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中国药物评价 ›› 2019, Vol. 36 ›› Issue (6): 423-426.

• 评价技术与方法 • 上一篇    下一篇

进口与国产头孢克洛干混悬剂的微生物限度检查方法及影响因素分析

陶明1,1,杨淑先1,周艳梅2   

  1. 1. 河南省食品药品检验所
    2. 无锡耘林康复医院
  • 收稿日期:2019-11-28 修回日期:2019-12-17 出版日期:2019-12-28 发布日期:2020-01-21
  • 基金资助:

Study on Microbial Limit Test Methods and Influencing Factors of Imported and Domestic Cefaclor Suspension

  • Received:2019-11-28 Revised:2019-12-17 Online:2019-12-28 Published:2020-01-21

摘要: 目的 建立进口和国产头孢克洛干混悬剂的微生物限度检查方法,并比较分析影响因素。方法 根据《中国药典》2015年版四部通则1105非无菌产品微生物限度检查:微生物计数法,通则1106非无菌产品微生物限度检查:控制菌检查法和通则1107非无菌药品微生物限度标准,采用加入中和剂法,薄膜过滤法相结合建立头孢克洛干混悬剂的微生物限度检查方法的适用性试验。结果 计数方法适用性试验中,稀释剂对照组菌落数与菌液对照组菌落数的比值均在0.5~2之间,试验组菌落数减去供试品对照组菌落数与菌液对照组菌落数的比值均在0.5~2之间;控制菌检查方法适用性试验中,试验组检出阳性试验菌。结论 中和剂法,薄膜过滤法相结合的方法可消除头孢克洛干混悬剂的微生物限度检查方法的抑菌作用,可用于头孢克洛干混悬剂的微生物限度检查方法的微生物限度检查。进口与国产样品为消除抑菌性过滤所用的缓冲液的量有不同,分析原因可能与样品的分散性和溶出度等有关。

关键词: 头孢克洛干混悬剂, 微生物限度检查方法适用性试验, 薄膜过滤法, 中和法

Abstract: Objective To establish microbial limit test methods for imported and domestic cefaclor suspension, and compare them.METHODS According to 1105 microbiological examination of non-sterile products: microbial enumeration tests,1106 microbiological examination of non-sterile products: tests for specified microorganisms and 1107 microbiologicalexamination standards of non-sterile products in the appendices volume Ⅳof Chinese Pharmacopeia(edition 2015),this article provides a method for microbial limit test of imported Cefaclor Suspension. A combination of the below measures were used to remove the antimicrobial activity in suitability of microbial limit test method. (1) Incorporation of β-lactamase into the diluent; (2)membrane-filter method.RESULTS In the test for microbial enumeration,the ratio between Neutralizing group and microorganism solution group were between 0.5 and 2.The ratio between test group minus sample solution group and microorganism solution group were between 0.5 and 2. In the test for specified microorganisms ,the control bacteria was found in the test group.CONCLUSION The combination of neutralizer method and membrane filtration method can eliminate the Bacteriostasis of the microbial limit test of cefaclor dry suspension, and can be used for microbial limit test of cefaclor suspension. The filter capacity of imported samples is different from that of domestic samples. The reason for analysis may be related to the dispersion and dissolution of samples.

Key words: Cefaclor Suspension, Microbial limit test and suitability, Membrane- filter method, Neutralizing method