药品中霉菌和酵母菌总数计数能力验证结果与分析  

Analysis of verification results of detection ability of total mold and yeast count of drugs

作　　者：孙乃霞 郭社民 SUN Naixia;GUO Shemin(Puyang Institute for Food and Drug Control&Puyang Key Laboratory of Drug Safety Research and Evaluation,Puyang Henan,457005,China)

机构地区：[1]濮阳市食品药品检验检测中心&濮阳市药品安全研究与评价重点实验室,河南濮阳457005

出　　处：《质量安全与检验检测》2024年第2期35-37,共3页QUALITY SAFETY INSPECTION AND TESTING

摘　　要：为分析药品中霉菌和酵母菌总数计数能力验证结果,提高实验室检测霉菌和酵母菌的能力,本文依照NIFDC-PT-446能力验证作业指导书,及《中国药典》2020年版四部通则1105非无菌产品微生物限度检查中微生物计数法,测定2份样品的霉菌与酵母菌总数。结果显示,2份样品的|Z|均小于2,为满意结果。表明本实验室具有药品中霉菌和酵母菌总数计数的检测能力。In order to analyze the validation results of the total count of mold and yeast in drugs and improve the laboratory's ability to detect mold and yeast,this article determined the total count of mold and yeast in two samples in accordance with the NIFDC-PT-446 Capability Validation Operation Guide and the Microbial Counting Method in the Microbial Limit Inspection of Non Sterile Products in Part Four of the 2020 edition of the Chinese Pharmacopoeia.The results show that the|Z|of both samples are less than 2,indicating satisfactory results.This indicates that our laboratory has the ability to detect the total count of mold and yeast in drugs.

关 键 词：药品 霉菌与酵母菌总数计数 能力验证 

分 类 号：R446.5[医药卫生—诊断学]