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作 者:麻银林 贺学锋 勾洋梅 孔丽亚 山琳 Ma Yinlin;He Xuefeng;Gou Yangmei;Kong Liya;Shan Lin(Examination and Verification Center of Gansu Provincial Drug Administration,Lanzhou 730000,China;Lanzhou Biological Pharmaceutical Co.,Ltd.,Lanzhou 730000,China)
机构地区:[1]甘肃省药品监督管理局审核查验中心,兰州730000 [2]国药集团兰州生物制药有限公司,兰州730000
出 处:《中国药事》2024年第12期1404-1412,共9页Chinese Pharmaceutical Affairs
基 金:甘肃省药品监督管理局药品监管科学研究项目(编号2023GSMPA018)。
摘 要:目的:旨在分析从人血浆中提取人凝血酶原复合物(Prothrombin Complex Concentrate,PCC)及合并血浆生产其他血液制品过程中可能存在的质量风险,为相关企业和监管部门提供风险提示和控制措施建议,以保障公众用药安全。方法:通过文献调研与实际工作经验,分析人血浆提取PCC及合并血浆制造血液制品的工艺流程及质量控制措施,评估PCC工艺过程对人血白蛋白与免疫球蛋白的安全性及有效性影响。重点从工艺参数、人员、设备、文件及法规等角度,比较从人血浆直接制造人血白蛋白、静注人免疫球蛋白与提取PCC后合并血浆制造的工艺差异,并进行风险分析,提出控制措施。结果与结论:PCC制备工艺的选择、原料特性的把握及质量控制,以及关键工艺参数的优化和管理,对PCC及其提取后合并血浆生产的其他血液制品的质量至关重要。通过对PCC制备工艺、原料特性研究及工艺变更风险的分析,提出了风险提示和相关建议,供企业与监管部门参考。Objective:To analyze the potential quality risks in extracting human Prothrombin Complex Concentrate(PCC)from human plasma and producing other blood products,providing risk warnings and control measures to relevant enterprises and regulatory authorities to ensure public drug safety.Methods:Through a comprehensive review of literature and practical experience,the production process and quality control of PCC extraction from human plasma,along with its combination with plasma to manufacture other blood products,were analyzed.The safety and efficacy of producing human serum albumin(HSA)and intravenous immunoglobulin(IG)through the PCC process were also assessed.Additionally,the study compared the risks associated with switching from the direct production of HSA and IG to a process involving PCC extraction and its combination with plasma from the perspectives of process parameters,personnel,equipment,documents,and regulations.Based on this analysis,control measures were proposed.Results and Conclusion:The preparation process,raw material selection,and quality control of PCC,particularly the optimization of key process parameters,are crucial for the quality of both PCC and subsequent plasma-derived products.This study provides risk warnings and relevant recommendations for enterprises and regulatory authorities to refer to through the analysis of PCC preparation process,raw material characteristics and process change risk.
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