CN100402035C - A pharmaceutical composition of microencapsulated cefuroxime axetil - Google Patents
A pharmaceutical composition of microencapsulated cefuroxime axetil Download PDFInfo
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- CN100402035C CN100402035C CNB2005100808870A CN200510080887A CN100402035C CN 100402035 C CN100402035 C CN 100402035C CN B2005100808870 A CNB2005100808870 A CN B2005100808870A CN 200510080887 A CN200510080887 A CN 200510080887A CN 100402035 C CN100402035 C CN 100402035C
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- cefuroxime axetil
- microencapsulated
- cefuroxime
- filmogen
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Abstract
The present invention relates to a medicinal composition of microencapsulated cefuroxime axetil and a preparation method thereof. The present invention is characterized in that the microencapsulated cefuroxime axetil is composed of cefuroxime axetil raw materials, film forming materials and additives, wherein the weight ratio of the cefuroxime axetil raw materials and the film forming materials is 1: (0.5 to 5), and the film forming materials are selected from ethyl cellulose and L type acrylic resin or S type acrylic resin. The weight of the additives accounts for 10% to 50% of that of the film forming materials, and the additives are selected from povidone, polyethylene glycol and hydroxypropyl methylcellulose. Prepared granules and dry suspensions have good effect in the aspects of shielding bitterness, increasing in vitro dissolution, etc.
Description
Technical field
The present invention relates to pharmaceutical composition of a kind of microencapsulated cefuroxime axetil and preparation method thereof.
Technical background
CEFUROXIME AXETIL (cefuroxime axetil, Ceftin) chemical name: (6R, 7R)-7-[2-furyl (methoxyimino) acetylamino]-3-carbamyl oxygen methyl-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid, 1-acetoxyl group ethyl ester.
Chemical structural formula:
Molecular formula: C
20H
22N
4O
10S; Molecular weight: 510.48.
CEFUROXIME AXETIL is the semi-synthetic cephalosporin of the second filial generation, advantage such as have has a broad antifungal spectrum, antibacterial activity is strong, and is highly stable to beta-lactamase, and the blood drug level height can penetrate sputum, osseous tissue and inflammation cerebrospinal fluid, and nephrotoxicity is little.Be one of best-selling oral antibiotic in the world at present.
There are 3 kinds of polymorphics in CEFUROXIME AXETIL: fusing point is 180 ℃ a crystalline state, and fusing point is 135 ℃ amorphous, and fusing point is 70 ℃ amorphous.The CEFUROXIME AXETIL of crystalline state slightly soluble in water, the amorphous CEFUROXIME AXETIL water solublity of low melting point is better than crystalline state.Easily form when CEFUROXIME AXETIL contacts with aqueous medium, influenced absorption in external stripping and the body than thick gel.This medicine is bitter simultaneously, and this bitterness is persistent and can not be by adding sweetener routinely and correctives is sheltered, thereby makes that patient's drug compliance is poor, especially is unfavorable for child's administration.
The CN1421206A of Britain Glaxo Group Ltd application, disclosed a kind of compositions, compositions comprises granular CEFUROXIME AXETIL, this granule carries out coating with the complete coating of lipid or lipid mixture, this coating water fast adds the bitterness of sweetener and structure improving agent CEFUROXIME AXETIL when being used to shelter oral administration again.The used main material of CEFUROXIME AXETIL coating is a stearic acid water-insoluble lipid in this patent, and external stripping is slower, the manufacturing process complexity.
CN1367683A by Hanmi Pharm Ind. Co., Ltd's application has disclosed a kind of amorphism CEFUROXIME AXETIL solid dispersion, its preparation is by CEFUROXIME AXETIL and surfactant are dissolved in the organic solvent, the water-insoluble inorganic carrier is suspended in the gained solution, and dry gained suspension removes and desolvates.Described solid dispersion has improved the bioavailability and the stability of CEFUROXIME AXETIL, but used water-insoluble inorganic carrier can't form encapsulation to CEFUROXIME AXETIL, reaches the purpose of covering its bitterness.
Given this, need a kind of pharmaceutical preparation that contains CEFUROXIME AXETIL and preparation method that can obviously reduce bitterness and not influence stripping and absorption.
Summary of the invention
The purpose of this invention is to provide pharmaceutical composition of the microencapsulated cefuroxime axetil that can overcome the CEFUROXIME AXETIL bitterness, improve stripping and absorption and preparation method thereof, and the application in oral formulations.
