双柏消肿止痛膏微生物限度检查的方法学验证

Validation of Microbial Limit Test Method of Shuangbai Xiaozhong Zhitong Ointment

目的建立双柏消肿止痛膏的微生物限度检查方法。方法按照2020年版《中国药典》四部通则1105、1106、1107中非无菌产品微生物限度检查的规定,对双柏消肿止痛膏微生物限度检查进行方法学验证,采用平皿常规法及不同比例的培养基稀释法测定需氧菌总数、霉菌和酵母菌总数,常规法检查控制菌,计算各试验菌的回收率。结果选取平皿常规法测定需氧菌、霉菌和酵母菌总数,试验菌的回收率均低于0.5;采用培养基稀释法中比例为1∶200测定需氧菌总数、1∶50测定霉菌和酵母菌总数能消除药物的抑菌活性,各试验菌的回收率均在0.5~2.0范围内,采用常规法可检测出控制菌。结论采用培养基稀释法比例为1∶200测定需氧菌总数、1∶50测定霉菌和酵母菌总数,常规法测定控制菌,所确立的双柏消肿止痛膏的微生物限度检查方法,准确可靠,可行性强。

Objective To establish a microbial limit test method for Shuangbai Xiaozhong Zhitong ointment.Methods According to the 2020 edition of Chinese Pharmacopoeia four general principles of the 1105,1106,1107,requirements for microbiological limit testing of non-sterile products,to verify the method of microbial limit testof Shuangbai Xiaozhong Zhitong ointment,using the plate routine method and different proportions of culture medium dilution method to determine total aerobic bacteria,mould and yeast,conventional method to check control bacterium,calculate the recovery rate of each test bacteria.Results The total number of aerobic bacteria,mould and yeasts was determined by plate routine method,and the recoveries were all lower than 0.5.Using the ratio of 1∶200 to determine the total number of aerobic bacteria and 1∶50 to determine the total number of mold and yeast in the medium dilution method can eliminate the antibacterial activity of the drug.The recovery rate of all test strains is in the range of 0.5-2.0,and the control bacteria can be detected by the conventional method.Conclusion Using the dilution method of culture medium 1∶200 to determine the total number of aerobic bacteria,1:50 to determine the total number of mold and yeast,routine method to determine the control of bacteria,the established shuangbai Xiaozhong Zhitong ointment microbial limit examination method,accurate and reliable,strong feasibility.