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  

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

作　　者：陶明[1] 杨淑先[1] 周艳梅 TAO Ming;YANG Shu-xian;ZHOU Yan-mei(He′nan Provincial Institute of Food and Drug Control,Henan Zhengzhou 450008,China;Wuxi People′s Hospital,Xin′an Branch Court,Jiangsu Wuxi 214000,China)

机构地区：[1]河南省食品药品检验所,河南郑州450008 [2]无锡人民医院新安分院,江苏无锡214135

出　　处：《中国药物评价》2019年第6期423-426,共4页Chinese Journal of Drug Evaluation

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《中华人民共和国药典》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,采用中和法,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:中和法,薄膜过滤法相结合可消除头孢克洛干混悬剂微生物的抑菌作用,可用于头孢克洛干混悬剂的微生物限度检查。影响头孢克洛干混悬剂的微生物限度方法适用性的因素主要与样品原料的分散性和中和剂的有效单位有关。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 Ⅳ of 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: neutralizing method and 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 main factors affecting the applicability of microbial limit method for cefaclor suspension are the dispersibility of sample materials and the effective units of neutralizer.

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 

分 类 号：R927.33[医药卫生—药学]