摘要
目的统一建立4个企业养阴清肺丸微生物限度方法适用性试验。方法依据《中国药典》2015年版四部通则1105、1106对养阴清肺丸中微生物计数法及控制菌检查法进行适用性试验。结果4个企业养阴清肺丸需氧菌、霉菌及酵母菌总数计数方法适用性试验回收比值均在0.5~2.0,控制菌检查均能检出阳性菌。结论4个企业养阴清肺丸需氧菌、霉菌及酵母菌总数计数法及控制菌检查法均可按常规法检查,从而统一了4个企业养阴清肺丸微生物限度检查方法适用性试验。
Objective To unified establish the applicability test of microbial limit test method for Yangyin Qingfei Pills of four companies.Methods According to the Chinese Pharmacopoeia 2015 edition of four general principles of the 1105,1106 for Yangyin Qingfei Pills applicability test was carried out by microorganism counting method and control bacteria inspection method.Results Four companies keep Yangyin Qingfei Pills total number of aerobe mold and yeast count method applicability test total recovery ratio was between 0.5-2.0,the control bacteria test could detect positive bacteria.Conclusion The total count method and control bacteria examination method of aerobic bacteria,mold and yeast in Yangyin Qingfei Pills of four companies can be checked according to the conventional method,thus unifying the applicability test of microbial limit test method for Yangyin Qingfei Pills of four companies.
作者
王静
张秀花
任仲丽
盛春雷
闫世生
WANG Jing;ZHANG Xiu-hua;REN Zhong-li;SHENG Chun-lei;YAN Shi-sheng(Heze Institute for Food and Drug Control,Shandong Province,Heze274000,China)
出处
《中国当代医药》
2020年第36期29-32,共4页
China Modern Medicine
关键词
养阴清肺丸
微生物限度检查
控制菌检查
回收比
方法适用性试验
Yangyin Qingfei Pills
Microbial limit test
Control bacteria examination
Recycling ratio
Method applicability test