Microencapsulated cefuroxime axetil is made up of CEFUROXIME AXETIL raw material, filmogen and additives, and CEFUROXIME AXETIL raw material and filmogen weight ratio are 1: 0.5～5, and preferred weight ratio 1: 1～3, filmogen are selected from ethyl cellulose, acrylic resin L or S type.Additives account for filmogen weight 10%～50%, and additives are selected from polyvidone, Polyethylene Glycol, hydroxypropyl emthylcellulose.
The CEFUROXIME AXETIL raw material can be the mixture of CEFUROXIME AXETIL, crystallization and amorphous form of CEFUROXIME AXETIL, the amorphous form of crystal form.
The selection of filmogen is most important, we have carried out CEFUROXIME AXETIL and ethyl cellulose, the test of different model acrylic resin compatibility stability thus, test method: CEFUROXIME AXETIL and filmogen are dissolved in 95% ethanol, stirred 8 hours, observe the solution appearance change color, and detect related substance.Result of the test finds that CEFUROXIME AXETIL and ethyl cellulose, CEFUROXIME AXETIL and acrylic resin L type, CEFUROXIME AXETIL and acrylic resin S type solution all do not have change color, detects relevant thing in limits, and compatibility is stable in 8 hours.CEFUROXIME AXETIL and Eudragit E type, CEFUROXIME AXETIL and acrylic resin RL type, CEFUROXIME AXETIL and acrylic resin RS type solution colour all redden in half an hour, detect the equal overrun of relevant thing, the compatibility instability.So we use ethyl cellulose, acrylic resin L type or acrylic resin S type as filmogen.
The additives that add in the microencapsulation process can increase stripping effectively, screening by experiment, and polyvidone, Polyethylene Glycol, hydroxypropyl emthylcellulose are to be suitable for additives of the present invention.
The microencapsulated cefuroxime axetil preparation process is as follows: after dissolving in filmogen, the additives adding ethanol, CEFUROXIME AXETIL is added in the above-mentioned solution dissolving or is the suspendible kilter, liquid after mixing carries out spray drying, 60～80 ℃ of inlet temperatures, 30～50 ℃ of outlet temperatures, obtain microencapsulated cefuroxime axetil, be Powdered.Observe most of CEFUROXIME AXETIL raw material under the Electronic Speculum by microencapsulation, be and the mixed uniformly microsphere of filmogen than small part.
The pharmaceutical composition of microencapsulated cefuroxime axetil of the present invention is very suitable for preparing oral formulations such as granule, dry suspension.For granule, need to add sweeting agent, correctives, suspending agent, disintegrating agent, the weight ratio of each component is: microencapsulated cefuroxime axetil 10～60%, suspending agent 1～5%, disintegrating agent 1～10%, sweeting agent 30～80%, correctives 0～2%.
Sweeting agent comprises but is not limited to Icing Sugar, lactose, mannitol, sorbitol, aspartame, Sucralose, saccharin sodium, stevioside, erythrose.
Correctives includes but not limited to orange flavor, flavoring orange essence, strawberry essence, cherry essence, milk chocolate essence, cream flavour.
Suspending agent includes but not limited to hydroxypropyl emthylcellulose, methylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, tragakanta, polyvidone, sodium carboxymethyl cellulose.
Disintegrating agent includes but not limited to sodium lauryl sulphate, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium.
The pharmaceutical composition of microencapsulated cefuroxime axetil of the present invention for dry suspension, needs to add sweeting agent, correctives, suspending agent, the weight ratio of each component is: microencapsulated cefuroxime axetil 10～60%, suspending agent 1～10%, sweeting agent 30～80%, correctives 0～2%.
Sweeting agent comprises but is not limited to Icing Sugar, lactose, mannitol, sorbitol, aspartame, Sucralose, saccharin sodium, stevioside, erythrose.
Correctives includes but not limited to orange flavor, flavoring orange essence, strawberry essence, cherry essence, milk chocolate essence, cream flavour.
Suspending agent includes but not limited to hydroxypropyl emthylcellulose, methylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, sucrose fatty acid ester, tragakanta, polyvidone, micropowder silica gel, carboxymethyl cellulose sodium, sodium citrate.
The present invention adopts spray drying process to obtain microencapsulated cefuroxime axetil, reaches the purpose of fundamentally covering bitterness, and guarantees that by additives the stripping of CEFUROXIME AXETIL is good.Add pharmaceutic adjuvants such as sweeting agent, correctives again, obtain good result aspect the bitterness covering.The external stripping height of this pharmaceutical composition, CEFUROXIME AXETIL raw material stable configuration meets drug standard.
