名优中成药二次开发的策略与实践——以参芎葡萄糖注射液和安宫牛黄丸为例  

Optimization Strategy and Practices of Chinese Patent Medicine-Shengxiong Glucose Injection and Angong Niuhuang Pill

作　　者：曾河坤 聂红[1,2] Zeng Hekun;Nie Hong(Guangdong Province Key Lab Pharmacodynamic Institute,College of Pharmacy,Jinan University,Guangzhou 510632,China;International Cooperative Laboratory of Traditional Chinese Medicine Modernization and Innovative Drug Development of Chinese Ministry of Education(MOE),School of Pharmacy,Jinan University,Guangzhou 510632,China.)

机构地区：[1]广东省药效物质基础和创新药物研究重点实验室,暨南大学,广州510632 [2]教育部中药现代化与创新药物研究国际联合实验室,暨南大学,广州510632

出　　处：《世界科学技术-中医药现代化》2019年第9期1896-1901,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家自然科学基金委员会项目（81673634）：基于自噬信号通路研究参芎注射液抗MIR及心律失常的分子机制，主持人：聂红

摘　　要：名优中成药二次开发模式通常包含五种导向策略,即临床导向、药理导向、安全导向、质量标准导向和工艺导向。同时,临床上中成药"老药新用"的情况也在不断增多。本文仅以参芎葡萄糖注射液与安宫牛黄丸的二次开发和应用为例,从药理导向、安全导向、扩大适应症等角度出发,对名优中成药上市后再评价的有效性、安全性等相关的药效学与作用机制研究、扩大适应症等几个方面进行探讨,以期对其他名优中成药的二次开发有一定的借鉴和启发。The general optimization mode for Chinese Patent Medicine(CPM)includes 5 directions:clinical-oriented,pharmacological-oriented,safety-oriented,quality control oriented,and manufacturing process oriented.Besides,CPM repurposing in clinic is often and emerging.In this article,we pharmacological research and new indication research,exemplified by our research on Shenxiong Glucose Injection and Angong Niuhuang Pills,from the pharmacological-oriented,safety-oriented and drug repurposing oriented research.

关 键 词：名优中成药二次开发 心脑血管疾病 安宫牛黄丸 参芎葡萄糖注射液 

分 类 号：R285.1[医药卫生—中药学]