林可霉素利多卡因凝胶微生物检验中和剂的选择及方法适用性  

Selection of Neutralizer and Applicability of Method for Microbiological Examination of Lincomycin Lidocaine Gel

作　　者：牟建平 滕宝霞 顾海燕 朱玲 MU Jian-ping;TENG Bao-xia;GU Hai-yan;ZHU Ling(Gansu Institute for Drug Control,Lanzhou 730060,China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730060

出　　处：《海峡药学》2021年第8期43-46,共4页Strait Pharmaceutical Journal

基　　金：国家药典委员会2019年国家药品标准提高课题(课题编号:2019H047)。

摘　　要：目的建立林可霉素利多卡因凝胶微生物限度检查方法,最佳中和剂的筛选。方法按照《中国药典》2015年版四部通则1105、1106、和1107进行微生物限度方法学适用性实验,考察不同中和剂对薄膜过滤的影响,选择最佳的中和剂,采用常规法、稀释法、加入中和剂薄膜过滤法考察林可霉素利多卡因凝胶对阳性菌的回收率;结果霉菌和酵母菌总数采用常规法,回收率在50%~200%之间;需氧菌总数采用薄膜过滤法,回收率在50%~200%之间;控制菌(金黄色葡萄球菌和铜绿假单胞菌)采用薄膜过滤法,可检出阳性菌。结论林可霉素利多卡因凝胶的微生物检查方法为需氧菌总数采用薄膜过滤法(加中和剂10%MgCl_(2)10 mL)检查,霉菌和酵母菌总数采用常规法检查,控制菌采用薄膜过滤法(加中和剂10%MgCl_(2)10 mL)检查。OBJECTIVE To establish a method for microbial limit test of lincomycin lidocaine gel and to screen the best neutralizer.METHODS According to the four general rules 1105,1106 and 1107 of Chinese Pharmacopoeia,the applicability of microbial limit methodology was tested.The recovery rate of lincomycin lidocaine gel on positive bacteria was investigated by routine method,dilution method and adding neutralizer membrane filtration method,and the effect of different neutralizer on membrane filtration was investigated,and the best neutralizer was selected.RESULTS The total number of mold and yeast was between 50%and 200%,the total number of aerobic bacteria was between 50%and 200%,and the total number of aerobic bacteria was between 50%and 200%.The control bacteria(Staphylococcus aureus and Pseudomonas aeruginosa)were treated by membrane filtration.Positive bacteria can be detected.CONCLUSION The microbiological examination method of lincomycin lidocaine gel is that the total number of aerobic bacteria is examined by membrane filtration method(plus neutralizer 10%MgCl_(2)10 mL),and the total number of molds and yeasts is examined by routine method.The control bacteria were examined by membrane filtration(adding neutralizer 10%MgCl_(2)10 mL).

关 键 词：林可霉素利多卡因凝胶 微生物检查 中和剂 氯化镁 薄膜过滤 

分 类 号：R927[医药卫生—药学]