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

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.