不同剂型通宣理肺丸微生物限度检查与结果分析  

Microbial Limit Test and Result Analysis of Tongxuan Lifei Pills of Different Dosage Forms

作　　者：周春峰 宋国良 赵菲 张秀花 ZHOU Chun-Feng;SONG Guo-Liang;ZHAO Fei;ZHANG Xiu-Hua(Heze Institute of Food and Drug Inspection and Testing,Heze 274000,China;Heze city peony district market Supervision and Administration Bureau,Heze 274000,China)

机构地区：[1]菏泽市食品药品检验检测研究院,山东菏泽274000 [2]菏泽市牡丹区市场监督管理局,山东菏泽274000

出　　处：《中国药物经济学》2024年第7期93-96,共4页China Journal of Pharmaceutical Economics

摘　　要：目的通过对全国9家生产企业50批样品进行微生物限度检查,分析不同剂型微生物污染状况。方法按照《中华人民共和国药典》2020版四部通则1105、1106的要求,采用常规法和稀释法进行方法适用性试验,并将检查结果进行分析。结果大蜜丸中需氧菌总数检出率为17.1%,霉菌和酵母菌总数检出率为20.0%;水蜜丸和浓缩丸需氧菌总数、霉菌和酵母菌总数检出率为0。结论大蜜丸微生物污染程度相对较高。Objective To analyze the microbial contamination status of different dosage forms through the microbial limit test results of 50 batches of samples from 9 manufacturers in China.Methods According to the requirements of General Rules 1105 and 1106 of the fourth part of the 2020 edition of Chinese Pharmacopoeia,the applicability test of the method was carried out by conventional method and dilution method,and the test results were analyzed.Results The total number of aerobic bacteria and the total number of mold and yeast in Dami pills were 17.1%,20.0%.The detection rate of the total number of aerobic bacteria,mold and yeast in water-honey pill and concentrated pill were 0.Conclusion The degree of microbial contamination in Dami pills is relatively high.

关 键 词：通宣理肺丸 剂型 污染状况 大蜜丸 检出率 

分 类 号：R286.0[医药卫生—中药学]