sciatica of chronic lumbosacral joint.Wherein 1 example has more than 10 years medical histories.All obtain healing.The author thinks, all genus rheumatism and arthritis, even without perspiration and aversion to wind, lose heart, the disease such as dysuria, with also desirable effect of we.3. rheumatic heart disease: certain woman, 45 years old.Element suffers from that rheumatic heart disease, cardiopalmus are losed heart, perspiration and aversion to wind, joint cold type of pain, localized pain, edema of lower limbs, dysuria, pale tongue with white fur, deep and stringy pulse.This is invasion of the body by blended pathogenic wind and dampness, does not with the passing of time heal, and is evil in cold transformation.Controlling warming the spleen removing dampness cold expelling to be main, and assistant is activated yang with heart tonifying.Radix Glycyrrhizae Preparata 15g, gun additioner 10g, Rhizoma Atractylodis Macrocephalae 10g, Ramulus Cinnamomi 5g, Poria 15g.Decoction.After 1 month, cardiopalmus is losed heart and is before alleviated, and the joint is pain not, and edema of lower limbs disappears, and urine is normal.
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction modern Chinese medicine novel form Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, both at home and abroad without identical or similar bibliographical information.Research and development have reached world lead level.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and patent retrieval.Utilize domestic and foreign databases to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains drawing a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano powder body that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. are prepared the nanosphere of different-grain diameter size with the different pharmaceutical carrier, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immunonanoparticles, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro is assisted etc., and then mixing is respectively charged into soft, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) use nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product has the characteristics such as targeting distributes extensively, slow controlled release properties is strong; Have no at home open report in the document, these project complex art characteristics have certain novelty and novelty.Science and technology is looked into new numbering: 200921c0704948.
Further: this dosage form preparation technology is the advantage separately of having integrated the traditional Chinese medical science, doctor trained in Western medicine, take the organic conception of theory of Chinese medical science and pay attention to collaborative idea between medicine and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs as the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer in treating, pay attention to the mass action that Chinese medicine active substance, effective site and active materials play the treatment disease.Pay attention to the assosting effect that the contained trace element of Chinese medicine plays the treatment disease.The effective ingredient of the used Chinese medicine of this Chinese medicine compound is clear and definite, and medicine effect has obtained admitting of modern medicine.Pay attention to using nano-carrier multiple techniques development modern Chinese medicine.These will promote the development of China's Chinese Medicine Industry.
Summary of the invention:
Purpose of the present invention is exactly in order to solve the above-mentioned problems in the prior art, and a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof are provided.
Purpose of the present invention is achieved through the following technical solutions:
A kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, wherein: the raw material of this integrated novel form effective ingredient and weight proportion---
6 parts of Radix Glycyrrhizae Preparatas, 12 parts of Radix Aconiti Lateralis Preparatas, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 12 parts of Ramulus Cinnamomi.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
Above-mentioned a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, wherein: medicine and carrier are prepared into the pharmaceutical carrier crude drug, crude drug can be one or more combinations in nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the microcapsule etc., and can as required one or more be mixed.Described protection domain is not only the said medicine support material medicine in the described scope, is also included within to prepare on its basis or add the curative effect that other do not affect its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.Further, above-mentioned a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, wherein: the drug carrier material that this novel form is selected, activating agent, help Emulsion, the excipient substances such as dispersant are gelatin, albumin, starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid, cyanoacrylate, the semisolid poe, triglyceride is (such as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (such as glyceryl monostearate, contains list, two, the synthetic glyceride of triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, the whale ester type waxes, erythrocyte, Montmorillonitum, in the tea powder etc. one or more.Described excipient substance is not only the said medicine adjuvant in the described scope, and other do not affect its disease of controlling to be also included within the upper interpolation in its basis, and just make the excipient substance of its better efficacy.
Further, above-mentioned a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, wherein: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active materials, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different excipient substance, pharmaceutical carrier according to indexs such as the pharmacology of traditional Chinese medical science global theory, compatibility theory and medicine, drug effect, medicine generation, toxicitys.And can mix its one or more according to the preparation needs.
