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Cefmenoxime hydrochloride and low-sodium carrier drug composition for children

A technology of cefmenoxime hydrochloride and its composition, which is applied in the field of medicinal chemistry, can solve the problems of poor stability, increase of impurities, difficulty in dissolving cefmenoxime hydrochloride, etc., achieve good stability, reduce impurities, and improve the quality of clinical application

Inactive Publication Date: 2015-09-16
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the difficulty in dissolving cefmenoxime hydrochloride and the poor stability of cephalosporin products in solution, too long time in dissolution will cause degradation of cefmenoxime and increase of impurities

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] (1) Weigh 100g of crude cefmenoxime, add 1000ml of water, slowly add 4% sodium bicarbonate solution dropwise with stirring until clear, add 10ml of ethyl acetate under stirring, transfer to a 1000ml pressure-resistant container, ensure that it is full and remove air bubbles, seal Container, shake, freeze at -18°C for 3 hours and take out;

[0036] (2) remove the organic phase, after the ice melts, add 10 g of activated carbon, stir to decolorize, and filter;

[0037] (3) Transfer the filtrate to the crystallization tank, control the temperature to 10-15°C, adjust the pH to 1.5 with dilute hydrochloric acid, continue to grow the crystals for 1 hour, filter with suction, wash with water, and vacuum dry at 40°C. Maximum single miscellaneous 0.13%, total miscellaneous 0.23%.

Embodiment 2

[0039] (1) Weigh 100 g of cefmenoxime crude product, add 1000 ml of water, slowly add 4% sodium bicarbonate solution dropwise with stirring until clear, add 10 ml of chloroform under stirring, transfer to a 1000 ml pressure-resistant container, ensure that it is full and remove air bubbles, seal the container, Shake, freeze at -18°C for 3 hours and take out;

[0040] (2) remove the organic phase, after the ice melts, add 10 g of activated carbon, stir to decolorize, and filter;

[0041] (3) Transfer the filtrate to a crystallizing tank, control the temperature to 10-15°C, adjust the pH to 1.7 with dilute hydrochloric acid, continue to grow crystals for 1 hour, filter with suction, wash with water, and vacuum dry at 40°C. Maximum single miscellaneous 0.19%, total miscellaneous 0.29%.

Embodiment 3

[0043] (1) Weigh 100 g of cefmenoxime crude product, add 1000 ml of water, slowly add 4% sodium bicarbonate solution dropwise with stirring until clear, add 7 ml of ethyl acetate under stirring, transfer to a 1000 ml pressure-resistant container, ensure that it is full and remove air bubbles, seal Container, shake, freeze at -18°C for 3 hours and take out;

[0044] (2) remove the organic phase, after the ice melts, add 10 g of activated carbon, stir to decolorize, and filter;

[0045] (3) Transfer the filtrate to the crystallization tank, control the temperature to 10-15°C, adjust the pH to 1.5 with dilute hydrochloric acid, continue to grow the crystals for 1 hour, filter with suction, wash with water, and vacuum dry at 40°C. Maximum single miscellaneous 0.17%, total miscellaneous 0.24%.

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Abstract

The invention relates to a cefmenoxime hydrochloride drug composition for children, namely, a drug composition preparation of cefmenoxime hydrochloride and a low-sodium carrier infusion solution, in particular to a composition application package. The composition comprises the cefmenoxime hydrochloride and the low-sodium carrier infusion solution for injection. The low-sodium carrier infusion solution comprises a dextrose and sodium chloride injection (15-200:1), a glucose, sodium chloride and potassium chloride injection (15-200:1:0-1) and the like. Relative to the compatible and mixed use of the cefmenoxime hydrochloride and the low-sodium carrier infusion solution, clinical application steps are simplified. The clinical risks caused due to the fact that the kidneys of the children are not mature and are incapable of metabolizing too much sodium existing in blood are reduced. The clinical application quality and safety of child drugs are improved.

Description

technical field [0001] The invention relates to a child-type cefmenoxime hydrochloride and a low-sodium carrier pharmaceutical composition, belonging to the field of medicinal chemistry. Background technique [0002] The chemical name of Cefmenoxime hydrochloride is (6R,7R)-7-[2-(2-amino-4-thiazolyl)(methoxyimino)acetamido]-3-[[(1-methyl-1H -Tetrazol-5-yl)-thio]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate hydrochloride, also known as aminothiazide Oximazole cephalosporins and bestec are third-generation cephalosporins that have antibacterial effects on Gram-negative and positive aerobic and anaerobic bacteria. Among gram-negative bacteria, the antibacterial effect on Escherichia coli and Pneumococcus is slightly stronger than that of cefotiam, significantly stronger than that of the first-generation cefazolin, and it has antibacterial effects on Haemophilus influenzae, Proteus, Serratia marcescens, and lemon. The antibacterial effects of Acidobacter and Enterob...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/546A61P31/04
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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