CN103505434A - Cefuroxime axetil tablet and preparation method thereof - Google Patents
Cefuroxime axetil tablet and preparation method thereof Download PDFInfo
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- CN103505434A CN103505434A CN201310420907.9A CN201310420907A CN103505434A CN 103505434 A CN103505434 A CN 103505434A CN 201310420907 A CN201310420907 A CN 201310420907A CN 103505434 A CN103505434 A CN 103505434A
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- cefuroxime axetil
- lactose
- magnesium stearate
- starch sodium
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Abstract
The invention discloses a cefuroxime axetil tablet and a preparation method thereof. The cefuroxime axetil tablet is characterized by comprising the following components: cefuroxime axetil, starch, lactose, micropowder silica gel, a 2% hydroxypropyl methyl cellulose aqueous solution, sodium carboxymethyl starch and magnesium stearate, and the cefuroxime axetil tablet is prepared by reasonably allocating a proportion of the components according to a wet method pelleting tabletting technology. The method solves the problems that cefuroxime axetil meets water or alcohol to generate very high viscosity, and dry method pelleting tabletting or direct powder tabletting can only by adopted generally; special equipment and special auxiliary materials are not required; a qualification rate is high in a production process; and the production cost is lowered.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of cefuroxime axetil tablets and preparation method thereof.
Background technology
CEFUROXIME AXETIL (cefuroxime axetil, Ceftin) be the semi-synthetic cephalosporin of the second filial generation of Britain GlaxoSmithKline PLC company initiative, have wide spectrum, sterilizing power strong, beta-lactamase is had to intrinsic stability, and there are good features such as human pharmacokinetics, blood drug level is high, can penetrate sputum, osseous tissue and inflammation cerebrospinal fluid, the advantage such as nephrotoxicity is little, Orally-administrable.
Domestic existing a plurality of cefuroxime axetil tablets launch, mainly contain zinacef (GlaxoSmithKline PLC), North China pharmacy, Shenzhen and cause the brands such as monarch.Because of CEFUROXIME AXETIL, meet water or the very strong viscosity of ethanol generation, manufacturing enterprise generally believes and cannot adopt wet granule compression tablet both at home and abroad, then adopts dry granulation tabletting or take full pressed powder method.
The preparation method of dry granulation tabletting or full pressed powder, the one, high to adjuvant requirement, most adjuvant needs import; The 2nd, high to equipment requirements, need special equipment; The 3rd, in preparation process, first-time qualification rate is low, causes production cost higher.
Summary of the invention
The object of the invention is to solve the problem that above-mentioned cefuroxime axetil tablets exists in producing, by rational allotment or increase consumption, the usage of existing pharmaceutic adjuvant, can use conventional equipment and conventional adjuvant wet method material tabletting processed.
Cefuroxime axetil tablets provided by the present invention is by CEFUROXIME AXETIL, starch, and lactose, micropowder silica gel, 2% hydroxypropyl emthylcellulose aqueous solution, carboxymethyl starch sodium, magnesium stearate forms, and coating materials is 20% medicinal film coating pre-mix dose aqueous solution.
The preferred parts by weight of component that cefuroxime axetil tablets provided by the present invention comprises are: 160～330 parts of CEFUROXIME AXETIL, 70～120 parts of starch, 10～50 parts of lactose, 40～80 parts of carboxymethyl starch sodium, 20～40 parts of silica particles, 100～200 parts of 2% hydroxypropyl emthylcellulose aqueous solutions, 5～10 parts of magnesium stearate, coating materials is 100～200 parts of 20% medicinal film coating pre-mix dose aqueous solutions.
Cefuroxime axetil tablets provided by the present invention, by following steps, prepare:
1, the CEFUROXIME AXETIL of recipe quantity, starch, lactose are mixed homogeneously with the carboxymethyl starch sodium of part amount;
2, the silica particles that adds recipe quantity, mix homogeneously;
3, the 2% hydroxypropyl emthylcellulose aqueous solution that adds recipe quantity, soft material processed, 16 order nylon screens are granulated, and 60 ℃ are dried 5 ~ 6 hours, 14 order nylon screen granulate;
4, the carboxymethyl starch sodium that adds part amount, the magnesium stearate of recipe quantity, mix homogeneously, surveys granule content, compressed cores;
5, with 20% medicinal film coating pre-mix dose aqueous solution coating of recipe quantity, coating solution sprays at a slow speed, and 40 ~ 50 ℃ of hot air dryings, pack and get final product.
In the preparation method of cefuroxime axetil tablets of the present invention, disintegrating agent carboxymethyl base Starch Sodium adopts inside and outside addition, before granulating, granulate after respectively equivalent add, disintegrate and dissolution rate be ideal comparatively.
The main listing specification of cefuroxime axetil tablets has 125mg(with C
16h
16n
4o
8s meter), 250mg(is with C
16h
16n
4o
8s meter) two kinds.The every 163mg CEFUROXIME AXETIL (C that feeds intake
20h
22n
4o
10s) be equivalent to every and include 125mg cefuroxime.