Again further, above-mentioned a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, wherein: the integrated novel form end product that finally can form is: tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, unguentum, oral solution, slow releasing tablet, controlled release tablet.
A kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, it may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% Radix Glycyrrhizae Preparata, Radix Aconiti Lateralis Preparata micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol, and it is for subsequent use to get extract.
Step 3: get 60% the Rhizoma Atractylodis Macrocephalae, Ramulus Cinnamomi micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, to pulverize extraction time be 10-100 minute, and it is for subsequent use to get extract.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate is concentrated, gets Chinese medical concrete or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances by version in 2010 " preparation part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle diameter is between 10 nanometers-10 micron.
Step 8: " preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.
Step 9: in GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by version in 2010 " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.
Step 10: the end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
Above-mentioned a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof; wherein: the Chinese medicine of using in described step 1, step 2, the step 3 is pulverized and extracting method; described protection domain is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if, more economical, renewal, breaking method more advanced, more environmental protection, extracting method and technology.
Further, above-mentioned a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, wherein: the crude drug such as the dissimilar nanoparticle that employing different pharmaceutical adjuvant is prepared in the medicine monomer in the described step 6, active substance, effective site technology of preparing and the described step 7, nano-emulsion.The described protection domain of this claim is not only described technology of preparing and method, as required, be also included within add on its basis or use other better effects if, more economical, upgrade, preparation method more advanced, more environmental protection and technology.
Further, above-mentioned a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, wherein: its key point 1 is different utilization nano-carrier multiple techniques different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targetings.
Again further, above-mentioned a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, wherein: its key point 2 is to develop simultaneously by interior external administration, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Also can be prepared into membrane, transdermal agent is attached to respectively the human body different parts by the energy and blood of human body flowing law, directly absorb by skin.
The outstanding substantive distinguishing features of technical solution of the present invention and significant progressive being mainly reflected in:
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that the Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, both at home and abroad without identical or similar bibliographical information.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and Patent database searching.Utilize domestic and foreign databases to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains drawing a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano powder body that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. are prepared the nanosphere of different-grain diameter size with the different pharmaceutical carrier, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immunonanoparticles, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro is assisted etc., and then mixing is respectively charged into soft, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) use nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product has the characteristics such as targeting distributes extensively, slow controlled release properties is strong; Have no at home open report in the document, these project complex art characteristics have certain novelty and novelty.Science and technology is looked into new numbering: 200921c0704948.
Further, this dosage form preparation technology and production method thereof are to have integrated the advantage separately of the traditional Chinese medical science, doctor trained in Western medicine, take the organic conception of theory of Chinese medical science and pay attention to collaborative idea between medicine and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs as the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer in treating, pay attention to the assosting effect that Chinese medicine active substance, effective site and active materials play the treatment disease.Pay attention to the assosting effect that the contained trace element of Chinese medicine plays the treatment disease.The effective ingredient of the used Chinese medicine of this Chinese medicine compound is clear and definite, and medicine effect has obtained admitting of modern medicine.Pay attention to the different nano-carrier dosage form technologies of preparing of Chinese medicine and unite use.To adopt Chinese medicine crude drug nano-powder, monomer, effective site, effective part group, traditional Chinese drug inspissation extractum, water drug-decocting concentrating liquid, nano-medicament carrier etc. to unite use on the compatibility.These various Chinese traditional powder particle diameter major parts of filling a prescription are the granule of 50～1000 nanometers.Adopting different nano-medicament carriers to be prepared into nanoparticle, nanosphere, nanocapsule, solid ester matter nanoparticle, nano-emulsion, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro assists etc.Its particle size distribution is in 10 nanometers---between 10 microns.Then theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of pharmacology, targeting, reasonable compatibility mixes, and is respectively charged among hard capsule and the soft capsule.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into respectively the targeted systems such as RE targeted system, stomach mucosa absorption system, intestinal absorption system, colon absorption system.Compare Chinese medicine and medicine monomer, the target-oriented drug of the overall coordination therapeutical effect of this Chinese medicine compound novel form, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.Multichip carrier and multiple medicines thing monomer etc. are united use, have broken through the traditional monarch compatibility theory of the traditional Chinese medical science, for the modern Chinese medicine development provides a practical effective novel form compatibility program.To have substantial technological innovation to break through.
