| 引用本文: | 厉高慜,赵宇豪,杨燕,凌今,陈钢,杨美成,邵泓.生物制品无菌制剂污染菌风险及无菌检查法培养条件调查[J].中国现代应用药学,2023,40(6):840-847. |
| LI Gaomina,ZHAO Yuhaoa,YANG Yanb,LING Jina,CHEN Ganga,YANG Meichengb,SHAO Honga.Investigation on the Risk of Contaminating Mircobe in Sterile Preparations of Biologics and the Culture Conditions of Sterility Test[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(6):840-847. |
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| 生物制品无菌制剂污染菌风险及无菌检查法培养条件调查 |
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厉高慜1, 赵宇豪1, 杨燕2, 凌今1, 陈钢1, 杨美成2, 邵泓1
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1.上海市食品药品检验研究院, 国家药品监督管理局治疗类单抗质量控制重点实验室, 上海 201203;2.上海市食品药品检验研究院, 国家药品监督管理局药品微生物检测技术重点实验室, 上海 201203
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| 摘要: |
| 目的 调查中国药典无菌检查法中保留生物制品特殊培养条件的必要性。方法 对全国范围内的生物制品生产企业开展为期2年的产品和高等级洁净区中捕获污染菌种属和频数调查，并对污染菌培养条件进行核实。结果 在生产企业上报的有明确鉴定结果的污染菌中，未发现必须采用硫乙醇酸盐流体培养基低温(20~25 ℃)培养的需求。结论 从培养谱角度，在基于风险的前提下，建议中国药典无菌检查法对生物制品特殊培养要求进行修订。 |
| 关键词: 生物制品 无菌检查法 特殊培养条件 污染菌风险 |
| DOI：10.13748/j.cnki.issn1007-7693.20221999 |
| 分类号:R945 |
| 基金项目:国家药品标准提高课题(2020S06，2021S04)；上海市研发公共服务平台项目(19DZ2294600) |
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| Investigation on the Risk of Contaminating Mircobe in Sterile Preparations of Biologics and the Culture Conditions of Sterility Test |
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LI Gaomina1, ZHAO Yuhaoa1, YANG Yanb2, LING Jina1, CHEN Ganga1, YANG Meichengb2, SHAO Honga1
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1.Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China;2.Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology, Shanghai 201203, China
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| Abstract: |
| OBJECTIVE To investigate the necessity of retaining special culture conditions for biologics in the sterility test of Chinese Pharmacopoei. METHODS To carry out a 2-year investigation on the species and frequency of contaminated microbes captured in products and high-grade clean areas of biologics manufacturers nationwide, and verify the culture conditions of contaminated microbes. RESULTS There was no need to adopt fluid thioglycollate medium for low temperature (20-25℃) culture of contaminated microbes reported by manufacturers with definite identification results. CONCLUSION From the perspective of culture spectrum, it is suggested to revise the requirements of special culture conditions for biologics in the sterility test of Chinese Pharmacopoeia based on risk assessment. |
| Key words: biologics sterility test special culture conditions risk of contaminated microbes |
