摘要
目的:建立帕司烟肼胶囊的微生物限度检查方法。方法:采用稀释平皿倾注法进行微生物计数及控制菌常规法检查。结果:需氧菌回收率0.8~1.2(符合0.5~2.0标准),霉菌/酵母菌回收率0.8~0.9;大肠埃希菌检测专属性良好(实验组阳性,阴性组无干扰)。结论:该方法操作简便、重复性佳、结果可靠,适用于帕司烟肼胶囊微生物质控。
[Objective]To establish a microbial limit test method for Pasiniazid capsules.[Methods]Microbial counts were performed using the dilution pour plate method,and routine tests for control organisms were conducted.[Results]Recovery rates for aerobic bacteria ranged from 0.8 to 1.2(meeting the 0.5~2.0 standard),while recovery rates for molds/yeasts were 0.8~0.9.The specificity of Escherichia coli detection was validated(positive in the test group,with no interference in the negative control group).[Conclusion]This method is simple,reproducible,and reliable,making it suitable for microbial quality control of Pasiniazid capsules.
作者
杨洁
陈珍珍
蔡萍
王七根
刘晴
YANG Jie;CHEN Zhenzhen;CAI Ping;WANG Qigen;LIU Qing(Jiangxi Provincial Drug Inspector Center,Nanchang 330006,China;Xuanhao Pharmaceutical(Nanchang)Co.,Ltd.,Nanchang 330224,China)
出处
《云南化工》
2026年第1期84-87,共4页
Yunnan Chemical Technology
关键词
帕司烟肼胶囊
微生物限度检查
方法学验证
中国药典
肺结核
药品
Pasiniazid Capsules
Microbial Limit Test
Methodological Validation
Chinese Pharmacopoeia
Tuberculosis
Medicine
