中药注射剂的现代化——注射用灯盏花素的研究与开发

Modernization of Traditional Chinese Medicine Injection-R&D of Breviscapine Injection

本文对中药注射剂的研究与开发进行了综述,强调传统中药的给药途径主要是口服或外用,无注射使用的先例。为保证用药安全,中药注射剂必须使用现代科技,先分离有效的先导化合物作为注射剂的原料或对先导化合物进行结构修饰,以解决药物的水溶性、有效性和安全性,并按新药注册审批办法进行全面系统的研究。本文以注射用灯盏花素作为实例进行介绍。

The R＆D of traditional Chinese medicine （TCM） injection was reviewed in this article. The main administration routes of TCM are oral or external administration. But few injections have been applied. To ensure medication safety, modem technologies are required in the manufacture of TCM injections. Lead compounds should be purified or structural modified to improve the water solubility, efficacy and safety. Comprehensive and systematic studies should also be conducted according to measures for the administration of drug registration. The abovementioned topics were reviewed. And examples of R＆D of breviseapine injection were also given in this article.