岩黄连栓微生物限度检查方法的适用性试验  

Applicability test of microbial limit test for Yanhuanglian suppository

作　　者：庞云娟 庞兰英 曾金 刘康连 梁晓玲 龙文洲 肖萍 PANG Yun-juan;PANG Lan-ying;ZENG Jin;LIU Kang-lian;LIANG Xiao-ling;LONG Wen-zhou;XIAO Ping(Yulin Center for Food and Drug Control/Yulin Engineering Technology Research Center for Quality Monitoring and Evaluation of Chinese Medicinal Materials(Including Spices),Yulin537000,Guangxi,China;Liuzhou Maternity and Child Healthcare Hospital,Liuzhou545001,Guangxi,China)

机构地区：[1]玉林市食品药品检验检测中心/玉林市中药材(含香辛料)质量监测与评价工程技术研究中心,广西玉林537000 [2]柳州市妇幼保健院,广西柳州545001

出　　处：《湖北农业科学》2023年第1期162-166,共5页Hubei Agricultural Sciences

基　　金：广西科技厅研发计划项目(桂科AB16380245);广西科技基地和人才专项(桂科AD22080002)。

摘　　要：按照《中国药典》2020年版四部通则1105、1106和1107的要求对岩黄连栓的微生物计数法、控制菌检查法适用性试验研究,比较供试品溶液稀释平皿倾注法和供试品溶液稀释薄膜过滤贴膜法优选需氧菌总数计数方法。结果表明,岩黄连栓需氧菌总数采用1∶200供试品溶液稀释平皿倾注法,霉菌和酵母菌总数采用常规1∶10平皿倾注法,金黄色葡萄球菌(Staphylococcus aureus)检查采用1000 mL增菌液接种法,铜绿假单胞菌(Pseudomonas aeruginosa)检查采用100 mL增菌液接种法,均符合《中国药典》2020年版四部通则的规定,为供试品溶液制备和适用性试验的方法提供参考。According to the requirements of 1105,1106 and 1107 in the fourth part of the Chinese Pharmacopoeia(2020),the applicability of the microbial counting method and control bacteria test for Yanhuanglian suppository was studied.The applicability research experiment in a sequential,scientific and reasonable way was carried out.The method of aerobic bacterial count was optimized by comparing the advantages of the sample solution dilution plate method and sample solution dilution membrane filtration method.The results showed that the total number of aerobic bacteria of Yanhuanglian suppository was determined by the method of dilution plate of sample solution(1∶200),the Staphylococcus aureus test was carried out by dilution method(1000 mL),the Pseudomonas aeruginosa was detected by the routine method(100 mL TSB).The method adopted was in accordance with the relevant provisions of general principles of the fourth part of the Chinese Pharmacopoeia(2020),the reference method of preparation and applicability test of sample solution was provided for the suppository with bacteriostatic action and partial prescription components.

关 键 词：岩黄连栓 医院制剂 适用性试验 微生物计数法 金黄色葡萄球菌(Staphylococcus aureus) 

分 类 号：R927.33[医药卫生—药学]