Purpose of the present invention, advantage and disadvantage will make an explanation by the non-limitative illustration of following preferred embodiment.These embodiment only are the prominent examples of using technical solution of the present invention, and all technical schemes of taking to be equal to replacement or equivalent transformation and forming all drop within the scope of protection of present invention.
The specific embodiment
A kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof, its special feature is: the raw material composition of making effective ingredient is by weight ratio---
6 parts of Radix Glycyrrhizae Preparatas, 12 parts of Radix Aconiti Lateralis Preparatas, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 12 parts of Ramulus Cinnamomi.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening the Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction curative effect and significantly improve prepared slices of Chinese crude drugs cell wall breaking with this; 2, with Chinese medicine extract and select suitable pharmaceutical carrier, prepare different Chemistry for Chinese Traditional Medicine monomers, effective ingredient, effective site etc., confirm and strengthen pharmacology, the efficacy of the chemical substance of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction with this; 3, prepare Chinese medical concrete, water drug-decocting concentrating liquid with the prepared slices of Chinese crude drugs, the temporary transient unpredictable drug effect of bringing with this reaction such as complexation, hydrolysis, oxidation, reduction of strengthening Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction Chinese medicine compound uniqueness also keeps and has strengthened traditional Chinese medical science organic conception, monarch concept.Above three aspects: associating compatibility uses, different according to Nano medication particle diameter and character, can reach many targeting, many collaborative, slow controlled release texts, and play useful effect to strengthening the medicine pharmacologically active, effective ingredient pharmacological action effect is significantly higher than conventional formulation.
Production method of the present invention may further comprise the steps:
At first, get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.Get 30%-90% alcohol-water solution that 60% Radix Glycyrrhizae Preparata, Radix Aconiti Lateralis Preparata micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol, and it is for subsequent use to get extract.Get 60% the Rhizoma Atractylodis Macrocephalae, Ramulus Cinnamomi micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, and it is for subsequent use to get extract.With above-mentioned gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is 50 nanometers-1000 nanometer, for subsequent use.Get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with for subsequent use.With above-mentioned gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.Adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron." preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as above-mentioned gained Chinese medical concrete or water drug-decocting concentrating liquid and above-mentioned gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.In GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can make by the related preparations standard criterion the above-mentioned end product of other type.The end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
" embodiment one "
Press the following crude drug of preceding method preparation: extractum, nanoparticle, microcapsule, nanoparticle.
Its raw material of making effective ingredient forms---
6 parts of Radix Glycyrrhizae Preparatas, 12 parts of Radix Aconiti Lateralis Preparatas, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 12 parts of Ramulus Cinnamomi.
Its manufacture process is as follows: in GMP10000 level toilet with extractum, nanoparticle, microcapsule, nanoparticle in 4: 2: 2: after 2 ratios are mixed, adopt a version " preparation part of Chinese pharmacopoeia hard capsule standard in 2010, do not add adjuvant, antiseptic, adopt full-automatic capsule filling machine fill hard capsule, make hard capsule.Carry out again several, bottle, seal, paste labeling, play the exterior and interior packings such as code, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.
" embodiment two "
Press the following crude drug of preceding method preparation: water drug-decocting concentrating liquid, nanometer liposome, nano-emulsion, microemulsion.
Its raw material of making effective ingredient forms---
6 parts of Radix Glycyrrhizae Preparatas, 12 parts of Radix Aconiti Lateralis Preparatas, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 12 parts of Ramulus Cinnamomi.