In the preparation method of cefuroxime axetil tablets of the present invention, the consumption of adjuvant is determined by product specification, the cefuroxime axetil tablets optimal set of 125mg specification becomes: 163 parts of CEFUROXIME AXETIL, 75 parts of starch, 10 parts of lactose, 50 parts of carboxymethyl starch sodium, 20 parts of silica particles, 100 parts of 2% hydroxypropyl emthylcellulose aqueous solutions, 5 parts of magnesium stearate, coating materials is 100 parts of 20% medicinal film coating pre-mix dose aqueous solutions.
The preparation method of cefuroxime axetil tablets of the present invention, the optimal set of 250mg specification becomes: 326 parts of CEFUROXIME AXETIL, 100 parts of starch, 40 parts of lactose, 70 parts of carboxymethyl starch sodium, 40 parts of silica particles, 200 parts of 2% hydroxypropyl emthylcellulose aqueous solutions, 8 parts of magnesium stearate, coating materials is 200 parts of 20% medicinal film coating pre-mix dose aqueous solutions.
The present invention adopts wet granule compression tablet method to prepare cefuroxime axetil tablets, compares with existing dry granulation tabletting or full pressed powder method, does not need special equipment, to adjuvant, require low, and qualification rate is high in production process, improved production efficiency, reduced production cost.
Form is described in further detail content of the present invention more by the following examples, but should not be interpreted as in the above-mentioned subject area of the present invention at this point and only limit to following examples.Do not departing under the above-mentioned technology prerequisite of the present invention, the corresponding replacement of making according to ordinary skill knowledge and customary means or the modification of change, include within the scope of the invention
.
Embodiment 1:
1,163 parts of CEFUROXIME AXETIL, 75 parts of starch, 10 parts of lactose and carboxymethyl starch sodium are 25 parts, mix homogeneously; Then;
2, add 20 parts of silica particles, mix homogeneously;
3, add 100 parts of 2% hydroxypropyl emthylcellulose aqueous solutions, soft material processed, 16 order nylon screens are granulated, and 60 ℃ are dried 5 ~ 6 hours, 14 order nylon screen granulate;
4, add 25 parts of carboxymethyl starch sodium, 5 parts of magnesium stearate, mix homogeneously, surveys granule content, compressed cores;
5, use routinely 100 parts of coatings of 20% medicinal film coating pre-mix dose aqueous solution, coating solution sprays at a slow speed, and 40 ~ 50 ℃ of hot air dryings, pack and get final product.
Embodiment 2:
1,326 parts of CEFUROXIME AXETIL, 100 parts of starch, 40 parts of lactose and carboxymethyl starch sodium are 35 parts, mix homogeneously;
2, add 40 parts of silica particles, mix homogeneously;
3, add 200 parts of 2% hydroxypropyl emthylcellulose aqueous solutions, soft material processed, 16 order nylon screens are granulated, 60 ℃ of dry 5--6 hour, 14 order nylon screen granulate;
4, add 35 parts of carboxymethyl starch sodium, 8 parts of magnesium stearate, mix homogeneously, surveys granule content, compressed cores;
5, use routinely 200 parts of coatings of 20% medicinal film coating pre-mix dose aqueous solution, coating solution sprays at a slow speed, and 40 ~ 50 ℃ of hot air dryings, pack and get final product.
Claims (6)
1. a cefuroxime axetil tablets, is characterized in that comprising following component: CEFUROXIME AXETIL, starch, lactose, micropowder silica gel, 2% hydroxypropyl emthylcellulose aqueous solution, carboxymethyl starch sodium, magnesium stearate forms, and coating materials is 20% medicinal film coating pre-mix dose aqueous solution.
2. the cefuroxime axetil tablets as described in claim 1, it is characterized in that the preferred parts by weight of comprised component are: 160～330 parts of CEFUROXIME AXETIL, 70～120 parts of starch, 10～50 parts of lactose, 40～80 parts of carboxymethyl starch sodium, 20～40 parts of silica particles, 100～200 parts of 2% hydroxypropyl emthylcellulose aqueous solutions, 5～10 parts of magnesium stearate, coating materials is 100～200 parts of 20% medicinal film coating pre-mix dose aqueous solutions.
3. the preparation method of cefuroxime axetil tablets as claimed in claim 1 or 2, adopts wet granule compression tablet technique, it is characterized in that preparing by following steps:
(1) CEFUROXIME AXETIL of recipe quantity, starch, lactose are mixed homogeneously with the carboxymethyl starch sodium of part amount;
(2) add the silica particles of recipe quantity, mix homogeneously;
(3) add 2% hydroxypropyl emthylcellulose aqueous solution of recipe quantity, soft material processed, 16 order nylon screens are granulated, and 60 ℃ are dried 5 ~ 6 hours, 14 order nylon screen granulate;
(4), add the carboxymethyl starch sodium of part amount, the magnesium stearate of recipe quantity, mix homogeneously, surveys granule content, compressed cores;
(5) with 20% medicinal film coating pre-mix dose aqueous solution coating of recipe quantity, coating solution sprays at a slow speed, and 40 ~ 50 ℃ of hot air dryings, pack and get final product.
