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
周春峰 1宋国良 2赵菲 1张秀花1
作者信息
- 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
- 折叠
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.
Abstract
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Key words
Tongxuan Lifei Pills/Dosage form/Pollution status/Dami Wan/Detection rate引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据