Its manufacture process is as follows: in GMP10000 level toilet with water drug-decocting concentrating liquid, nanometer liposome, nano-emulsion, microemulsion in 4: 2: 2: after 2 ratios are mixed, adopt a version " preparation part of Chinese pharmacopoeia soft capsule standard in 2010, do not add adjuvant, antiseptic, adopt full-automatic soft capsule filling machine packing soft capsule, make soft capsule.Carry out again several, bottle, seal, paste labeling, play the exterior and interior packings such as code, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.
" embodiment three "
Press the following crude drug of preceding method preparation: extractum, nanoparticle, nano-emulsion.
Its raw material of making effective ingredient forms---
6 parts of Radix Glycyrrhizae Preparatas, 12 parts of Radix Aconiti Lateralis Preparatas, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 12 parts of Ramulus Cinnamomi.
Its manufacture process is as follows: after in the GMP10000 level toilet extractum, nanoparticle, nano-emulsion being mixed in 4: 3: 3 ratios, " a preparation part of Chinese pharmacopoeia membrane standard, filmogen adopts polyvinyl alcohol, makes membrane to adopt version in 2010.Carry out again mounted box, sealing, stickup labeling, play the exterior and interior packings such as code, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.Every membrane area size is the 2-40 square centimeter, and every medicine film pasted 12-72 hour, pasted the medicine position: the positions such as neck, chest, back part, abdominal part, shank, foot bottom, Ashi point.
Can find out by above-mentioned text description: the tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction Chinese medicine compound Chinese and western medicine theory combines, and the compound compatibility of modern Chinese medicine and technology of preparing can change the pharmacokinetic parameter of medicine monomer, effective ingredient or effective part group.This has proved the scientific meaning of Chinese medicine compound compatibility from the pharmacokinetics level." very just be harmonious, negative and positive intercommunication, coordinating water and fire, precise and tiny circle melt, and greatness lies in the capacity " is that the precise and tiny circle of the integrated novel form of this medicine melts Integration Theory basis and guiding theory.Among the present invention: monomer, effective site, nanoparticle and carrier etc. be strange, be tiny, be cloudy.Traditional Chinese medical science organic conception, Chinese medical concrete, water drug-decocting concentrating liquid etc. be just, be grand, be the sun.Very just be harmonious then negative and positive intercommunication, the negative and positive intercommunication is then coordinating water and fire, is the optimum balance attitude.Doctor trained in Western medicine research is precise and tiny, and theory of Chinese medical science is that circle melts, and both very just are harmonious, and have just really embodied the organic conception of the combination of Chinese and Western medicine, and " close " is that " integration " is for holding.The tidemark that greatness lies in the capacity, the coordinating water and fire the present invention of being only asked most.This integrated novel form is by the reasonable compatibility of Chinese medicine monomer, effective site, active substance, Chinese medicine active materials, extractum, water drug-decocting concentrating liquid, prepared slices of Chinese crude drugs nano-particle etc., can produce soft, hard capsule or the dosage forms such as nanometer membrane, transdermal agent.Can develop simultaneously, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law by interior external administration.Can also do film former to nano traditional Chinese medicine, transdermal agent is attached to the human body different parts, can directly absorb by skin.
See that further the various Chinese medicine particle diameter major parts that the present invention prepares are the granule of 50～1000 nanometers.Adopt different nano-medicament carriers and technology can be prepared into nanoparticle, nanosphere, solid ester plastid, nano-emulsion, pharmacosomes, microgranule, nanoparticles, little assist etc.Its particle size distribution is in 10 nanometers---between-10 microns.Then theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of medicine pharmacology, targeting, reasonable compatibility mixes, and can be respectively charged among hard capsule and the soft capsule.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into respectively the targeted systems such as RE targeted system, stomach mucosa absorption system, intestinal absorption system, colon absorption system.Compare Chinese medicine and medicine monomer or Western medicine, the overall coordination therapeutical effect of this integrated novel form and target-oriented drug, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.For Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction modern Chinese medicine preparation and production have proposed a practical effective novel form compatibility program.To have substantial innovation and technological break-through.
