蛇毒血凝酶质控关键技术研究进展  

Research progress in key technologies for quality control of snake venom hemocoagulase drugs

作　　者：刘博[1,2] 郭云霄 刘莉莎 范慧红[1,2] LIU Bo;GUO Yunxiao;LIU Lisha;FAN Huihong(National Institutes for Food and Drug Control,Beijing 102629,China;NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China;School of Pharmacy,China Pharmaceutical University,Nanjing Jiangsu 210009,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629 [3]中国药科大学药学院,江苏南京210009

出　　处：《中国药物警戒》2023年第10期1195-1200,共6页Chinese Journal of Pharmacovigilance

基　　金：北京市自然科学基金资助项目(7194337)。

摘　　要：近年来,随着蛇毒血凝酶在临床中的广泛应用,对其产品质量的要求也在不断提高。但受限于产品的复杂性以及技术手段的制约,其质控关键技术的发展,尤其是结构表征、纯度分析以及效价测定等质控项目越来越难以满足日趋严格的质控要求。本综述参考了国内外药典和其他蛋白类药物的最新研究进展,对蛇毒血凝酶药物的结构特征、纯度以及效价测定方法进行系统的总结和展望,希望能够对血凝酶类药品质控水平的全面提升提供参考。With the wide application of snake venom hemocoagulase in clinical practice in recent years,better quality of its products is required.However,constrained by the complexity of the products and related technologies,it becomes increasingly difficult for the key quality control technologies,especially quality control projects such as structural characterization,purity analysis and potency,to meet the requirements of increasingly stringent quality control.By referring to domestic and foreign pharmacopoeias and the latest research progress in other proteinic drugs,this article summarizes the structural characteristics,purity and potency determination methods of snake venom hemocoagulase drugs before future developments are predicted.It is hoped that this article can be of referential value for the improvement of levels of quality control of hemocoagulase drugs.

关 键 词：血凝酶 质量控制 一级结构 高级结构 纯度 活性 蛇毒 

分 类 号：R943.3[医药卫生—药剂学] R994.1[医药卫生—药学]