4种抑菌液体制剂微生物限度检查方法学研究及比较  

Methodological research and comparison of microbial limit test for four antibacterial liquid preparations

作　　者：翁静艳 赵柳娅 张平 胡亚英 吕迁洲 李晓宇 WENG Jingyan;ZHAO Liuya;ZHANG Ping;HU Yaying;LYU Qianzhou;LI Xiaoyu(Department of Pharmacy,Zhongshan Hospital Affiliated to Fudan University,Shanghai 200032,China;Shanghai Songjiang Institute for Food and Drug Control,Shanghai 201699,China)

机构地区：[1]复旦大学附属中山医院药剂科,上海200032 [2]上海市松江食品药品检验所,上海201699

出　　处：《中国医院药学杂志》2024年第5期495-499,共5页Chinese Journal of Hospital Pharmacy

基　　金：上海市临床重点专科建设项目(编号:shslczdzk06504)。

摘　　要：目的:建立苯丙林搽剂、复方丙酸氯倍他索搽剂、冰醋酸涂剂、浓复方苯甲酸涂剂4种医院抑菌液体制剂的微生物限度检查方法,控制药品质量。方法:分别采用平皿法、薄膜过滤法消除供试品溶液的抑菌作用,进行需氧菌总数、真菌和酵母菌总数的回收率试验,采用培养基稀释法和薄膜过滤法来进行控制菌的验证。结果:所建立的检查方法对验证菌株的回收率在0.5~2.0,控制菌铜绿假单胞菌及金黄色葡萄球菌可检出,阴性对照组没有检出控制菌。结论:该方法科学可行,结果准确可靠,可以客观反映药物中微生物的污染状况,适用于上述4种液体制剂的微生物限度检查。OBJECTIVE To control the quality of drugs and establish microbial limit test methods for four antibacterial liquid preparations including diphenhydramine hydrochloride,clobetasol propionate and lincomycin hydrochloride liniment,compound clobetasol propionate liniment,glacial acetic acid paint and concentrated compound benzoic acid paint.METHODS The bacteriostatic effect of the tested solution was eliminated by plate method and membrane filtration method,and the recovery tests of the total number of aerobic bacteria,fungi and yeast were carried out.The control bacteria were verified by medium dilution method and membrane filtration method.RESULTS The recoveries of the total aerobic microbial count and the total yeast and mold count for all kinds of testing strains were 0.5-2.0.In the method validations,Pseudomonas aeruginosa and Staphylococcus aureus were detected,and no control bacteria were detected out in the negative control group.CONCLUSION It is proved that the method is scientific and feasible,and the results are accurate and reliable.It is suitable for the quality control of the 4 liquid pharmaceutical preparations,which can objectively reflect the contamination status of microorganisms in drugs.

关 键 词：抑菌液体制剂 微生物限度检查 培养基稀释法 薄膜过滤法 

分 类 号：R927.1[医药卫生—药学]