CN102138915A - Oral medicine preparation and preparation method thereof - Google Patents
Oral medicine preparation and preparation method thereof Download PDFInfo
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- CN102138915A CN102138915A CN 201110075956 CN201110075956A CN102138915A CN 102138915 A CN102138915 A CN 102138915A CN 201110075956 CN201110075956 CN 201110075956 CN 201110075956 A CN201110075956 A CN 201110075956A CN 102138915 A CN102138915 A CN 102138915A
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Abstract
The invention discloses an oral medicine preparation and a preparation method thereof. The oral medicine preparation is a membrane preparation prepared from pharmaceutically effective amount of active medicines and auxiliary materials which are uniformly dispersed in water on a coating machine through a solution coating method, wherein the auxiliary materials comprise at least one water-soluble high polymer, an ion exchange resin and other adjuvant. Compared with the prior art, the prepared orally instant membrane preparation can be quickly dissolved when the preparation is mixed with saliva in an oral cavity. The medicine can be quickly absorbed in the systemic circulation through oral mucosa and gastrointestinal tracts after changing into liquid, and the preparation has good mouthfeel, no sand feeling and bitter. The solution coating method adopted in the invention is the first production process in the pharmaceutical industry at home; produced medicines has stable quality; the production efficiency is high; low cost is needed; and the market prospect is extremely broad.
Description
Technical field
The present invention relates to a kind of new oral pharmaceutical preparation and preparation method thereof, particularly a kind of oral instant film preparation and preparation method thereof.
Background technology
On the pharmaceutics pharmaceutical preparation is divided into oral drug preparation and non-oral drug preparation by route of administration.The administration of oral drug preparation oral administration is done through the gastrointestinal absorption performance.As: oral solution, Emulsion, suspensoid, granule, capsule, tablet etc.The oral solution that has that wherein belongs to liquid dosage form, Emulsion, suspensoid etc., and granule, capsule and tablet then belong to solid dosage forms.
The advantage of liquid oral medicament is to take easy easily, does not need to use water delivery service; Its shortcoming is that volume is bigger, and is not portable, needs the container metering when taking, dosage inaccuracy etc.And the advantage of Peroral solid dosage form medicament is that packaging volume is little, carries easily, and taking dose is accurate; Its shortcoming is to need to use water delivery service, brings inconvenience to swallowing inconvenient patient such as old man and child etc.
Summary of the invention
The purpose of this invention is to provide a kind of taking convenience, rapid and the high oral formulations of bioavailability of dissolving, said preparation can be dissolved in saliva rapidly and need not drinking-water in the oral cavity, medicine can enter the body circulation through oral cavity mucosa and gastrointestinal tract rapidly after dissolving, increase bioavailability of medicament, accelerate the drug effect time.
Another object of the present invention provides a kind of preparing such formulations.
Above-mentioned purpose of the present invention realizes by following process:
A kind of oral drug preparation, it is the membrane that the even aqueous dispersions by the active medicine of medicine effective quantity and adjuvant prepares on coating machine with the solution coat method, wherein adjuvant contains at least a high molecular weight water soluble polymer, ion exchange resin and other auxiliary agent.
Described active pharmaceutical ingredient includes but not limited to chemicals, Chinese medicine extraction agent and bioactive ingredients.
The object lesson of active medicine includes but not limited to nitroglycerin, alizapride, cefaclor, benzocaine, caffeine, hydrobromic acid stone dromethan, guaifenesin, loratadine, the L-theanine, omeprazole, pseudoephedrine hydrochloride and vitamin are as nicotinic acid or retinol.
Adjuvant comprises that at least a water-soluble polymer is as film forming matter; Ion exchange resin is used for the bad active medicine of complexation mouthfeel, makes it to discharge in the oral cavity the no obvious abnormal flavour in back; Other auxiliary agent generally includes oral drug preparation odor mask commonly used, plasticizer, food coloring etc.
