瑞他莫林软膏的微生物限度检查适用性试验

Applicability Test of Microbial Limit Test for Retapamulin Ointment

关键词:  瑞他莫林  微生物限度检查  适用性试验  薄膜过滤法

Key words:  retapamulin  microbial limit test  applicability test  membrane filtration

摘要:

目的 建立瑞他莫林软膏的微生物限度检查方法，并进行适用性实验。方法 用十四烷酸异丙酯溶解后，按照中国药典2015年版第四部通则1105和1106对瑞他莫林软膏进行微生物限度检查适用性实验。需氧菌总数计数、真菌和酵母菌总数计数采用降低取样量后薄膜过滤，并在水相冲洗液中加入乳化剂聚山梨酯80，控制菌检查采用培养基稀释法。结果 需氧菌总数计数、真菌和酵母菌总数计数适用性实验中的回收率比值均在0.5~2内；控制菌检查适用性实验中未检出金黄色葡萄球菌，检出铜绿假单胞菌。结论 瑞他莫林软膏具有较强的抑菌性且基质特殊，按照中国药典2015年版规定，本试验建立的方法可作为瑞他莫林软膏的微生物限度检查方法。

Abstract:

OBJECTIVE To establish and verify a method for the microbial limit test of Retapamulin ointment. METHODS The applicability test for Retapamulin ointment was conducted according to the microbial limit test in the general rules 1105 and 1106 of Chinese Pharmacopoeia (2015 Edition) Vol Ⅴ. Retapamulin ointment was dissolved with isopropyl myristate, and then filtrated by membran. After filtration, total count of aerobic bacteria, total count of molds and yeasts with reducing the amount of sample and adding Tween-80 in aqueous washing solution, the culture medium dilution method was used for control microorganisms test. RESULTS The recovery ratios of applicability test of total count of aerobic bacteria and total count of molds were in the range of 0.5-2. Staphylococcus aureus was not detected and Pseudomonas aeruginosa was detected in the applicability test of control microorganisms test. CONCLUSION In accordance with the provisions of Chinese Pharmacopoeia (2015 Edition), this method can be applied for the microbial limit test of Retapamulin ointment control.