多方法结合建立不同剂型医院外用制剂的微生物限度方法学及适用性评价  

Establishment of the microbial limit methodology and applicability evaluation of different dosage forms for hospital external preparations by combining multiple methods

作　　者：陈晓双 刘义 宋毅[1] 金朝辉[1] CHEN Xiaoshuang;LIU Yi;SONG Yi;JIN Zhaohui(Department of Pharmacy,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,China;Sichuan Institute for Drug Control,Sichuan Testing Center of Medical Devices,Chengdu,Sichuan 611731,China)

机构地区：[1]四川大学华西医院临床药学部,四川成都610041 [2]四川省药品检验研究院、四川省医疗器械检测中心,四川成都611731

出　　处：《安徽医药》2025年第4期840-844,共5页Anhui Medical and Pharmaceutical Journal

摘　　要：目的建立医疗机构制剂倍他米松尿素乳膏和松馏油氧化锌软膏微生物限度及控制菌检查方法,并对比其不同基质对方法选择的差异性,填补该院内制剂微生物限度方法学的空白。方法该研究起止时间为2023年9—12月,根据制剂本身的理化性质及标准,松馏油氧化锌软膏为特殊的油脂性基质,倍他米松尿素乳膏为水包油乳剂型基质,均需筛选适宜的中和剂使样品溶解或均匀分散,采用常规法、薄膜过滤法和稀释法等对其进行微生物限度及控制菌的方法学综合研究。结果制剂松馏油氧化锌软膏结果显示,需氧菌、霉菌和酵母菌的计数均无法直接采用常规倾注法,而使用薄膜过滤法,回收率可达到0.8~1.5,满足药典规定的0.5~2.0的回收范围,而倍他米松尿素软膏采用倾注法即可以满足回收要求。而控制菌检查中金黄色葡萄球菌和铜绿假单胞菌均需采用培养基稀释法(1000 mL)。结论根据制剂性质不同,多方法共同建立了医院制剂松馏油氧化锌软膏和倍他米松尿素乳膏的微生物限度检查方法,且进行方法适用性验证,适用性良好,保证检验结果的准确性。Objective To establish a method for the examination of microbial limits and control bacteria in Betamethasone urea cream and zinc oxide ointment,and to compare the difference of different substrates in the selection of methods,so as to fill the gap in the methodology of microbial limits for our hospital preparations.Methods This study was conducted from September to December 2023.According to the physicochemical properties and standards of preparations,the zinc-oxide ointment was a special oil matrix,and the betamethasone urea cream was an oil-in-water emulsion matrix.Suitable neutralizer should be screened to dissolve or disperse the samples.The microbial limit and the controlling bacteria method were studied through conventional method,membrane filtration method and dilution method.Results The results of hospital preparation zinc oxide ointment showed that the count of aerobic bacteria,mold and yeast could not be directly matched by conventional pouring method,but the recovery rate of 0.8~1.5 could meet the recovery range of 0.5~2.0 in pharmacopoeia by using membrane filtration method.However,the recovery rate of betamethasone urea ointment could meet the requirements by conventional method.For Staphylococcus aureus and Pseudomonas aeruginosa,medium dilution method(1000mL)should be selected.Conclusion According to the different properties of hospital preparations,the microbial limit test methods of zinc oxide ointment and betamethasone urea cream are jointly established,and the applicability of the methods are verified,and the accuracy of the test results are ensured.

关 键 词：外用药 微生物限度检查 常规法 薄膜过滤法 中和剂 

分 类 号：R28[医药卫生—中药学]