盐酸环丙沙星凝胶的微生物限度检查方法  

Method for Microbial Limit Test of Ciprofloxacin Hydrochloride Gel

作　　者：张光华[1] 李玉立[1] 刘文杰[1] 牛振东[1] 江志杰[1] ZHANG Guanghua;LI Yuli;LIU Wenjie;NIU Zhendong;JIANG Zhijie(Beijing Key Lab.of Analysis and Evaluation on Chinese Medicine,NMPA Key Lab.of Research and Evaluation of Generic Drugs,Beijing Institute for Drug Control,Beijing 102206)

机构地区：[1]北京市药品检验所,国家药品监督管理局仿制药研究与评价重点实验室,北京市中药成分分析与生物评价重点实验室,北京102206

出　　处：《中国医药工业杂志》2020年第8期997-1001,共5页Chinese Journal of Pharmaceuticals

摘　　要：本研究建立了盐酸环丙沙星凝胶微生物限度检查方法。利用氯化钙与凝胶剂中的卡波姆结合形成钙盐沉淀,达到破胶目的,使得薄膜过滤可正常进行。按照《中华人民共和国药典》2015年版通则1105、1106、1107,采用薄膜过滤法消除其抑菌性。结果显示,在盐酸环丙沙星凝胶的需氧菌总数、霉菌和酵母菌总数计数方法适用性试验中,各试验菌回收比值均大于0.80,控制菌阳性对照组生长良好。本研究建立了准确可行的盐酸环丙沙星凝胶微生物限度检查方法,也为其他有抑菌性的凝胶剂建立微生物限度检查方法提供参考。In this study,a microbial limit test method for ciprofloxacin hydrochloride gel was established.For gel breaking,calcium chloride was used to combine with the carbomer in the gel so that the membrane filtration could be proceeded normally.According to the general regulations 1105,1106 and 1107 of Chinese pharmacopoeia 2015 edition,membrane filtration was used to eliminate its antibacterial acitivity.The results showed that in the suitability test of the total aerobic bacteria count as well as mold and yeast counts,the recovery ratios of tested bacteria were all more than 0.80,and the bacteria of positive control group grew well.This accurate and feasible microbial limit inspection method for ciprofloxacin hydrochloride gel could provide a reference for the establishment of microbial limit inspection methods for other bacteriostatic gels.

关 键 词：微生物限度 适用性试验 盐酸环丙沙星凝胶 抑菌性 薄膜过滤 

分 类 号：R927.1[医药卫生—药学]