Described high molecular weight water soluble polymer includes but not limited to natural polymers, modified natural polymer polymer and synthesising macromolecule copolymer.
Water-soluble polymer comprises but does not show pulullan polysaccharide, hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, Polyethylene Glycol, yellow X glue, guar gum, acacin, Radix Acaciae senegalis, polyacrylic acid, methylmethacrylate copolymer, CVP Carbopol ETD2050, amylose, high amylose starches, hydroxypropylation high amylose starches, dextrin, pectin, chitin, chitosan, levan, ossein, gelatin, zein, glutelin, soy protein isolate, lactalbumin isolate, casein and their mixture.
Described ion exchange resin is medicinal anion exchanger resin such as sulfonic group polystyrene-butadiene copolymer resin and medicinal cation exchanger resin such as quaternary amine base polystyrene-butadiene copolymer resin.
Comprise representational flavoring oil in the odor mask, as: Oleum menthae, Oleum Cinnamomi, Fructus Piperis peppermint oil, Oleum Caryophylli, laurel fat, thyme oil, Cedar leaf oil, Semen Myristicae oil, sage oil and Semen Armeniacae Amarum oil.Equally usefully synthetical, natural or synthetic fruit flavor, Rhizoma et radix valerianae for example, chocolate, coffee, cacao bean and mandarin tree oil comprise Fructus Citri Limoniae, orange, Fructus Vitis viniferae, Citrus aurantium Linn. and Fructus Citri grandis, and fruit essence comprise Fructus Mali pumilae, pears, peach, Fructus Fragariae Ananssae, Fructus Rubi, Fructus Pruni pseudocerasi, Fructus Pruni salicinae, Fructus Pruni.
Plasticizer comprises representational ethylene glycol, propylene glycol, xylitol, sorbitol, mannitol, maltose alcohol, lactose, fructose, glucose, sucrose, maltose, glycerol, Polyethylene Glycol.
The preparation technology of preparation of the present invention, carry out according to the following steps:
A) active medicine and ion exchange resin are made the complex of no obvious halitosis by existing technology;
B) high molecular weight water soluble polymer is dissolved in other adjuvant and becomes the homogeneous aqueous solution in the suitable quantity of water;
C) regulate this solution viscosity to 1000～30000cps;
D) stirring adds solution 3 with complex 1 down, stirs;
E) bubble is sloughed in decompression, and is stand-by;
F) solution 5 is transferred to the coating machine head, the polyester stripping film or the separate paper surface that are coated on as substrate become uniform film;
G) transmit and to enter convection oven, under 50～80 ℃ of temperature, remove moisture, make thickness and be 25～250 microns solid film;
E) thin film is cut into suitable size, every film weight is about 50～200 milligrams.
Using method of the present invention is: place on the tongue oral instant medicine film or the Sublingual, be dissolved in saliva in 1 minute rapidly, finish drug administration process.
The invention has the advantages that: the oral instant film preparation of the present invention's preparation, can dissolve rapidly when running into saliva in the oral cavity.After medicine becomes liquid, can enter the body circulation through oral cavity mucosa and gastrointestinal absorption rapidly, good mouthfeel, no sand feeling and bitterness sense, the solution coat method that adopts is the production technology of domestic pharmaceutical industry initiative, and the drug quality of production is stable, the production efficiency height, cost is low, and market prospect is very wide.
Specific embodiment:
Below in conjunction with embodiment the present invention is done detailed explanation.
Embodiment 1:
Prescription:
The present embodiment principal agent is a cefaclor, and the high molecular polymer film former is polyvinyl pyrrolidone and hydroxyethyl-cellulose, and PEG400 is a plasticizer, anion exchange resin, and menthol and sucralose are odor masks, FD﹠amp; The edible red pigments of C is for No. 40 the aesthetic appearance that is used to increase membrane.
