生化药注射剂中可见异物分析方法的建立及应用  

Establishment and application of analysis method for visible particles in biochemical injection

作　　者：乔冲[1] 王慧丽 连莹[1] 陈炜[1] 仲平[1] QIAO Chong;WANG Hui-li;LIAN Ying;CHEN Wei;ZHONG Ping(Henan Institute for Food and Drug Control,Zhengzhou 450008)

机构地区：[1]河南省食品药品检验所,郑州450008

出　　处：《药物分析杂志》2020年第9期1599-1611,共13页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:对药液及包装用安瓿分别进行综合性考察,建立了生化药注射剂中可见异物的分析方法,以了解其类型,并为可见异物的控制提供建议。方法:建立了生化药注射剂药液中Si、B、Al含量的测定方法、药液中不溶性物质的显微鉴定方法和以亚甲蓝染色法和电镜观察法相结合的注射剂包装用安瓿内表面侵蚀程度的考察方法,将该分析方法应用于肌苷注射液和骨瓜提取物注射液2个品种,结合pH检查、不溶性微粒检测、灯检法与光散射法相结合的可见异物检测结果,对其可见异物的类型和成因进行确定和分析。结果:肌苷注射液中产生的可见异物与安瓿质量及药液与安瓿相容性的关系更大,应关注内包材的选择和质量;骨瓜提取物注射液中产生的可见异物与药液本身关系更大,应关注药品质量。结论:建立的方法可对生化药注射剂中的可见异物类型进行确定和分析,为生化药注射剂中可见异物的控制提供建议。Objective:The analysis method for visible particles in biochemical injection was established to investigate the interaction between pharmaceutical liquid and the ampoule used for packaging comprehensively,and the suggestion for the control of visible particles was provided.Methods:The determination of Si,B,Al content based on ICP-AES,microscopic identification method of insoluble substance in solution and the inner surface erosion degree of ampoules used for packaging was investigated by methylene blue staining and electron microscopy.The analysis methods are applied in inosine injection and guguatiquwu zhusheye,in combination with the results of pH value examination,invisible particle detection,detection of visible particles by light scattering combined with lamp detection.The sources and types of the visible particles was analyzed.Results:The visible particles produced in inosine injection has a greater relationship with the quality of ampoule,and with the compatibility between pharmaceutical liquid and ampoule.The visible particles in guguatiquwu zhusheye were more related to the the quality of the liquid preparation.Conclusion:The established method can determine and analyze the types of visible particles in biochemical injections.And it could provide suggestions for the control of visible particles in biochemical injections.

关 键 词：生化药注射剂 可见异物 成因分析 肌苷注射液 骨瓜提取物注射液 

分 类 号：R917[医药卫生—药物分析学]