聚山梨酯80对盐酸布替萘芬乳膏微生物限度方法学验证影响的研究  

Research on Effect of Polysorbate 80 on Methodology Validation of Microbial Limit Test for Butenaf ine Hydrochloride Cream

作　　者：裴小捷 韩超 杜凤梅 宋燕 郭芳 

机构地区：[1]山东博士伦福瑞达制药有限公司,山东济南250101 [2]山东福瑞达生物化工有限公司,山东济南250101

出　　处：《食品与药品》2009年第5期31-33,共3页Food and Drug

摘　　要：目的寻找比例合适的稀释剂,提高盐酸布替萘芬乳膏微生物限度方法学验证实验中实验菌的回收率。方法调整稀释剂pH7.0氯化钠-蛋白胨缓冲液中聚山梨酯80的比例,按照中国药典2005年版二部微生物限度检查法检查。结果pH7.0氯化钠-蛋白胨缓冲液含15%聚山梨酯80的实验菌回收率明显高于含5%,10%,20%聚山梨酯80的回收率。结论pH7.0氯化钠-蛋白胨缓冲液含15%聚山梨酯80的实验菌回收率最为适宜。Objective To search the proper percentage of polysorbate 80 to saline in order to improve the recovery of testing bacteria in the methodology validation of microbial limit test for Butenafine Hydrochloride Cream. Methods Adjusting the percentage of polysorbate 80 in pH 7.0 sodium chloride-peptone buffer, the microbial limit test was performed according to the Appendix XI J of Chinese Pharmacopoeia（Edition 2005）. Results The recovery rate of testing bacteria in pH 7.0 sodium chloride-peptone buffer containing 15 % polysorbate 80 was obviously higher than that containing 5 %, 10 %, 20 % polysorbate 80, respectively. Conclusion The pH 7.0 sodium chloride-peptone buffer containing 15 % polysorbate 80 shows the optimal recovery rate of testing bacteria.

关 键 词：聚山梨酯80 盐酸布替萘芬乳膏 微生物限度 方法学验证 

分 类 号：R986[医药卫生—药品]