Cefotiam salt compound and pharmaceutical composition made therefrom

A technology of cefotiam and cefotiam hydrochloride, which is applied in the field of cefotiam hydrochloride, can solve the problems of high cefotiam polymer content, reduced drug active ingredient content, increased polymer impurity content, etc. The effect of low content, long validity period and high crystal purity

Inactive Publication Date: 2009-09-30
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] During storage, cefotiam hydrochloride often undergoes degradation and polymerization reactions, especially at high temperatures (>50°C), resulting in a decrease in the active ingredient content of the drug, enhanced color, and increased polymer impurity content
In addition, due to the long storage time of expired cefotiam hydrochloride, the content of active ingredients of the drug is often reduced, the color becomes darker, and the content of polymers increases.
Moreover, in some cases, due to improper control of the production process, the resulting cefotiam or its salts have a particularly high polymer content
When the polymer content is high, it is easy to cause allergic reactions in the human body

Method used

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  • Cefotiam salt compound and pharmaceutical composition made therefrom
  • Cefotiam salt compound and pharmaceutical composition made therefrom
  • Cefotiam salt compound and pharmaceutical composition made therefrom

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Crude cefotiam hydrochloride (produced by Jiangsu Jiushoutang Biological Products Co., Ltd., batch number 20080611), the content of cefotiam recorded by high performance liquid chromatography is 76.8%, and the content of high molecular polymer measured by molecular exclusion chromatography is 6.3% .

[0036] 1). Add 100 g of the crude product of cefotiam hydrochloride into 300 ml of water, stir to dissolve it, and obtain an aqueous solution of cefotiam hydrochloride;

[0037] 2). Cool the aqueous solution to 0°C with cold water, add 2 mol / L sodium hydroxide solution dropwise to the cefotiam hydrochloride aqueous solution under stirring conditions, adjust the pH to 2.0, and white precipitates begin to precipitate;

[0038] 3). Remove the precipitate by filtration to obtain the filtrate; then, cool the obtained filtrate to 0°C with cold water, continue to add dropwise 2mol / L sodium hydroxide solution under stirring, adjust the pH to 3.5, and crystals of cefotiam hydrochlo...

Embodiment 2

[0040] Crude cefotiam (produced by Jiangsu Jiushoutang Biological Products Co., Ltd., batch number 20080523), the content of cefotiam measured by high performance liquid chromatography is 90.1%, and the content of high molecular polymer determined by size exclusion chromatography is 8.6%.

[0041]1). Add 100 g of the above-mentioned cefotiam crude product into 500 ml of water, add hydrochloric acid solution dropwise while stirring to dissolve it, and obtain cefotiam hydrochloride aqueous solution;

[0042] 2). Cool the aqueous solution to 5°C with cold water, add 20% ammonia water dropwise under stirring conditions, adjust the pH to 3.0, and white precipitates begin to precipitate;

[0043] 3). Remove the precipitate by filtration to obtain the filtrate, then add 1.5g of activated carbon, stir and decolorize for 30 minutes, filter and decarburize to obtain the filtrate, cool the filtrate to 5°C, continue to add 20% ammonia water dropwise under stirring, and adjust the pH to 5.0...

Embodiment 3

[0045] Cefotiam hydrochloride powder injection (produced by Shanghai Xinfeng Pharmaceutical Co., Ltd., batch number 20080912), the content of cefotiam recorded by high performance liquid chromatography is 78.3%, and the content of high molecular polymer measured by molecular exclusion chromatography is 5.9%. .

[0046] 1). Add 100 g of the crude product of cefotiam hydrochloride powder injection into 400 ml of water, stir to dissolve it, and obtain an aqueous solution of cefotiam hydrochloride;

[0047] 2). Cool the aqueous solution to about 15°C with cold water, add 1.5 mol / L sodium acetate solution dropwise to the cefotiam hydrochloride aqueous solution under stirring conditions, adjust the pH to 2.7, and white precipitates begin to precipitate;

[0048] 3) Filtration to remove the precipitate to obtain the filtrate; then the obtained filtrate was cooled to about 8°C with cold water, and the sodium acetate solution of 1.5mol / L was continued to be added dropwise under stirrin...

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Abstract

The invention relates to a high-purity cefotiam hydrochloride compound prepared from crystal cefotiam or a crude product of crystal cefotiam salt. The invention also relates to a product obtained according to a purification method of the invention, in particular to a pure cefotiam hydrochloride and a pharmaceutical composition containing the product.

Description

technical field [0001] The present invention relates to a kind of purification method of cefotiam or its salt, more specifically, relate to a kind of method for preparing high-purity cefotiam hydrochloride by crystallization cefotiam or its salt crude product, also relate to according to the purification method of the present invention The prepared product, especially pure cefotiam hydrochloride, and the pharmaceutical composition comprising said product. Background technique [0002] Cefotiam, Chinese synonym: cefotaxime, English name: Cefotiam, is the second-generation bactericidal cephalosporin broad-spectrum antibiotics, the effect on Gram-positive bacteria is similar to that of Cefazolin, and the effect on Gram-positive bacteria is similar to that of Cefazolin. Negative bacteria, such as Haemophilus, Escherichia coli, Klebsiella, and Proteus mirabilis, have strong antibacterial effects on Enterobacter, Citrobacter, and indole-positive Proteus. Its mechanism of action i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12A61K9/14A61K31/546A61P31/04
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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