微生态活菌制品杂菌检查方法适用性研究及决策方法的建立  

Microbiological examination method suitability study and decision-making method establishment of live microecological products

作　　者：冯丹阳 孟晓丽 沈振 任丽宏 丁勃 FENG Dan-yang;MENG Xiao-li;SHEN Zhen;REN Li-hong;DING Bo(Shandong Institute for Food and Drug Control,Shandong Research Center of Engineering and Technology for Safety Inspection of Food and Drug,Jinan 250101,China;School of Biopharmacy,China Pharmaceutical University,Nanjing 211112,China;School of Pharmaceutical Sciences,Shandong University,Jinan 250012,China)

机构地区：[1]山东省食品药品检验研究院,山东省食品药品安全检测工程技术研究中心,济南250101 [2]中国药科大学生物药物学院,南京211112 [3]山东大学药学院,济南250012

出　　处：《药物分析杂志》2024年第8期1415-1429,共15页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:根据方法适用性试验结果,对微生态活菌制品的杂菌检查方法进行分类,并建立微生态活菌制品杂菌检查决策方法。方法:按《中华人民共和国药典》(简称《中国药典》)四部<通则1105计数方法适用性试验>(简称<通则1105>要求),以大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、铜绿假单胞菌、白色念珠菌和黑曲霉为试验菌,采用胰酪大豆胨琼脂培养基、沙氏葡萄糖琼脂培养基、孟加拉红琼脂培养基、玫瑰红钠琼脂培养基,对已上市微生态活菌制品进行杂菌检查方法适用性试验。结果:成分为厌氧菌或生长特性与试验菌差别较大微生物的制品,可参照《中国药典》四部<通则1105>进行方法适用性试验;成分中含有芽孢杆菌和肠球菌的制品,真菌计数可参照《中国药典》四部<通则1105>进行方法适用性试验;受成分菌的影响,非致病性杂菌无法通过方法适用性试验的产品,可采用选择性培养基对革兰阴性杆菌进行控制;无法通过计数方法适用性试验的制品,可根据给药途径、用药人群等,基于风险评估后,控制部分有潜在危害的微生物。结论:本研究为微生态活菌制品的杂菌检查方法提供了选择依据,进一步补充完善了微生态活菌制品的质量标准体系。Objective:To classify the microbiological examination methods of live microecological products according to the results of suitability test for the enumeration method,and establish the decision-making method for microbiological examination of live microecological products.Methods:The suitability test of the microbiological examination method of live microecological products was performed according to the requirements of the General Chapter 1105 in the Chinese Pharmacopoeia VolⅣ.Escherichia coli,Staphylococcus aureus,Bacillus subtilis,Pseudomonas aeruginosa,Candida albicans and Aspergillus niger were used as the test strains.Tryptic Soy Agar,Sabouraud Dextrose Agar,Rose Bengal Agar and Rose Bengal AgarⅡwere used as medium.Results:For live microecological products composed of anaerobic bacteria or microorganisms with growth characteristics significantly different from the test strains,the suitability test for the method could be performed according to General Chapter 1105.For live microecological products containing Bacillus and enterococcus,the suitability test for the fungal enumeration method could be performed according to General Chapter 1105.Live microecological products could not be tested for suitability of the method due to the influence of the component microorganisms,gram-negative bacteria could be controlled using selective medium.In addition,some potentially harmful microorganisms could be controlled based on risk assessment according to the route of administration and the population of drug users.Conclusion:This study provides a basis for the selection of the microbiological examination methods for live microecological products,and further complements and improves the quality standard system of live microecological products.

关 键 词：生物制品 微生态活菌制品 微生物污染控制 杂菌检查 方法适用性试验 

分 类 号：R917[医药卫生—药物分析学]