七味苦参软膏微生物限度检查法的建立  

Establishment of Microbial Limit Test Method for Qiwei Kushen Ointment

作　　者：彭亚楠 张天武 王晓妃 陈晗 俞涛 鲁双喜 姜俊玲 PENG Yanan;ZHANG Tianwu;WANG Xiaofei;CHEN Han;YU Tao;LU Shuangxi;JIANG Junling(Puer Hospital of Traditional Chinese Medicine,Pu er 66500,China;Puer Drug Inspection and Testing Center,Pu er 66500,China)

机构地区：[1]普洱市中医医院,云南普洱665000 [2]普洱市药品检验检测中心,云南普洱665000

出　　处：《中国民族民间医药》2025年第2期31-35,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：全国中药特色技术传承人才培训项目(国中医药人教函[2023]96号)。

摘　　要：目的:建立七味苦参软膏微生物限度检查法。方法:根据2020年版《中国药典》(四部)通则1105非无菌产品微生物限度检查中的微生物计数法,通则1106非无菌产品微生物限度检查中的控制菌检查法和通则1107非无菌药品微生物限度标准,进行方法适用性试验。结果:采用平皿倾注法测定需氧菌总数、霉菌和酵母菌总数,5种试验菌株的回收率比值均在0.5~2范围内。控制菌检查法采用培养基稀释法,进行金黄色葡萄球菌、铜绿假单胞菌的检查。结论:该方法可作为七味苦参软膏微生物限度的检查方法。Objective To establish method of microbial limits test for Qiwei Kushen ointment.Method The applicability of the method was tested according to the microbial counting method in the microbial limit test for non sterile products in General Rule 1105,the control bacteria test method of the microbial limit test for non sterile products in General Rule 1106,and the microbial limit standard for non sterile drugs in General Rule 1107 in 2020 edition of the Chinese Pharmacopoeia(Part 4).Results The total number of aerobic bacteria,mold,and yeast were measured by using plate pouring method,and the results showed that the recovery ratios of five experimental strains were all in the range of 0.5-2.Staphylococcus aureus and Pseudomonas aeruginosa of control bacteria were detected by medium dilution method(100 mL TSB).Conclusions This method is simple,feasible,accurate,and reliable,and can be used to check the microbial limits of Qiwei Kushen ointment.

关 键 词：七味苦参软膏 微生物限度 平皿倾注法 稀释法 

分 类 号：R284.1[医药卫生—中药学]