Classics side resemble the Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction is the imbody of the theoretical marrow of differentiation of tcm, and the party has a wide range of applications in the different field of tcm clinical practice, goes through bimillennium and does not wane.Therefore, its full side is carried out further developmental research important in inhibiting.This just need us Emancipate the mind and seek truth from facts from Chinese medical theory, strengthen the research and development dynamics of traditional Chinese medical science ancient prescription, make these ancient prescriptions obtain more adequately and reasonably using.
Claims (10)
1. a Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof is characterized in that: the raw material of this novel form effective ingredient and weight proportion---
6 parts of Radix Glycyrrhizae Preparatas, 12 parts of Radix Aconiti Lateralis Preparatas, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 12 parts of Ramulus Cinnamomi.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology according to claim 1 and production method thereof, it is characterized in that: medicine and carrier are prepared into the pharmaceutical carrier crude drug, crude drug can be one or more combinations in nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the microcapsule etc., and can as required one or more be mixed.The described protection domain of this claim is not only the said medicine support material medicine in the described scope, is also included within to prepare on its basis or add the curative effect that other do not affect its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.
3. according to claim 1,2 described a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production methods thereof, it is characterized in that: the drug carrier material that this novel form is selected, activating agent, help Emulsion, the excipient substances such as dispersant are gelatin, albumin, starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid, cyanoacrylate, the semisolid poe, triglyceride is (such as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (such as glyceryl monostearate, contains list, two, the synthetic glyceride of triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, the whale ester type waxes, erythrocyte, Montmorillonitum, in the tea powder etc. one or more.The described protection domain of this claim is not only the said medicine adjuvant in the described scope, and other do not affect its disease of controlling to be also included within the upper interpolation in its basis, and just make the excipient substance of its better efficacy.
4. according to claim 1 and 2 or the described a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology of 3 any one and production method thereof, it is characterized in that: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active materials, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different excipient substance, pharmaceutical carrier according to indexs such as the pharmacology of traditional Chinese medical science global theory, compatibility theory and medicine, drug effect, medicine generation, toxicitys.And can mix its one or more according to the preparation needs.
5. according to claim 1 and 2 or the described a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology of 3 or 4 any one and production method thereof, it is characterized in that: the integrated novel form end product that finally can form is: tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, unguentum, oral solution, slow releasing tablet, controlled release tablet.
6. a Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology and production method thereof is characterized in that may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% Radix Glycyrrhizae Preparata, Radix Aconiti Lateralis Preparata micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol, and it is for subsequent use to get extract.
Step 3: get 60% the Rhizoma Atractylodis Macrocephalae, Ramulus Cinnamomi micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, and it is for subsequent use to get extract.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate is concentrated, gets extractum or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle diameter is between 10 nanometers-10 micron.
Step 8: " preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.
Step 9: in GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by version in 2010 " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.
Step 10: the end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
7. a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology according to claim 6 and production method thereof; it is characterized in that: the pulverizing of using in described step 1, step 2, the step 3 and extracting method; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if, more economical, renewal, breaking method more advanced, more environmental protection, extracting method and technology.
8. a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology according to claim 7 and production method thereof; it is characterized in that: the medicine monomer in the described step 6; active substance; the dissimilar nanoparticle that adopts the different pharmaceutical adjuvant to be prepared in effective site technology of preparing and the described step 7; the crude drug such as nano-emulsion; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if; more economical; upgrade; more advanced; the more preparation method of environmental protection and technology.
9. a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology according to claim 8 and production method thereof, it is characterized in that: its key point 1 is different utilization nano-carrier multiple techniques different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targetings.
10. a kind of Radix Glycyrrhizae et Radix Aconiti Lateralis Preparata Decoction dosage form preparation technology according to claim 9 and production method thereof is characterized in that: its key point 2 be can in external administration develop simultaneously, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Also can be prepared into membrane, transdermal agent is attached to respectively the human body different parts by the energy and blood of human body flowing law, directly absorb by skin.
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