摘要
目的:探索消除林可霉素利多卡因凝胶抑菌活性的适宜方法,并建立该品种微生物限度检查方法。方法:根据2015年版《中华人民共和国药典》(以下简称中国药典)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,利用3%氯化钡溶液能与林可霉素利多卡因凝胶中的主要基质卡波姆形成钡盐沉淀达到破胶目的的原理,自然沉降5 min,取上部溶液进行薄膜过滤,采用薄膜过滤法测定林可霉素利多卡因凝胶对5种试验菌株的回收率,并对控制菌检查方法进行适用性试验。结果:在对样品进行需氧菌总数、霉菌和酵母菌计数方法适用性试验中,稀释剂对照组与菌液对照组的比值均在0.5~2之间,试验组与菌液对照组的比值均在0.5~2之间;在进行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:该方法可消除林可霉素利多卡因凝胶的抑菌作用,可用于林可霉素利多卡因凝胶的微生物限度检查。
Objective：To explore a suitable method for elimination of the antimicrobial activity of lincomycin hydrochloride and lidocaine hydrochloride gel.Methods：According to the appendices volume Ⅳ of Chinese Pharmacopeia（edition 2015）,barium chloride was added into lincomycin hydrochloride and lidocaine hydrochloride gel to destroy the gel.Membrane-filter method was used in suitability test of microbial limit method.Results：The ratio between diluent group and microorganism solution group in 3 preparations were between 0.5 and 2.The ratio between test group and microorganism solution group were between 0.5 and 2.In the control bacteria tests,the control bacteria was found in the test group.Conclusion：The established method can eliminate the antimicrobial in lincomycin hydrochloride and lidocaine hydrochloride gel and can be used for microbial limit test.
作者
刘冬玲
李芳
冯震
张芝华
刘浩
LIU Dong-ling;LI Fang;FENG Zhen;ZHANG Zhi-hua;LIU Hao(Shanghai Institute for Food and Drug Control, Shanghai 201203, China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2018年第5期838-843,共6页
Chinese Journal of Pharmaceutical Analysis
关键词
林可霉素利多卡因凝胶
微生物限度
破胶
薄膜过滤法
方法学验证
lincomycin hydrochloride and lidocaine hydrochloride gel
microbial limit
gel breaking
membrane filtration method
methodology validation
