5种中药口服液微生物限度检查方法的探索与思考

Exploration and thinking of microbial limit test methods for five kinds of traditional Chinese medicine oral liquid

探索和建立5种中药口服液微生物限度检查方法。依据《中华人民共和国药典》2020年版四部通则1105、1106及1107中的方法,对5种中药口服液中微生物计数及控制菌的检查方法进行验证。结果显示,麻杏甘草口服液、五根汤口服液、补血催乳口服液的需氧菌总数检查宜采用平皿法,而荆防解感口服液、银芦感冒口服液对试验菌枯草芽孢杆菌有抑制作用,故需氧菌总数检查宜采用薄膜过滤法;5种口服液均宜采用常规平皿法进行霉菌与酵母菌总数检查,大肠埃希菌检查宜采用常规法。微生物计数法检查中试验组所加的5种试验菌回收比值(R)均为0.5≤R≤2.0;大肠埃希菌检查中试验组均能检出所加试验菌相应的反应特征。本研究所建立的微生物限度检查方法准确可靠,但荆防解感口服液、银芦感冒口服液因对试验菌株中的枯草芽孢杆菌有抑制作用,需使用成本较高且操作烦琐的薄膜过滤法,如果只用铜绿假单胞菌、金黄色葡萄球菌、黑曲霉菌和白色念珠菌4种有致病性的试验菌株进行方法验证,则荆防解感口服液和银芦感冒口服液的检查方法均可使用简单易操作的平皿法。故有必要探索符合中药制剂特点的微生物限度检查指导原则。

The objective was to explore and establish the microbial limit test methods for five kinds of traditional Chinese medicine oral liquids.According to the methods in the general principles 1105,1106 and 1107 of the fourth part of the 2020 edition of the Chinese Pharmacopoeia,the inspection methods of the microbial count and the control bacteria in five kinds of traditional Chinese medicine oral liquids were verified.The total number of aerobic bacteria in Maxing Gancao oral liquid,Wugentang oral liquid and Buxue Cuiru oral liquid was examined by plate method,Jingfang Jiegan oral liquid and Yinlu Ganmao oral liquid had antibacterial activity against the test strains Bacillus subtilis,so the total number of aerobic bacteria was examined by membrane filtration.The total number of mold and yeast was examined by conventional plate method,and Escherichia coli was detected by conventional method in 5 oral liquid.The recovery ratio of five test bacteria added by the test group in the microbial counting inspection was within the limit of 0.5≤R≤2.0;in the test of Escherichia coli,the test group could detect the corresponding reaction characteristics of the added test bacteria.The microbial limit test method established in this study is accurate and reliable.However,Jingfang Jiegan oral li-quid and Yinlu Ganmao oral liquid can only inhibit Bacillus subtilis in the test strain.In order to eliminate its bacteriostasis,the membrane filtration method with high cost and cumbersome operation must be used.If only four pathogenic experimental strains of Pseudomonas aeruginosa,Staphylococcus aureus,Aspergillus niger and Candida albicans are used for method verification,the examination methods of Jingfang Jiegan oral liquid and Yinlu Ganmao oral liquid can be simple and easy to operate plate method.So it is necessary to explore the guiding principles of microbial limit test in line with the characteristics of traditional Chinese medicine preparations.