新癀片微生物限度检查方法适用性研究  

Study on the Applicability of Microbial Limit Test Method for Xinhuang Tablets

作　　者：曹鲁娜 王静 李怀伟 任颖慧 CAO Luna;WANG Jing;LI Huaiwei;REN Yinghui(Heze Institute for Food and Drug Control,Shandong Heze 274032,China)

机构地区：[1]菏泽市食品药品检验检测研究院,山东菏泽274032

出　　处：《中国医药导刊》2022年第5期508-512,共5页Chinese Journal of Medicinal Guide

摘　　要：目的:建立新癀片的微生物限度检查方法。方法:按照《中华人民共和国药典》2020年版四部通则1105、1106、1107对新癀片开展微生物限度检查方法适用性研究。结果:新癀片对金黄色葡萄球菌、枯草芽孢杆菌有抑菌活性,采用1∶100供试液时,需氧菌总数计数方法成立;霉菌和酵母菌总数计数可采用平皿倾注法(1∶10);控制菌检查中金黄色葡萄球菌采用培养基稀释法(500 mL),其余采用常规检查法。控制菌检查采用常规检查法时,大肠埃希菌、耐胆盐革兰阴性菌、沙门菌和铜绿假单胞杆菌阳性对照组生长良好,金黄色葡萄球菌阳性对照组无菌落生长,上述5种控制菌的供试品组和阴性对照组均无菌落生长;采用培养基稀释法(500 mL)时,金黄色葡萄球菌阳性对照组生长良好,供试品组和阴性对照组无菌落生长。结论:本研究建立的方法有效可行,可用于新癀片微生物限度检查。Objective:To establish a method for microbial limit test of Xinhuang tablets.Methods:According to the general requirencet 1105,1106,1107 in Chinese Pharmacopoeia(2020 edition)volume IV,to study the applicability of microbial limit test method for Xinhuang tablets.Results:Xinhuang tablet has bacteriostatic activity against Staphylococcus aureus and Bacillus subtilis.When 1∶100 test solution is used,the method for total aerobic miczobial count is applicable.The total count of molds and yeasts can use the plate pouring method(1∶10).The culture medium dilution method(500 mL)was applicable to detect staphycococcus aureus,and the routine method was applicable to detect the rest.Escherichia coli,Bile-Tolerant Gram-negative Bacteria,Salmonella and Pseudomonas aeruginosa grew well in the positive control group,Staphylococcus aureus did not grow in the positive control group,and no colony grew in the test group and negative control group of the above five control bacteria;When the medium dilution method(500 mL)was used,Staphylococcus aureus grew well in the positive control group,and the test group and the negative control group did not grow.Conclusion:The established method is effective and feasible,and can be used for the microbial limit test of Xinhuang tablets.

关 键 词：新癀片 微生物限度 平皿倾注法 培养基稀释法 方法适用性 

分 类 号：R927.33[医药卫生—药学]