微流数字成像技术在蛋白药物制剂不溶性微粒分析中的应用  

Application of Microflow Digital Imaging in Particulate Matter Analysis of Protein Drug Formulations

作　　者：谢力琦 毕宝帅 黄懿 XIE Liqi;BI Baoshuai;HUANG Yi(Shanghai Tanshi Biotech Co.,Ltd.,Shanghai 201206)

机构地区：[1]上海探实生物技术有限公司,上海201206

出　　处：《中国医药工业杂志》2024年第1期36-41,共6页Chinese Journal of Pharmaceuticals

摘　　要：不溶性微粒可以指示注射剂的潜在质量问题和免疫原性风险,是注射剂质量管理中必须评估的质量指标。微流数字成像(MDI)技术是检测不溶性微粒的新方法,相较于不溶性微粒检测“金标准”的光阻法,除了可以提供颗粒的大小和数量信息外,还可以通过高分辨图像获得颗粒种类和形状等特性数据,并且所需样本量少,特别适用于蛋白药物注射剂的质量分析。文章从不溶性微粒的成因和各国药品监管机构和药典对注射剂不溶性微粒质量控制的技术要求出发,综述了MDI技术在蛋白药物处方筛选和工艺研究中的应用进展,以保障蛋白药物制剂的安全性和有效性。Particulate matter can indicate potential quality problems and immunogenic risks of injections,so as to be a necessary indicator for injection evaluation in the quality management.Microflow digital imaging(MDI)is a new technology for detecting particulate matter.Compared with the light obscuration method,which is the"gold standard"for particulate matter analysis,MDI can not only provide the detailed information on the size and quantity of particles,but also obtain the type and shape characteristics through high-resolution images.In addition,MDI requires a small sample volume and is especially suitable for the quality analysis of protein drug injections.From prospects of the formation causes of particulate matter and the technical requirements of drug regulatory agencies and pharmacopoeias in various countries for the quality control of particulate matter in injections,this paper reviews the application progress of MDI technology in formulation development and process research of protein drugs,in order to ensure the safety and efficacy of protein drug formulations.

关 键 词：蛋白药物 注射剂 不溶性微粒 微流数字成像 质量控制 

分 类 号：R917[医药卫生—药物分析学]