The specific embodiment
Further specify the present invention with hereinafter embodiment, used embodiment should not be construed as limiting the invention.
Embodiment one, preparation microencapsulated cefuroxime axetil
Take by weighing after ethyl cellulose 50g, polyvidone 25g add in 95% ethanol dissolving, CEFUROXIME AXETIL 100g is added in the above-mentioned solution dissolving or is the suspendible kilter, liquid after mixing is in spray dryer (QP3 type, Beijing Chemical Research Inst. Ministry of Chemical Industry) carries out spray drying in, 80 ℃ of inlet temperatures, 50 ℃ of outlet temperatures obtain microencapsulated cefuroxime axetil, are Powdered.
Embodiment two, preparation microencapsulated cefuroxime axetil
Repeat embodiment one operating procedure, but used ethyl cellulose is 100g, polyvidone is 50g.
Embodiment three, preparation microencapsulated cefuroxime axetil
Taking by weighing ethyl cellulose 200g, polyethylene glycol 1500 and be 50g adds in 95% ethanol after the dissolving, CEFUROXIME AXETIL 100g is added in the above-mentioned solution dissolving or is the suspendible kilter, liquid after mixing is in spray dryer (QP3 type, Beijing Chemical Research Inst. Ministry of Chemical Industry) carries out spray drying in, 70 ℃ of inlet temperatures, 40 ℃ of outlet temperatures obtain microencapsulated cefuroxime axetil, are Powdered.
Embodiment four, preparation microencapsulated cefuroxime axetil
Taking by weighing ethyl cellulose 500g, PEG400 and be 200g adds in 95% ethanol after the dissolving, CEFUROXIME AXETIL 100g is added in the above-mentioned solution dissolving or is the suspendible kilter, liquid after mixing is in spray dryer (QP3 type, Beijing Chemical Research Inst. Ministry of Chemical Industry) carries out spray drying in, 70 ℃ of inlet temperatures, 40 ℃ of outlet temperatures obtain microencapsulated cefuroxime axetil, are Powdered.
Embodiment five, preparation microencapsulated cefuroxime axetil
Take by weighing after acrylic resin L type 300g, hydroxypropyl emthylcellulose 100g add in 80% ethanol dissolving, CEFUROXIME AXETIL 100g is added in the above-mentioned solution dissolving or is the suspendible kilter, liquid after mixing is in spray dryer (QP3 type, Beijing Chemical Research Inst. Ministry of Chemical Industry) carries out spray drying in, 80 ℃ of inlet temperatures, 50 ℃ of outlet temperatures obtain microencapsulated cefuroxime axetil, are Powdered.
Embodiment six, preparation microencapsulated cefuroxime axetil
Take by weighing after acrylic resin S type 400g, hydroxypropyl emthylcellulose 50g add in 80% ethanol dissolving, CEFUROXIME AXETIL 100g is added in the above-mentioned solution dissolving or is the suspendible kilter, liquid after mixing is in spray dryer (QP3 type, Beijing Chemical Research Inst. Ministry of Chemical Industry) carries out spray drying in, 80 ℃ of inlet temperatures, 50 ℃ of outlet temperatures obtain microencapsulated cefuroxime axetil, are Powdered.
Embodiment seven, microencapsulated cefuroxime axetil granule
Prescription: cefuroxime axetil granule 125mg/2g (in cefuroxime)
1000 bags of dosage of component
The CEFUROXIME AXETIL of microencapsulation
270g
(embodiment 1)
Microcrystalline Cellulose 100g
Carboxymethyl starch sodium 150g
Sucralose 20g
Erythrose 1400g
Distilled water is granulated an amount of
Add sodium carboxymethyl cellulose 40g
Flavoring orange essence 20g
Operation:, prepare cefuroxime axetil granule with the conventional preparation method of granule by the prescription consumption.
Embodiment eight, microencapsulated cefuroxime axetil granule
Prescription: cefuroxime axetil granule 125mg/2g (in cefuroxime)
1000 bags of dosage of component
The CEFUROXIME AXETIL of microencapsulation
370g
(embodiment 3)
Microcrystalline Cellulose 150g
Low-substituted hydroxypropyl cellulose 38g
Sodium lauryl sulphate 18g
Carboxymethyl starch sodium 100g
Xylitol 1279g
Saccharin sodium 20g
Distilled water is granulated an amount of
Add tragakanta 10g
Vanilla 15g
Operation:, prepare cefuroxime axetil granule with the conventional preparation method of granule by the prescription consumption.