The preparation technology of present embodiment, undertaken by following steps:
1. be dissolved in 40 ℃ of water of 1800g by principal agent 15g cefaclor in the above-mentioned prescription, add anion exchange resin, stirred 24 hours;
2. decompress filter is removed moisture, makes cefaclor/anion exchange resin complex;
3. stirred 2 hours in above-mentioned adjuvant 10.4g polyvinyl pyrrolidone and 40 ℃ of water of 11.3g hydroxyethyl-cellulose adding 180g;
4. add 40 ℃ of water of 20g and regulate this solution viscosity to 3500cps;
5. under the vigorous stirring complex 2 is added solution 4, continue to stir 2 hours;
6. stir and add 1.5g menthol, 11.1g sucralose FD﹠amp down; The edible red pigments of C stirred 30 minutes for No. 40;
7. bubble is sloughed in decompression, and is stand-by;
8. solution 7 is transferred to the coating machine head, the separate paper surface that is coated on as substrate becomes uniform film;
9. transmit and enter convection oven, under 50～80 ℃ of temperature, remove moisture, make thickness and be 25 microns solid film;
10. with 25 millimeters of thin film cut growths, wide 15 millimeters small pieces, every film weight is about 50 milligrams.
Embodiment 2:
Prescription:
The present embodiment principal agent is an alizapride, the high molecular polymer film former is polyvinyl pyrrolidone and hydroxypropyl cellulose, PEG400 is a plasticizer, and cation exchange resin (the Amberlite IRA400 of U.S. Rhom and Hass) and xylitol are odor masks, FD﹠amp; No. 1, edible blue pigment of C and red pigments are for No. 40 the aesthetic appearances that is used to increase membrane.
The preparation technology of present embodiment, undertaken by following steps:
1. be dissolved in the 100g dehydrated alcohol by principal agent 5g alizapride in the above-mentioned prescription, add cation exchange resin, stirred 4 hours;
2. dehydrated alcohol is gone out in the rotation distilling under reduced pressure, makes alizapride/cation exchange resin complex;
3. stirred 2 hours in 40 ℃ of water of the low-molecular-weight hydroxypropyl cellulose adding 180g of above-mentioned adjuvant 12.7g polyvinyl pyrrolidone and 17.9g;
4. add 40 ℃ of water of 20g and regulate this solution viscosity to 8400cps;
5. under the vigorous stirring complex 2 is added solution 4, continue to stir 2 hours;
6. stir and add 7.6g xylitol, 0.02g FD﹠amp down; No. 1, edible blue pigment of C and FD﹠amp; The edible red pigments of C stirred 30 minutes for No. 40;
7. bubble is sloughed in decompression, and is stand-by;
8. solution 7 is transferred to the coating machine head, the separate paper surface that is coated on as substrate becomes uniform film;
9. transmit and enter convection oven, under 50～80 ℃ of temperature, remove moisture, make thickness and be 50 microns solid film;
10. with 25 millimeters of thin film cut growths, wide 15 millimeters small pieces, every film weight is 75 milligrams.
The technical specification of embodiment 1,2 is as follows:
Oral instant medicine film is put into 37 ℃ 50ml water bath with thermostatic control, manual time-keeping, dissolution time was less than 1 minute fully.
Claims (6)
1. oral drug preparation, it is characterized in that: it is the membrane that the even aqueous dispersions by the active medicine of medicine effective quantity and adjuvant prepares on coating machine with the solution coat method, wherein adjuvant contains at least a high molecular weight water soluble polymer, ion exchange resin and other auxiliary agent.
2. a kind of oral drug preparation according to claim 1 is characterized in that: described active pharmaceutical ingredient includes but not limited to chemicals, Chinese medicine extraction agent and bioactive ingredients.
3. a kind of oral drug preparation according to claim 1 is characterized in that: described high molecular weight water soluble polymer includes but not limited to natural polymers, modified natural polymer polymer and synthesising macromolecule copolymer.
4. a kind of oral drug preparation according to claim 1 is characterized in that: described ion exchange resin is medicinal anion exchanger resin and medicinal cation exchanger resin.
