非无菌药品微生物检查能力验证质量控制分析  

Quality control analysis of validation of non sterile drug microbiological examination capability

作　　者：陆今成 田树兴 鲁朝德 周崇富 LU Jincheng;TIAN Shuxing;LU Chaode;ZHOU Chongfu(TCM formula granule engineering research center of yunnan province,Chuxiong Yunnan,675000,China;Yunnan Shineway Spirin Pharmaceutical Co.,Ltd.)

机构地区：[1]云南省中药配方颗粒工程研究中心,云南楚雄675000 [2]云南神威施普瑞药业有限公司

出　　处：《质量安全与检验检测》2024年第5期59-63,共5页QUALITY SAFETY INSPECTION AND TESTING

基　　金：基于标准汤剂的云南省特色中药配方颗粒生产工艺、质量体系及等效性研究(202102AA310027);云南省配方颗粒重点实验室项目(202105AG070014)。

摘　　要：通过对非无菌药品微生物检查的能力验证,加强企业微生物实验室的质量控制,提高微生物检验检测技术能力。依据《中国药典》2020年版四部通则1105非无菌产品微生物限度检查:微生物计数法中平皿法(倾注法)、《中国药典》2020年版四部通则1106非无菌产品微生物限度检查:控制菌检查法和非无菌药品微生物检查能力验证作业指导书进行检查。结果显示,样品236需氧菌总数为1.7×10^(3) CFU/mL,样品316霉菌和酵母菌总数为9.5×10^(2) CFU/mL,样品321金黄色葡萄球菌和铜绿假单胞菌定性均为阴性;能力验证样品结果满意,且质量过程可控。实验室具备非无菌药品微生物检验的技术能力,能够保证检测结果的数据准确、可靠。Through the ability to verify the microbial inspection of non-sterile drugs,strengthen the quality control of enterprise microbiology laboratory and improve the technical ability of microbial inspection and detection.Microbial limit test for non-sterile products was conducted according to the Chinese Pharmacopoeia 2020 Edition of General Rule 1105:Microbe counting method in the plate method(Pour method),Chinese Pharmacopoeia 2020 edition of General Rule 1106 for Non-sterile products Microbial Limit Test:Control bacteria test method and non-sterile drug microbial test ability verification operating instructions.The results showed that the total number of aerobic bacteria in sample 236 is 1.7×10^(3) CFU/mL,the total number of mold and yeast in sample 316 is 9.5×10^(2) CFU/mL,sample 321 Staphylococcus aureus and Pseudomonas aeruginosa were negative qualitatively;The results of the proficiency test sample are satisfactory,and the quality process is controllable.The testing laboratory has the technical capability of microbiological examination of non-sterile drugs to ensure the accuracy and reliability of test results.

关 键 词：能力验证 非无菌药品 需氧菌总数 霉菌和酵母菌总数 金黄色葡萄球菌和铜绿假单胞菌定性 

分 类 号：R446.5[医药卫生—诊断学]