四种医院制剂微生物限度检查方法学验证.PDFVIP

中国药事 2015 年 5 月 第 29 卷 第 5 期 485 四种医院制剂微生物限度检查方法学验证 严晓明，刘萌，朱燕 （广东省韶关市食品药品检验所，韶关 512026） 摘要 目的：建立复方雷琐辛涂剂、氯霉素酊、痤疮洗面乳液、硫代硫酸钠溶液 4 种医院制剂的微生物 限度检查方法，控制药品质量。方法：依据《中国药典》2010 年版二部附录中微生物限度检查法，分别 对样品进行 5 种菌株的回收率试验和控制菌检查方法验证。结果：在适宜的供试品配制条件下，分别选 用薄膜过滤法和培养基稀释法消除制剂的抑菌作用，大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白 色念珠菌、黑曲霉 5 种试验菌回收率均高于 70%，控制菌均能正常检出。结论：复方雷琐辛涂剂、氯霉素酊、 痤疮洗面乳液需要用薄膜过滤法进行质量控制，而硫代硫酸钠溶液可用培养基稀释法进行检查，所建立 的方法准确、可靠、重现性好。 关键词： 医院制剂；雷琐辛涂剂；氯霉素酊；痤疮洗面乳液；硫代硫酸钠溶液；微生物限度；方法验证 中图分类号：R95 文献标识码：A 文章编号： 1002-7777(2015)05-0485-07 doi ：10. 16153/j. 1002-7777. 2015. 05. 008 Methodological Validation of Microbial Limit Test in Four Kinds of Hospital Preparations Yan Xiaoming, Liu Meng, Zhu Yan (Shaoguan Institute for Drug and Food Control, Shaoguan 512026, China) Abstract Objective: To control the quality of drugs, establish microbial limit test methods for four hospital preparations: resorcinol paint, chloramphenicol tincture, acne cleansing emulsion and Sodium thiosulfate solution. Methods: The recovery test of five bacterial strains and the methodological validation of controlled bacteria were done on the basis of the microbial limit test methods in the appendix of Chinese Pharmacopoeia II, 2010 edition. Results: The recovery tests of five bacterial strains (Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Candida albicans, Aspergillus niger) were higher than 70% and the controlled bacteria can be detected through membrane-filter procedure or culture medium dilution method in suitable conditions. Conclusion: Resorcinol paint, chloramphenicol tincture and acne cleansing emulsion can be controlled by membrane-filter procedure and Sodium thiosulfate solution can be tested by culture medium dilution method, and the methods are accurate, reliable and reproducible. Keywords: hospital preparations; resorcinol paint; chloramphenicol tincture; acne cleansing emulsion; sodium thiosulfate solution; mic