医院制剂甲癣涂剂微生物限度检查方法建立及方法适用性研究  

Study on Microbial Limit Test for Hospital Preparation of Onychomycosis

作　　者：蔡素芬[1] 黎金丽 徐晓[1] 黄久遂[1] CAI Su-fen;LI Jin-li;XU Xiao;HUANG Jiu-sui(Guangzhou Institute of Dermatology,Guangzhou 510095,China;Guangzhou Boji Medical Biotechnological Co.Ltd.,Guangzhou 51070,China)

机构地区：[1]广州市皮肤病防治所,广东广州510095 [2]广州博济医药生物技术股份有限公司,广东广州510700

出　　处：《海峡药学》2021年第1期72-75,共4页Strait Pharmaceutical Journal

摘　　要：目的建立医院制剂甲癣涂剂微生物限度检查方法,并对方法进行方法适用性试验,以确认所采用的方法适用于该产品。方法依照《中国药典》2015年版四部通则1105、1106。结果微生物计数法供试液用0.7%硫代硫酸钠溶液中和稀释制成1∶20供试液,采用薄膜过滤法测定人工污染试验菌回收比值,试验组和中和剂对照组回收比值均在0.5^2范围,说明此法能消除供试品的抑菌活性,且中和剂对微生物生长无毒害性,方法适用性良好;控制菌检查接种1∶20供试液20 mL至100 mL胰酪大豆胨液体培养基中,结果检出试验菌,说明方法适用。结论甲癣涂剂微生物限度检查供试品经中和稀释后,微生物计数采用薄膜过滤法测定,控制菌检查接种相当于1 mL供试品于100 mL胰酪大豆胨液体培养基中检查金黄色葡萄球菌和铜绿假单胞菌。OBJECTIVE To establish a microbial limit test method for the hospital preparation for the nail coating,and conduct a suitability test to confirm that the method is suitable.METHODS According to the ChP 2015 VolumeⅣ〈1105〉and〈1106〉.RESULTS Preparing the test solution with 0.7%sodium thiosulfate,the dilution ratio was 1∶20.Determined recovery ratio of artificially contaminated test bacteria with membrance filtration method,and the recovery ratio of artificially contaminated test bacteria was determined by membrane filtration method.The recovery ratio of the experimental group and the diluent control group was in the range of 0.5-2.The results showed that this method could eliminate the bacteriostatic activity of the tested products,and the diluent had no toxicity to microbial growth.The method had good applicability,and the test bacteria inoculated in the test solution 20 mL to 100 mL cheese soybean peptone liquid medium at 1∶20 were detected.The description method was applicable.CONCLUSION Examination of microbial limit of onychomycosis coating after neutralization and dilution,microbial count was determined by membrane filtration method,The inoculation of controlled bacteria was equivalent to the detection of Staphylococcus aureus and Pseudomonas aeruginosa in 100 mL TSB.

关 键 词：含碘医院制剂 微生物限度检查 方法适用性试验 

分 类 号：R927[医药卫生—药学]