瑞他莫林软膏的微生物限度检查适用性试验

发布时间：2018-01-15 16:34

本文关键词：瑞他莫林软膏的微生物限度检查适用性试验　出处：《中国现代应用药学》2016年05期 　论文类型：期刊论文

【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 a microbiological limit test method for Ritamurin ointment and to test its applicability. Methods the method was dissolved with isopropyl 14 alkanoate. According to the 2015 edition of Chinese Pharmacopoeia, 4th general rules 1105 and 1106 were used to test the applicability of the microbial limit test of Ritamurin ointment. The total number of aerobic bacteria was counted. The total number of fungi and yeast was filtered by thin film after reducing the sampling amount, and the emulsifier polysorbate 80 was added to the washing liquid of water phase. The culture medium dilution method was used to control the bacteria. Results the total number of aerobic bacteria was counted. The recovery ratio of the total count of fungi and yeasts was within 0.5 ~ 2; No Staphylococcus aureus and Pseudomonas aeruginosa were detected in the applicability test of control bacteria. Conclusion Ritamorin ointment has strong bacteriostasis and special matrix according to the Chinese Pharmacopoeia 2015 edition. The method established in this study can be used as a microbiological limit test method for Ratamurin ointment.
【作者单位】：浙江省食品药品检验研究院;
【分类号】：R927.1
【正文快照】： 瑞他莫林是一种半合成的短截北风菌素类抗菌药物,其软膏主要用于治疗金黄色葡萄球菌和化脓链球菌感染的疱疹病[1]。该软膏具有较强的抑菌性,且由较特殊的辅料基质组成,目前尚无确切的微生物限度检查方法。本研究根据该品种的特殊性质建立了微生物限度检查方法,并按照中国药典2

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