Embodiment nine, microencapsulated cefuroxime axetil dry suspension
Prescription: CEFUROXIME AXETIL dry suspension 125mg/1.5g (in cefuroxime)
1000 bags of dosage of component
The CEFUROXIME AXETIL of microencapsulation
772g
(embodiment 5)
Mannitol 690g
Sucralose 8g
Sodium carboxymethyl cellulose 20g
Butter vanilla 10g
Operation:, prepare the CEFUROXIME AXETIL dry suspension with the conventional preparation method of dry suspension by the prescription consumption.
Embodiment ten, cefuroxime axetil granule agent
We have prepared the CEFUROXIME AXETIL solid dispersion with reference to the described method of CN1367683, and change slightly with reference to tablet formulation among the CN1367683 embodiment, draft cefuroxime axetil granule agent prescription:
Component
CEFUROXIME AXETIL 154g
Tween 80 24g
Silicon dioxide 24g
Microcrystalline Cellulose 25g
Polyvinylpolypyrrolidone 55g
Magnesium stearate 2.5g
Operation: by the prescription consumption, prepare solid dispersion, prepare the cefuroxime axetil granule agent with the conventional preparation method of granule then with reference to the CN1367683 method.
Embodiment 11, CEFUROXIME AXETIL dry suspension
We have prepared CEFUROXIME AXETIL Pharmaceutical composition behind the complete coating of lipid by CN1421206A, change slightly with reference to listed examples suspensoid prescription among the CN1421206A, draft CEFUROXIME AXETIL dry suspension prescription:
Component
CEFUROXIME AXETIL 151g
Stearic acid 853g
Povidone 14g
Tutti Frutti correctives 100g
Sucrose 3062g
Saccharin sodium 22g
Radix asparagi sweet extract 22g
Xanthan gum 1g
Operation: prepare the CEFUROXIME AXETIL dry suspension with the conventional preparation method of dry suspension after the CEFUROXIME AXETIL lipid coating.
Embodiment 12, mouthfeel taste test
Embodiment seven, embodiment nine, embodiment ten, embodiment 11 adds an amount of warm water respectively and is suspension.Carry out taste test in some health adults, the result who shows in the following table has provided the percentage ratio of patient to its mouthfeel.
The result clearly illustrates that the embodiment of the invention seven, nine compares with the comparative example respectively, and taste has obtained very big improvement, and along with the increase of filmogen with respect to CEFUROXIME AXETIL weight, mouthfeel is improved also more obvious.
Embodiment 13, stripping experiment
Embodiment seven, embodiment nine, embodiment ten, embodiment 11 are according to dissolution method (two appendix XC second methods of Chinese Pharmacopoeia version in 2005), with the 0.07mol/L hydrochloric acid solution is solvent, rotating speed is that per minute 55 changes, sampling solution 5ml when 15 minutes and 45 minutes respectively, wavelength place at 278nm measures trap, and test data sees the following form.
The result clearly illustrates that the embodiment of the invention seven, nine compares with embodiment 11, and stripping is greatly improved under the prerequisite that guarantees mouthfeel, and is suitable with embodiment ten dissolutions.
Claims (5)
1. the pharmaceutical composition of a microencapsulated cefuroxime axetil, it is characterized in that microencapsulated cefuroxime axetil is by CEFUROXIME AXETIL, filmogen and additives are formed, CEFUROXIME AXETIL and filmogen weight ratio are 1: 0.5～5, filmogen is selected from ethyl cellulose, acrylic resin L type or acrylic resin S type, additives account for filmogen weight 10%～50%, additives are selected from polyvidone, Polyethylene Glycol or hydroxypropyl emthylcellulose, CEFUROXIME AXETIL are selected from the CEFUROXIME AXETIL of crystal form, the blended CEFUROXIME AXETIL of the CEFUROXIME AXETIL of amorphous form or crystallization and amorphous form.
2. according to the pharmaceutical composition of the described microencapsulated cefuroxime axetil of claim 1, it is characterized in that CEFUROXIME AXETIL and filmogen weight ratio preferred 1: 1～3.
3. according to the pharmaceutical composition of claim 1 or 2 described microencapsulated cefuroxime axetils, it is characterized in that adding sweeting agent, correctives, suspending agent and disintegrating agent, make granule.
