肤宁洗剂微生物限度检查方法的建立及验证

正肤宁洗剂是由黄柏、白鲜皮、白芷、地肤子等中药制成的复方制剂,具有清热燥湿、祛风止痒的功效,用于急性皮炎、湿疹伴有渗出或脓性分泌物等治疗。按照其用药途径,根据2015年版《中国药典》(四部)~(1])相关规定,微生物限度检查应进行需氧菌、霉菌和酵母菌总数的测定,及金黄色葡萄球菌、铜绿假单

Establishment and Verification of Microbial Limit Test Method for Funing Lotion

Objective To establish and verify the inspection method of microbial limit of Funing lotion. Methods According to the Chinese Pharmacopia(2015)of Examination method of microbial limit, the plate, medium dilution and membrane filtration methods were used for counting aerobic bacteria and mold and yeast. Methods for checking control bacteria (Staphylococcus aureus and Pseudomonas aeruginosa) were veried too. Result According to the recovery experiment, the plate method and medium dilution method were less than 0.5 in recovery test rates, However, the membrane filtration method could be reached in the range from 0.5 to 2. Conclusion Membrane filtration method can be applied to not only aerobic bacteria, mold and yeast inspection , but also controling bacteria. The inhibition effect can be eliminated by the membrane filtration, and it is applicabled to microbial limit test method for Funing lotion.