中国药物评价2025，Vol.42Issue(6)：447-452,6.
国家药品抽检心宁片微生物限度检查与结果分析
Microbial Limit Test and Result Analysis of Xinning Tablets in National Drug Sampling Inspection
常洋涛 1王红红 1张秀慧 1韩斯琴 1任金苹 2海金1
作者信息
- 1. 通辽市市场检验检测中心,内蒙古通辽 028000
- 2. 通辽市第二人民医院,内蒙古通辽 028000
- 折叠
摘要
Abstract
Objective:According to the 2025 national drug sampling inspection plan of the National Medical Products Administration,microbial limit tests were conducted on 75 batches of Xinning Tablets from 5 manufacturers and the results were analyzed.Methods:Based on the relevant provisions of General Chapters 1105 and 1106 of the Chinese Pharmacopoeia 2020 Edition,applicable mi-crobial limit test methods for Xinning Tablets from different manufacturers were established.All the sampled products were tested using the conventional method and the method with additional dilution solution.Results:For the 2025 national drug sampling inspection,all Xinning Tablets from 5 manufacturers could pass the aerobic bacteria limit test using the method with additional dilution solution,and the control bacteria limit test using the conventional method.Four manufacturers' samples could pass the mold and yeast limit test using the conventional method,while the samples from one manufacturer needed to use 1∶20 as the lowest dilution level for the mold and yeast limit test.The microbial limit test results of all 75 batches of Xinning Tablets were in compliance with the regulations.Conclusion:Different manufacturers have different produc-tion processes for Xinning Tablets.When conducting microbial limit tests on drugs,various factors that may affect the test results should be fully considered,and appropriate microbial limit test methods should be established to ensure the safety of drug use for the public.关键词
国家药品抽检/心宁片/微生物限度检查/方法适用性/结果分析Key words
National drug sampling inspection/Xinning tablets/Microbial limit test/Method applicability/Analysis of the results分类
医药卫生引用本文复制引用
常洋涛,王红红,张秀慧,韩斯琴,任金苹,海金..国家药品抽检心宁片微生物限度检查与结果分析[J].中国药物评价,2025,42(6):447-452,6.
