四种含抑菌成分外用制剂微生物限度检查方法验证  

Validation of microbial limit test methods for four kinds of external preparations with antibacterial ingredients

作　　者：倪玉佳 汤露 戈煜 董文燊 瞿发林 NI Yu-jia;TANG Lu;GE Yu;DONG Wen-shen;QU Fa-lin(Medical Engineering Department,the 904th Hospital of the Joint Logistics Support Force,PLA,Changzhou 213000,Jiangsu,China)

机构地区：[1]解放军联勤保障部队第九〇四医院医学工程科

出　　处：《东南国防医药》2020年第1期52-55,共4页Military Medical Journal of Southeast China

基　　金：2017年常州市第四十二批科技计划(应用基础研究)指导性项目(2017326)

摘　　要：目的建立四种含抑菌成分外用制剂微生物限度的检查方法。方法按《中国药典》2015年版四部的要求,四种含抑菌成分外用制剂(醋酸氯己定洗剂、复方樟脑搽剂、含酚炉甘石涂剂及复方硝酸咪康唑软膏)皆采用薄膜过滤法进行方法适用性试验。结果醋酸氯己定洗剂、复方樟脑搽剂、含酚炉甘石涂剂及复方硝酸咪康唑软膏的需氧菌总数、霉菌酵母菌总数均可利用薄膜过滤法,且各菌的回收率均在0.5~2.0之间。复方硝酸咪康唑软膏采用常规法进行铜绿假单胞菌检查,其他三种制剂则需利用薄膜过滤法进行铜绿假单胞菌与金黄色葡萄球菌的试验。结论所建的微生物限度检查的方法可用作该四种含抑菌成分外用制剂的质量监控。Objective To establish a method for microbial limit test of four kinds of external preparations with antibacterial ingredients.Methods According to the 2015-edition Chinese Pharmacopoeia,membrane filtration method was used for Chlorhexi⁃dine Acetate Pigment,Compound Camphor Liniment,Phenolic Calamine Pigment and Compound Miconazole Nitrate Ointment to do the method applicability test.Results Chlorhexidine Acetate Pigment,Compound Camphor Liniment,Phenolic Calamine Pig⁃ment,Compound Miconazole Nitrate Ointment could use the membrane filtration method for microorganism counts.The recoveries of each validation strain for the total aerobic microbial count,total yeasts and mold count were among 0.5-2.0.At the same time,Com⁃pound Miconazole Nitrate Ointment need use the conventional method to test Pseudomonas aeruginosa.And the other three prepara⁃tions can be determined by membrane filtration methods to test Pseudomonas aeruginosa and Staphylococcus aureus.Conclusion The method verification showed that the microbial limit test can be used for the quality control of four varieties of external preparations.

关 键 词：外用制剂 微生物限度 方法验证 

分 类 号：R286.0[医药卫生—中药学] R927.1[医药卫生—中医学]