Cefuroxime axetil tablet and preparation method thereof

A technology for cefuroxime axetil and furoxamil tablets is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, medical preparations containing active ingredients, etc. Advanced problems, to achieve the effect of improving product production efficiency, low requirements for auxiliary materials, and high qualification rate

Inactive Publication Date: 2014-01-15
JIANGSU QINGJIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The preparation method of dry granulation tableting or whole powder tableting, firstly, has high requirements on excipients, most of which need to be imported; secondly, has high requirements on equipment and needs special equipment; thirdly, in the preparation process, the first pass rate is low , resulting in higher production costs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] 1. Mix 163 parts of cefuroxime axetil, 75 parts of starch, 10 parts of lactose and 25 parts of sodium carboxymethyl starch; then;

[0022] 2. Add 20 parts of micro silica gel and mix well;

[0023] 3. Add 100 parts of 2% hydroxypropyl methylcellulose aqueous solution to make soft material, granulate with 16-mesh nylon screen, dry at 60°C for 5-6 hours, and granulate with 14-mesh nylon screen;

[0024] 4. Add 25 parts of sodium carboxymethyl starch and 5 parts of magnesium stearate, mix well, measure the content of granules, and compress the tablet core;

[0025] 5. Coat with 100 parts of 20% pharmaceutical film coating premix aqueous solution according to the routine, spray the coating solution slowly, dry with hot air at 40~50°C, and pack.

Embodiment 2

[0027] 1. 326 parts of cefuroxime axetil, 100 parts of starch, 40 parts of lactose and 35 parts of sodium carboxymethyl starch, mix well;

[0028] 2. Add 40 parts of micro silica gel and mix well;

[0029] 3. Add 200 parts of 2% hydroxypropyl methylcellulose aqueous solution to make soft material, granulate with 16-mesh nylon screen, dry at 60°C for 5-6 hours, and granulate with 14-mesh nylon screen;

[0030] 4. Add 35 parts of sodium carboxymethyl starch and 8 parts of magnesium stearate, mix well, measure the content of granules, and compress the tablet core;

[0031] 5. Coat with 200 parts of 20% aqueous solution of pharmaceutical film coating premix as usual, spray the coating solution slowly, dry with hot air at 40-50°C, and pack.

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PUM

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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 [0001] The invention relates to the field of pharmaceutical preparations, in particular to a cefuroxime axetil tablet and a preparation method thereof. Background technique [0002] Cefuroxime axetil (Ceftin) is a second-generation semi-synthetic cephalosporin created by GlaxoSmithKline. It has the characteristics of human pharmacokinetics, high blood concentration, can penetrate into sputum, bone tissue and inflammatory cerebrospinal fluid, has little nephrotoxicity, and can be administered orally. [0003] A number of cefuroxime axetil tablets have been launched in China, mainly Xilixin (GlaxoSmithKline), North China Pharmaceutical, Shenzhen Zhijun and other brands. Due to the very strong viscosity of cefuroxime axetil when it meets water or ethanol, manufacturers at home and abroad generally believe that wet granulation cannot be used for tabletting, and instead adopt dry granulation or full powder tabletting. [0004] The preparation method of dry granu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/546A61K47/38A61P31/04
Inventor 滕奇顾海成
Owner JIANGSU QINGJIANG PHARMA
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