四草克银凝胶的微生物限度检查方法  

Microbial Limit Test Method of Sicao Keyin Gel

作　　者：田勋 连天雁 凌旺 胡海峰[1,2] TIAN Xun;LIAN Tianyan;LING Wang;HU Haifeng(Shanghai Institute of Pharmaceutical Industry,China State Institute of Pharmaceutical Industry,Shanghai 201203;Sinopharm Health Industry Institute Co.,Ltd.,Shanghai 201203;Shanghai Skin Disease Hospital,Shanghai 200443;Zhejiang University of Technology,Hangzhou 310014)

机构地区：[1]中国医药工业研究总院上海医药工业研究院,上海201203 [2]国药集团健康产业研究院有限公司,上海201203 [3]上海市皮肤病医院,上海200443 [4]浙江工业大学,浙江杭州310014

出　　处：《中国医药工业杂志》2020年第5期637-640,共4页Chinese Journal of Pharmaceuticals

摘　　要：建立了四草克银凝胶的微生物限度检查法,并按照《中华人民共和国药典》2015年版(ChP 2015)四部通则微生物限度检查法对其进行验证,采用灭菌的Tween-80和大豆卵磷脂作为中和剂制备供试液,以回收率进行评价。结果显示适用性试验中需氧菌总数、霉菌和酵母菌总数的回收率均在50%~200%,控制菌生长良好,符合ChP 2015的规定,因此可用中和剂法对四草克银凝胶进行微生物限度检查。The microbial limit test method for Sicao Keyin gel was established in this study, and it was verified in accordance with the microbiological limit inspection method in volumn 4 of Chinese Pharmacopoeia 2015 Edition(ChP 2015). The test solution was prepared with sterilized Tween-80 and soybean lecithin as neutralizer, and evaluated by the recovery rate. The results showed that the recovery rate of the total number of aerobic bacteria, molds and the total number of yeasts in the suitability test was 50%-200%. The control bacteria grew well and could meet the requirements of ChP 2015. Therefore, the neutralizer method could be used in microbial limit test of Sicao Keyin gel.

关 键 词：四草克银凝胶 微生物限度检查 方法适用性试验 中和剂 

分 类 号：R286[医药卫生—中药学]