摘要
目的:建立复方黄连油涂剂的无菌检查方法。方法:根据《中国药典》2015年版四部无菌检查法的规定,采用薄膜过滤法对该品种进行无菌方法适用性试验。本方法采用了42 ℃无菌十四烷酸异丙酯使供试品充分溶解分散,并加入0.1%无菌蛋白胨水溶液200 mL充分萃取,静置后取下层水相作为供试品溶液。结果:该验证试验中各菌株与阳性对照菌生长同步,而阴性对照组无菌生长。结论:采用该方法对复方黄连油涂剂进行无菌检查,方法可行、有效。
Objective:To establish a standard for the sterility test of Compound Coptis oil coating.Methods:According to the provisions of Chinese Pharmacopoeia(2015 Edition),the membrane filtration method was used to test the applicability of aseptic method.In this method,sterile isopropyl tetradecanoate at 42℃was used to make the test sample fully dissolved and dispersed,and 200 mL of 0.1%sterile peptone water solution was added for full extraction.After standing,the lower water phase was taken as the test solution.Results:The growth of strains synchronized with the bacteria in positive control in the verification test and there was no bacterium growth in negative control.Conclusion:The method for the sterility test of the Compound Coptis oil coating is feasible and effective.
作者
鄢雷娜
王绎
陈希
刘卫德
储梅君
刘绪平
YAN Leina;WANG Yi;CHEN Xi;LIU Weide;CHU Meijun;LIU Xuping(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Quality Evalution of Traditional Chinese Patent Medicine,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Nanchang 330029,China;Guoke Health Holdings(Jiangxi)Co.,Ltd,Nanchang 330029,China)
出处
《药品评价》
CAS
2020年第14期50-52,共3页
Drug Evaluation
基金
江西省药品监督管理局科研项目(2019JS30
2017YX05)。
关键词
复方黄连油涂剂
无菌检查
方法适用性
Compound Coptis Oil Coating
Sterility Test
Applicability Test