4. the preparation method of cefuroxime axetil tablets as claimed in claim 3, is characterized in that: disintegrating agent carboxymethyl base Starch Sodium adopts inside and outside addition, and the ratio of weight and number of Nei Jia and additional consumption is 1:1.
5. cefuroxime axetil tablets as claimed in claim 2, its 125mg specification is (with C
16h
16n
4o
8s meter) optimal set of cefuroxime axetil tablets becomes: 163 parts of CEFUROXIME AXETIL, 75 parts of starch, 10 parts of lactose, 50 parts of carboxymethyl starch sodium, 20 parts of silica particles, 100 parts of 2% hydroxypropyl emthylcellulose aqueous solutions, 5 parts of magnesium stearate, coating materials is 100 parts of 20% medicinal film coating pre-mix dose aqueous solutions.
6. cefuroxime axetil tablets as claimed in claim 2, its 250mg specification is (with C
16h
16n
4o
8s meter) optimal set becomes: 326 parts of CEFUROXIME AXETIL, 100 parts of starch, 40 parts of lactose, 70 parts of carboxymethyl starch sodium, 40 parts of silica particles, 200 parts of 2% hydroxypropyl emthylcellulose aqueous solutions, 8 parts of magnesium stearate, coating materials is 200 parts of 20% medicinal film coating pre-mix dose aqueous solutions.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310420907.9A CN103505434A (en) | 2013-09-16 | 2013-09-16 | Cefuroxime axetil tablet and preparation method thereof |
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|---|---|---|---|
| CN201310420907.9A CN103505434A (en) | 2013-09-16 | 2013-09-16 | Cefuroxime axetil tablet and preparation method thereof |
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| CN103505434A true CN103505434A (en) | 2014-01-15 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104666258A (en) * | 2014-12-23 | 2015-06-03 | 北京京丰制药集团有限公司 | Cefuroxime axetil tablet composition and preparation method thereof |
| CN107583056A (en) * | 2017-09-13 | 2018-01-16 | 南通荣成医药化工有限公司 | A kind of Cefuroxime axetil pharmaceutical composition |
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|---|---|---|---|---|
| CN101120927A (en) * | 2007-09-03 | 2008-02-13 | 江苏正大清江制药有限公司 | Wet granulation technology for cefuroxime axetil tablets |
| CN101874791A (en) * | 2009-04-30 | 2010-11-03 | 华北制药集团制剂有限公司 | Cefuroxime axetil tablet and preparation method thereof |
| EP2510922A1 (en) * | 2011-04-14 | 2012-10-17 | Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi | Manufacturing process for tablet formulations comprising cefuroxime |
| CN103006604A (en) * | 2013-01-16 | 2013-04-03 | 南京正宽医药科技有限公司 | Cefuroxime axetil tablets and preparation method thereof |
| WO2013100880A1 (en) * | 2011-12-27 | 2013-07-04 | Mahmut Bilgic | Formulations comprising cefuroxime |
| WO2013109226A1 (en) * | 2012-01-18 | 2013-07-25 | Mahmut Bilgic | Pharmaceutical tablet formulations comprising cefuroxime |
-
2013
- 2013-09-16 CN CN201310420907.9A patent/CN103505434A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101120927A (en) * | 2007-09-03 | 2008-02-13 | 江苏正大清江制药有限公司 | Wet granulation technology for cefuroxime axetil tablets |
| CN101874791A (en) * | 2009-04-30 | 2010-11-03 | 华北制药集团制剂有限公司 | Cefuroxime axetil tablet and preparation method thereof |
| EP2510922A1 (en) * | 2011-04-14 | 2012-10-17 | Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi | Manufacturing process for tablet formulations comprising cefuroxime |
| WO2013100880A1 (en) * | 2011-12-27 | 2013-07-04 | Mahmut Bilgic | Formulations comprising cefuroxime |
| WO2013109226A1 (en) * | 2012-01-18 | 2013-07-25 | Mahmut Bilgic | Pharmaceutical tablet formulations comprising cefuroxime |
| CN103006604A (en) * | 2013-01-16 | 2013-04-03 | 南京正宽医药科技有限公司 | Cefuroxime axetil tablets and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 刘晓艳: "头孢呋辛酯片制剂工艺研究", 《中国医药导报》, vol. 8, no. 32, 30 November 2011 (2011-11-30) * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104666258A (en) * | 2014-12-23 | 2015-06-03 | 北京京丰制药集团有限公司 | Cefuroxime axetil tablet composition and preparation method thereof |
| CN104666258B (en) * | 2014-12-23 | 2017-08-25 | 北京京丰制药集团有限公司 | A kind of cefuroxime axetil tablet composition and preparation method thereof |
| CN107583056A (en) * | 2017-09-13 | 2018-01-16 | 南通荣成医药化工有限公司 | A kind of Cefuroxime axetil pharmaceutical composition |
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Application publication date: 20140115 |