5. a kind of oral drug preparation according to claim 1 is characterized in that: described active pharmaceutical ingredient content is 1%～50%.
6. the preparation method of the described a kind of oral drug preparation of claim 1 is characterized in that: active medicine and ion exchange resin are made active medicine/ion exchange resin complexes by suitable technology; This complex and other adjuvant are mixed in becomes uniform dispersion soln in the water, on coating machine this dispersion soln is evenly coated polyester stripping film or separate paper surface with the solution coat method and form thin film, at 50 ℃～80 ℃ oven dry and cutting patent medicine film.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110075956 CN102138915A (en) | 2011-03-28 | 2011-03-28 | Oral medicine preparation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110075956 CN102138915A (en) | 2011-03-28 | 2011-03-28 | Oral medicine preparation and preparation method thereof |
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| CN102138915A true CN102138915A (en) | 2011-08-03 |
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| CN 201110075956 Pending CN102138915A (en) | 2011-03-28 | 2011-03-28 | Oral medicine preparation and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040793A (en) * | 2013-01-08 | 2013-04-17 | 于晓勇 | Cefaclor oral instant film preparation and preparation method thereof |
| CN103340841A (en) * | 2013-07-02 | 2013-10-09 | 康美药业股份有限公司 | Chinese medicine film as well as preparation method and application thereof |
| CN104013606A (en) * | 2014-06-24 | 2014-09-03 | 万特制药(海南)有限公司 | Dextromethorphan hydrobromide film agent and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0225615A2 (en) * | 1985-12-09 | 1987-06-16 | Ciba-Geigy Ag | Resinate sustained release dextromethorphan composition |
| US5032393A (en) * | 1988-05-11 | 1991-07-16 | Glaxo Group Limited | Drug adsorbates |
| CN1418624A (en) * | 2002-12-19 | 2003-05-21 | 王登之 | Alizapride oral disintegrant for treating emesis |
| CN1651092A (en) * | 2000-03-23 | 2005-08-10 | 沃尼尔·朗伯公司 | Fast dissolving orally consumable films containing an ion exchange resin as a taste masking agent |
| CN101352442A (en) * | 2008-09-16 | 2009-01-28 | 天津市中央药业有限公司 | Sustained release tablets containing cefaclor active component and preparation method thereof |
-
2011
- 2011-03-28 CN CN 201110075956 patent/CN102138915A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0225615A2 (en) * | 1985-12-09 | 1987-06-16 | Ciba-Geigy Ag | Resinate sustained release dextromethorphan composition |
| US5032393A (en) * | 1988-05-11 | 1991-07-16 | Glaxo Group Limited | Drug adsorbates |
| CN1651092A (en) * | 2000-03-23 | 2005-08-10 | 沃尼尔·朗伯公司 | Fast dissolving orally consumable films containing an ion exchange resin as a taste masking agent |
| CN1418624A (en) * | 2002-12-19 | 2003-05-21 | 王登之 | Alizapride oral disintegrant for treating emesis |
| CN101352442A (en) * | 2008-09-16 | 2009-01-28 | 天津市中央药业有限公司 | Sustained release tablets containing cefaclor active component and preparation method thereof |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040793A (en) * | 2013-01-08 | 2013-04-17 | 于晓勇 | Cefaclor oral instant film preparation and preparation method thereof |
| CN103340841A (en) * | 2013-07-02 | 2013-10-09 | 康美药业股份有限公司 | Chinese medicine film as well as preparation method and application thereof |
| CN103340841B (en) * | 2013-07-02 | 2016-04-20 | 康美药业股份有限公司 | A kind of Chinese medicine membrane, Preparation Method And The Use |
| CN104013606A (en) * | 2014-06-24 | 2014-09-03 | 万特制药(海南)有限公司 | Dextromethorphan hydrobromide film agent and preparation method thereof |
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Application publication date: 20110803 |