High-purity cefmenoxime hydrochloride and preparation thereof

A cefmenoxime hydrochloride, high-purity technology, applied in the field of medicine, can solve the problems of low purity, poor stability, and large side effects of cefmenoxime hydrochloride, and achieve the effects of improving clarity, stability, and purity

Inactive Publication Date: 2009-01-21
HAINAN SHU ER PHARMA RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Currently used mainly is its hydrochloride form, i.e. cefmenoxime hydrochloride (Cefmenoxime Hemihydrochloride, abbreviated as CMX), but the purity of cefmenoxime hydrochloride in clinical application is not high, resulting in its poor stability and relatively large side effects, thus serious affect its application

Method used

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  • High-purity cefmenoxime hydrochloride and preparation thereof
  • High-purity cefmenoxime hydrochloride and preparation thereof
  • High-purity cefmenoxime hydrochloride and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Take 500 g of cefmenoxime and dissolve it in 2000 ml of purified water, add 2 mol / L hydrochloric acid solution to adjust the pH of the solution to 2.8, then adsorb it with D1300 macroporous resin, and elute with distilled water until there is almost no cefmenoxime hydrochloride in the eluent. Collect the eluate, concentrate the eluate by evaporation under reduced pressure, and use SephadexC 15Carry out column chromatography on a cross-linked Sephadex column as a filler, elute with 0.1mol / L ammonium formate aqueous solution, and the elution temperature is 20°C, collect the part with an integral area ratio of 99% or more detected by HPLC, and add a solution volume of 0.2 % (g / ml) activated carbon, decolorized at room temperature for 30 minutes, sterilized by filtration with a 0.22 μm microporous membrane, and freeze-dried to obtain 441.2 g of cefmenoxime hydrochloride with a purity of 99.3% and a yield of 85.2%.

[0040] After the above-mentioned cefmenoxime hydrochloride...

Embodiment 2

[0042] Take 1000 g of cefmenoxime hydrochloride produced by Suzhou Zhonglian Chemical Pharmaceutical Co., Ltd., stir and dissolve it in 4000 ml of purified water, add 3 mol / L hydrochloric acid solution to adjust the pH of the solution to 3.1, adsorb with D1300 macroporous resin, and elute with distilled water until the There is almost no cefmenoxime hydrochloride in the dehydration. Collect the eluate, concentrate the eluate by evaporation under reduced pressure, and use SephadexC 25 Carry out column chromatography on the cross-linked Sephadex column as filler, elute with 0.2mol / L ammonium acetate aqueous solution, the elution temperature is 25°C, collect the part with an integral area ratio of 99% or more detected by HPLC, add 0.2% of the solution volume % (g / ml) activated carbon, decolorized at room temperature for 30 minutes, sterilized by filtration with a 0.22um microporous membrane, and freeze-dried to obtain 844.0 g of cefmenoxime hydrochloride with a purity of 99.5% an...

Embodiment 3

[0045] Take 800 g of cefmenoxime and dissolve it in 3000 ml of purified water, add 1 mol / L hydrochloric acid solution to adjust the pH of the solution to 2.5, then adsorb it with D1300 macroporous resin, and elute with distilled water until there is almost no cefmenoxime hydrochloride in the eluent. Collect the eluate, concentrate the eluate by evaporation under reduced pressure, and use SephadexC 50 Carry out column chromatography on the cross-linked Sephadex column as filler, elute with 0.2mol / L ammonium propionate aqueous solution, the elution temperature is 23°C, collect the part with an integral area ratio of 99% or more detected by HPLC, add the volume of the solution 0.2% (g / ml) activated carbon, decolorized at room temperature for 30 minutes, sterilized by filtration with a 0.22um microporous membrane, and freeze-dried to obtain 672.77g of cefmenoxime hydrochloride, with a purity of 99.2% and a yield of 81.2% .

[0046] After the above-mentioned cefmenoxime hydrochlor...

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Abstract

The invention provides a method for preparing high purity cefmenoxime Hcl, a method for preparing a powder-injection of high purity cefmenoxime Hcl and high purity cefmenoxime Hcl and the corresponding powder-injection prepared according the methods.

Description

technical field [0001] The invention relates to a method for preparing high-purity cefmenoxime hydrochloride, a method for preparing high-purity cefmenoxime hydrochloride powder injection, and high-purity cefmenoxime hydrochloride and its powder injection prepared according to the method, which belong to medicine technology field. Background technique: [0002] Cefmenoxime, English name: Cefmenoxime, molecular formula: C 16 h 17 N 9 o 5 S 2 , the chemical name is: (6R,7R)-7-[2-(2-amino-4-thiazolyl)(methoxyimino)acetamido]-3-[[1-methyl-1H-tetrazole -5-yl]]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, belonging to the third generation of cephalosporins and semi-synthetic The broad-spectrum cephalosporin antibiotics achieve bactericidal effect by inhibiting the biosynthesis of bacterial cell walls. In vitro tests have shown that this product has effects on both Gram-positive and Gram-negative bacteria. This product has a strong antibacterial effect on Gr...

Claims

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Application Information

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IPC IPC(8): C07D501/36B01D15/32A61K31/546A61K9/14A61P31/04
Inventor 陶灵刚
Owner HAINAN SHU ER PHARMA RES
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