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Method for detecting toxicity of cefazedone sodium impurities and intermediates

A technique for detecting the toxicity of cefazedone sodium, which is applied in measuring devices, material inspection products, testing pharmaceutical preparations, etc., can solve the problem of unclear and different cefazedone sodium impurity detection methods, unfavorable production or storage of cefazedone sodium and other issues to achieve the effect of safe and reliable medication and guaranteed safety

Inactive Publication Date: 2011-12-21
天津新丰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, there is no clear regulation on the detection method of cefazedone sodium impurities, and the standards implemented by each manufacturer are not the same. Most manufacturers do not conduct research on the toxicity of impurities at all. Adverse

Method used

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  • Method for detecting toxicity of cefazedone sodium impurities and intermediates
  • Method for detecting toxicity of cefazedone sodium impurities and intermediates
  • Method for detecting toxicity of cefazedone sodium impurities and intermediates

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Embodiment Construction

[0041] Below in conjunction with embodiment, the present invention is further described, and following embodiment is illustrative, not restrictive, can not limit protection scope of the present invention with following embodiment.

[0042] The practical artificial seawater of the present invention is commercially available artificial seawater, and there is no special requirement.

[0043] A kind of preparation method of cefazedone sodium, operation route is as follows:

[0044] first step:

[0045]

[0046] Step two:

[0047]

[0048]

[0049] third step:

[0050]

[0051] 2. Process route diagram and intermediate structure formula:

[0052] 1, the synthesis process flow chart of cefazedone sodium is as figure 1 shown.

[0053] 2. The structural formula of each intermediate

[0054] Table 1 Known impurities of cefoxizone

[0055]

[0056] 3. Analysis of impurities in cefazedone sodium (gradient elution system)

[0057] Gradient elution refers to the elut...

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PUM

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Abstract

The invention relates to a method for detecting toxicity of cefazedone sodium impurities. TU line Zebra fish, Danio rerio Tuebingen serves as a model animal of pharmocotoxicology evaluation. The invention relates to toxicity evaluation of intermediate impurities, byproducts and various degraded impurities of cefazedone sodium in the whole synthetic process. The toxicity of trace impurities in cefazedone is evaluated by chiefly adopting a novel model animal 'zebra fish' of the pharmocotoxicology evaluation, the product quality can be effectively controlled through a zebra fish toxicity test, the safety of clinical use is guaranteed, and a reliable basis is provided for administration safety of a patient.

Description

technical field [0001] The invention relates to the field of toxicity detection of chemical drugs, in particular to a toxicity detection method for the toxicity of cefazedone sodium impurities. Background technique [0002] Cefazedone Sodium, English name: Cefazedone Sodium for Injection, category: β-lactam antibiotics, cephalosporins, chemical structural formula is as follows: [0003] [0004] Cefoxitone sodium is a first-generation cephalosporin researched and developed by E.Merck, Darmstadt laboratory. It was first listed in Germany by E. Merck in 1979, and then in its surrounding countries and countries such as South Korea, Romania, Bulgaria, and Taiwan. Listed by region. Cefoxizone sodium against Staphylococcus aureus, coagulase-negative staphylococcus, Streptococcus pneumoniae, β-hemolytic streptococcus, Haemophilus influenzae, Moraxella catarrhalis, non-ESBL-producing Escherichia coli and Klebsiella pneumoniae Bacillus, Proteus mirabilis, etc. have inhibitory ef...

Claims

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Application Information

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IPC IPC(8): G01N33/15G01N30/02
Inventor 崔连泉刘文玖林澜苏秋菊张梦云
Owner 天津新丰制药有限公司
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