摘要
多组分生化药因来源复杂、物质基础不明,部分品种临床应用中不良反应率较高而被录入国家重点监控药品目录。虽然其不良反应多涉及过敏样反应,但是目前对多组分生化药的过敏性研究甚少,尚未形成完善的过敏性研究评估体系。故本文通过对多组分生化药的特点及近年来国内外复杂机制类药物过敏性研究相关文献进行分析,阐述了适用于多组分生化药的过敏与类过敏评价策略;并从体内外2个方面对于过敏性研究的手段和技术方法进行分析和汇总,以期为多组分生化药的临床应用、安全性研究及生产工艺优化提供参考和依据。
The multi-component biochemical drugs are listed in the national key monitoring drugs catalogue because of their complex sources, unknown material basis and high adverse reactions in clinical application of some varieties. Although the adverse reactions are mostly related to anaphylactic reactions, at present, there are few studies on the anaphylaxis of multicomponent biochemical drugs, and a complete evaluation system of anaphylactic research has not been formed. Therefore, based on the analysis of the characteristics of multi-component biochemical drugs and the related literature on the allergy research of complex mechanism drugs at home and abroad in recent years, this paper expounds the allergy and pseudoallergy evaluation strategies applicable to multi-component biochemical drugs, and analyzes and summarizes the means and technical methods of allergy research from both in vivo and in vitro, with a view to the clinical application and safety of multi-component biochemical drugs research and production process optimization to provide reference and basis.
作者
吴殷囡
汪玉馨
杨奇涛
徐鹏
张思琦
宗卫峰
孟长虹
史清水
陆益红
WU Yinnan;WANG Yuxin;YANG Qitao;XU Peng;ZHANG Siqi;ZONG Weifeng;MENG Changhong;SHI Qingshui;LU Yihong(Department of Pharmaceutical Analysis,Xuzhou Medical University,Xuzhou 221004,China;Jiangsu Institute for Food and Drug Control,Nanjing 210009,China;China Pharmaceutical University,Nanjing 210009,China)
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2021年第10期1257-1262,共6页
Chinese Journal of Modern Applied Pharmacy
基金
江苏省实验动物协会科研课题(DWXH201902)
大学生创新创业训练计划项目(202010316085S)。
关键词
多组分生化药
过敏反应
评价策略
multi-component biochemical drugs
allergic reaction
evaluation strategy
作者简介
吴殷囡,女,硕士生,Tel:18252157209,E-mail:wynmrcx@163.com;通信作者:汪玉馨,女,博士,副主任药师,Tel:(025)86251278,E-mail:wyx_carrie@163.com;通信作者:陆益红,女,博士,主任药师,Tel:(025)86251220,E-mail:yihonglu@163.com。