4. according to the pharmaceutical composition of claim 1 or 2 described microencapsulated cefuroxime axetils, it is characterized in that adding sweeting agent, correctives and suspending agent, make dry suspension.
5. the preparation of drug combination method of a microencapsulated cefuroxime axetil as claimed in claim 1, it is characterized in that: measure in proportion after the dissolving in filmogen, the additives adding ethanol, again the CEFUROXIME AXETIL of proportional quantities is added in the above-mentioned solution dissolving or be the suspendible kilter, liquid after mixing carries out spray drying, 60～80 ℃ of inlet temperatures, 30～50 ℃ of outlet temperatures obtain microencapsulated cefuroxime axetil, are Powdered.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100808870A CN100402035C (en) | 2005-07-07 | 2005-07-07 | A pharmaceutical composition of microencapsulated cefuroxime axetil |
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| CNB2005100808870A CN100402035C (en) | 2005-07-07 | 2005-07-07 | A pharmaceutical composition of microencapsulated cefuroxime axetil |
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| CN100402035C true CN100402035C (en) | 2008-07-16 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102440960A (en) * | 2011-09-01 | 2012-05-09 | 山东鲁抗医药股份有限公司 | Pharmaceutical composition of cefuroxime axetil for suspension and preparation method thereof |
| CN105125544A (en) * | 2015-07-15 | 2015-12-09 | 江苏阿尔法药业有限公司 | Chewable medicine tablet for treating child allergic rhinitis |
| CN112007010A (en) * | 2020-08-11 | 2020-12-01 | 江苏正大清江制药有限公司 | Stable cefuroxime axetil pharmaceutical preparation composition and preparation method thereof |
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| CN88102851A (en) * | 1987-05-14 | 1988-12-21 | 格拉克索集团有限公司 | Method for preparing pharmaceutical composition |
| WO1999008683A1 (en) * | 1997-08-15 | 1999-02-25 | Bernard Charles Sherman | Pharmaceutical compositions comprising cefuroxime axetil |
| WO2000030647A1 (en) * | 1998-11-26 | 2000-06-02 | Biochemie Gesellschaft M.B.H. | Compositions comprising cefuroxime axetil |
| US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| CN1367683A (en) * | 1999-08-04 | 2002-09-04 | 韩美药品工业株式会社 | Non-crystalline cefuroxime axetil solid dispersant, process for preparing same and composition for oral administration thereof |
| CN1421206A (en) * | 2001-11-23 | 2003-06-04 | 葛兰素集团有限公司 | Medical composition |
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2005
- 2005-07-07 CN CNB2005100808870A patent/CN100402035C/en active Active
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| CN88102851A (en) * | 1987-05-14 | 1988-12-21 | 格拉克索集团有限公司 | Method for preparing pharmaceutical composition |
| WO1999008683A1 (en) * | 1997-08-15 | 1999-02-25 | Bernard Charles Sherman | Pharmaceutical compositions comprising cefuroxime axetil |
| WO2000030647A1 (en) * | 1998-11-26 | 2000-06-02 | Biochemie Gesellschaft M.B.H. | Compositions comprising cefuroxime axetil |
| CN1367683A (en) * | 1999-08-04 | 2002-09-04 | 韩美药品工业株式会社 | Non-crystalline cefuroxime axetil solid dispersant, process for preparing same and composition for oral administration thereof |
| US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| CN1421206A (en) * | 2001-11-23 | 2003-06-04 | 葛兰素集团有限公司 | Medical composition |
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| PN:KR20050038251A20050427 2005.04.27 * |
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Effective date of registration: 20111208 Address after: 050051 No. 276 West Zhongshan Road, Hebei, Shijiazhuang Co-patentee after: Zhijun Pharmaceutical Co., Ltd., Shenzhen Patentee after: Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. of CSPC Group Address before: 050051 No. 276 West Zhongshan Road, Hebei, Shijiazhuang Patentee before: Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. of CSPC Group |
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Address after: 050051 No. 276 West Zhongshan Road, Hebei, Shijiazhuang Patentee after: Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. of CSPC Group Patentee after: Sinopharm (Shenzhen) Pharmaceutical Co., Ltd. Address before: 050051 No. 276 West Zhongshan Road, Hebei, Shijiazhuang Patentee before: Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. of CSPC Group Patentee before: Zhijun Pharmaceutical Co., Ltd., Shenzhen |