呋锌软膏的微生物限度检查适用性考察

Applicability Test of Microbial Limit Test for Fuxin Ointment

目的:建立呋锌软膏微生物限度检查方法。方法:根据《中国药典(2020版)》通则1105、1106、1107具体规则作为检测依据,对供试液的制备方法进行优化选择,采用薄膜过滤加中和剂的方法进行需氧菌总数的测定;采用培养基稀释法进行霉菌和酵母菌总数的测定;采用薄膜过滤法进行金黄色葡萄球菌、铜绿假单胞菌的控制检查。结果:需氧菌总数、霉菌及酵母菌总数实验菌株回收比值均落在0.5~2.0的范围内;金黄色葡萄球菌、铜绿假单胞菌的控制检查试验组和阳性对照组菌株生长良好,阴性对照组和供试品组均无菌株生长。结论:本实验所建立的方法经过方法学验证,符合《中国药典(2020版)》规定,可为医院制剂呋锌软膏质量标准的修订提供科学依据。

Objective:To establish a microbial limit test for Fuxin ointment.Methods:According to the specific rules of general rules 1105,1106 and 1107 in Chinese Pharmacopoeia(2020 Edition),as the detection basis.The preparation methods of the test solution were optimized.The total number of aerobic bacteria was determined by the method of membrane filtration and neutralizer;the total number of mold and yeast was determined by medium dilution method;the control inspection of Staphylococcus aureus and Pseudomonas aeruginosa was carried out by membrane filtration method.Results:The recovery ratio of total aerobic bacteria,mold and yeast were all in the range of 0.5~2.0;the control of Staphylococcus aureus and Pseudomonas aeruginosa grew well in the experimental group and positive control group,but no strain in the negative control group and test group.Conclusion:The method established in this experiment is validated by methodology and conforms to the provisions of Chinese Pharmacopoeia(2020 Edition),which can provide scientific basis for revising the quality standard of furazine ointment.