西瓜霜润喉片微生物限度检查方法的建立  

Establishment of Microbial Limit Test Method for Xiguashuang Runhou Tablet

作　　者：曹鲁娜 毕言锋 王静 郑兆显 CAO Lu-na;BI Yan-feng;WANG Jing;ZHENG Zhao-xian(Heze Institute for Food and Drug Control,Heze 274032,China)

机构地区：[1]菏泽市食品药品检验检测研究院,菏泽274032

出　　处：《中国合理用药探索》2022年第5期108-112,共5页Chinese Journal of Rational Drug Use

摘　　要：目的:建立西瓜霜润喉片的微生物限度检查方法。方法:按照《中国药典》2020年版四部要求,采用平皿倾注法(1∶10,1∶50,1∶100)、中和法进行微生物计数方法适用性试验,通过计算回收比值筛选检查方法。结果:西瓜霜润喉片的需氧菌总数计数采用中和法、霉菌和酵母菌总数计数采用平皿倾注法(1∶10)时,各试验菌回收比值均在0.5~2范围内;控制菌检查中除沙门菌采用培养基稀释法外,其他检查项目均采用常规培养基体积。结论:本研究确定的方法准确可行,重现性好,可用于西瓜霜润喉片的微生物限度检查。Objective:To establish a method for microbial limit test of Xiguashuang Runhou tablet.Methods:According to the requirements of Chinese Pharmacopoeia(2020 edition),the applicability test of microbial counting methods was carried out by plate pouring method(1∶10,1∶50,1∶100)and neutralization method,and the inspection methods were screened through calculation of recovery ratio.Results:When the total number of aerobic bacteria of Xiguashuang Runhou tablet was counted by neutralization method,and the mold and yeast count was counted by plate pouring method(1∶10),the recovery ratio of each test bacteria was in the range of 0.5~2.In the examination of control bacteria,except for salmonella by medium dilution method,conventional medium volume was used for other examination items.Conclusion:The method is accurate,feasible and reproducible,and can be used for the microbial limit test of Xiguashuang Runhou tablets.

关 键 词：西瓜霜润喉片 微生物限度 平皿倾注法 中和法 培养基稀释法 

分 类 号：R927.1[医药卫生—药学]