3种医院软膏剂微生物限度检查方法学研究.pdfVIP

2 0 1 4 年 6 月 第 4 卷 第 1 2 期 ·药品鉴定· 3种医院软膏剂微生物限度检查方法学研究 陈  媛    吴  楣    蓝红梅    宋增炫    彭云英 广东省梅州市食品药品监督检验所，广东梅州 514071 [摘要] 目的 建立氯达软膏、利唑软膏、硫磺软膏医院软膏剂微生物限度检查方法。 方法 按《中国药典》 2010 年版二部微生物限度检查法中对细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证。 结果 氯达软 膏和利唑软膏细菌、霉菌及酵母菌计数检查采用薄膜过滤法，控制菌检查均采用薄膜过滤法；硫磺软膏细菌、 霉菌及酵母菌计数检查采用培养基稀释法，控制菌金黄色葡萄球菌检查采用培养基稀释法，铜绿假单胞菌检 查采用常规法。 结论 医院软膏制剂必须通过方法验证试验建立合理的检验方法，以保证检验结果的准确性。 [关键词] 微生物限度；方法验证；回收率； 医院制剂；软膏 [中图分类号] R927      [文献标识码] B      [文章编号] 2095-0616（2014）12-105-03 Methodological validation for microbial limit test of three kinds of hospital ointment preparation CHEN  Yuan    WU  Mei    LAN  Hongmei    SONG  Zengxuan    PENG  Yunying Meizhou Institute for Food and Drug Control, Meizhou 504071, China [Abstract] Objective To establish the methodological validation for microbial limit tests hospital ointment preparations, such as chlorine ointment, azole ointment and sulfur ointment. Methods According to the microbial limit test in 2010 edition of China Pharmacopoeia, this paper setted the methodological validation for the counting methods of bacteria, mold and yeast and the controlling bacteria checking methods. Results Membrane filtration method could be used in the counting test of bacteria mold and yeast for chlorine ointment and azole ointment, and also this method was used in the controlling bacteria checking. For the sulfur ointment, media dilution method could be used in the counting test of bacteria mold and yeast, and also this method was used in the controlling bacteria checking of staphylococcus aureus, and the routine method was used in the pseudomonas aeruginosa checking. Conclusion To ensure the accuracy of test results, it must be established checking methods for the hospital ointment preparations based on the methodological validation.