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Cefepime hydrochloride for injection and preparation method of cefepime hydrochloride

A technology for cefepime hydrochloride and injection, which is applied in the field of medicinal chemistry, can solve the problems of uneven packaging of cefepime hydrochloride powder, different electrostatic adsorption amounts, and large differences in bulk density, and achieve good packaging uniformity, The effect of improving purity and content and improving stability

Pending Publication Date: 2020-11-20
上海欣峰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Adding an appropriate amount of L-arginine to adjust the pH value can maintain the pH value of cefepime hydrochloride for injection at 4.0-6.0. The content of the substance is greater than 1%, and the change is obvious, and in the long-term sample investigation test, the change of the content of the relevant substance is also obvious, showing that its stability is not good; in addition, the currently commercially available cefepime hydrochloride powder for injection The prescriptions are all a mixture of cefepime hydrochloride and L-arginine, because the bulk density of cefepime hydrochloride and L-arginine is quite different, and the electrostatic adsorption capacity is different, so it is difficult to mix the two evenly, and in The adsorption amount of cefepime hydrochloride on the surface of glass or stainless steel is higher than that of L-arginine, which leads to the change of the ratio of cefepime hydrochloride and L-arginine during the packaging process, which further leads to the increase of cefepime hydrochloride powder for injection. Inhomogeneous packaging and changes in pH value affect the quality of medicines

Method used

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  • Cefepime hydrochloride for injection and preparation method of cefepime hydrochloride
  • Cefepime hydrochloride for injection and preparation method of cefepime hydrochloride
  • Cefepime hydrochloride for injection and preparation method of cefepime hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation of cefepime hydrochloride, such as figure 2 shown, including the following steps:

[0033] (1) Dissolving 50 g of cefepime hydrochloride in 1500 mL of water under stirring conditions at 50-60° C. to obtain an aqueous solution of cefepime hydrochloride;

[0034] (2) the aqueous solution of cefepime hydrochloride prepared in step (1) is carried out membrane separation and impurity removal through a polysulfone membrane with a molecular weight cut-off of 6000D and a polysulfone membrane with a molecular weight cut-off of 2000D under an operating pressure of 0.5MPa, and takes the filtrate;

[0035] (3) Adding a mixed solution of ethanol and ether with a volume ratio of 1:1 to the filtrate prepared in step (2), cooling the temperature to 0-5° C. in an ice-water bath, and cultivating crystals under stirring conditions to obtain a crystallization feed liquid;

[0036] (4) The crystalline liquid obtained in step (3) is filtered, washed, and vacuum-dried to obt...

Embodiment 2

[0043] The preparation of cefepime hydrochloride:

[0044] (1) Dissolving 50 g of cefepime hydrochloride in 2000 mL of water under stirring conditions at 50-60° C. to obtain an aqueous solution of cefepime hydrochloride;

[0045] (2) the cefepime hydrochloride aqueous solution prepared by step (1) is carried out membrane separation and impurity removal through the polysulfone membrane with a molecular weight cut-off of 6000D and the polysulfone membrane with a molecular weight cut-off of 2000D under 0.4MPa operating pressure successively, and takes the filtrate;

[0046] (3) Adding a mixed solution of ethanol and ether with a volume ratio of 1:1 to the filtrate prepared in step (2), cooling the temperature to 0-5° C. in an ice-water bath, and cultivating crystals under stirring conditions to obtain a crystallization feed liquid;

[0047] (4) The crystal feed liquid obtained in step (3) is filtered, washed, and vacuum-dried to obtain a bulk density of 0.42 g / cm 3 of cefepime h...

Embodiment 3

[0054] The preparation of cefepime hydrochloride:

[0055] (1) Dissolving 50 g of cefepime hydrochloride in 1800 mL of water under stirring conditions at 50-60° C. to obtain an aqueous solution of cefepime hydrochloride;

[0056] (2) The cefepime hydrochloride aqueous solution prepared in step (1) is subjected to membrane separation and impurity removal through a sulfonated polysulfone membrane with a molecular weight cut-off of 6000 D and a sulfonated polysulfone membrane with a molecular weight cut-off of 2000 D under an operating pressure of 0.5 MPa , take the filtrate;

[0057] (3) Adding a mixed solution of ethanol and ether with a volume ratio of 1:1 to the filtrate prepared in step (2), cooling the temperature to 0-5° C. in an ice-water bath, and cultivating crystals under stirring conditions to obtain a crystallization feed liquid;

[0058] (4) The crystal feed liquid obtained in step (3) is filtered, washed, and vacuum-dried to obtain a bulk density of 0.53 g / cm 3 o...

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Abstract

The invention discloses cefepime hydrochloride for injection. The cefepime hydrochloride comprises the following components in parts by weight: 100 parts of cefepime hydrochloride, 10-25 parts of a stabilizer, 12-20 parts of a blending agent and 30-50 parts of arginine, wherein the amount of the cefepime hydrochloride is calculated by cefepime; the stabilizer is a mixture of reduced glutathione and L-lysine in a mass ratio of (3-5): 1; and the blending agent is hydroxypropyl-beta-cyclodextrin. By the product, the storage stability of the cefepime hydrochloride is improved, the components of the medicine are uniformly mixed, the subpackaging uniformity is good, and the stability of the pH value of the product before and after subpackaging is ensured.

Description

technical field [0001] The invention relates to the technical field of medicinal chemistry, in particular to a cefepime hydrochloride for injection and a preparation method thereof. Background technique [0002] Cefepime (BMY-28142, CFPM) is a fourth-generation injectable cephalosporin antibiotic developed by Bristol-Myerssquibb. It was first launched in Sweden in 1993 and entered the Chinese market in 1998. . Cefepime hydrochloride for injection, the molecular formula is C 19 h 25 ClN 6 o 5 S 2 ·HCl·H 2 O, molecular weight: 571.50, chemical name: 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo- 5-thia-1-azabicyclo[4,2,0]oct-2-en-3-yl]methyl]-1-methylpyrrolidine chloride, 72-(Z)-(0-methyl Oxime) hydrochloric acid-hydrate, the chemical structural formula is as figure 1 shown. Cefepime hydrochloride for injection is a fourth-generation cephalosporin antibiotic. Compared with third-generation cephalosporins, it has a wider antibacterial spectrum, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/18A61K47/40A61K31/546A61P31/04
CPCA61K9/0019A61K47/183A61K47/40A61K31/546A61P31/04
Inventor 吴王平范海峰卢平平张会芳焦贺标张奇
Owner 上海欣峰制药有限公司
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