【作者】 项晓娟；

【导师】 全红；

【作者基本信息】 黑龙江中医药大学 ， 药剂学， 2005， 硕士

【摘要】 中药国际化已经成为中药发展的必然趋势,它的实现需要完成许多工作。对于药品的安全性、有效性、可控性这三个基本特性,“安全性”首先要得到保证。然而长久以来,安全性评价却成为了制约中药走向世界的关卡,如何规范我国药物的安全性评价工作已成为整个药学界的当务之急。中药的安全性问题密切联系着中药走向世界,为全人类健康事业做出更大贡献的目标。 本文从对中药国际化发展战略、药物非临床研究质量管理规范(GLP)的研究入手,分析二者的密切联系,从“安全性评价”角度展开论述,指出GLP建设中存在的不足,提出相应的改进建议和措施,以此来完善我国GLP建设及其他相关工作,加速我国中药国际化的进程。更多还原

【Abstract】 Internationalization is the inevitable trend of the development of Chinese herbal medicine, which needs to do many things. Among the three fundamental features of medicine, i.e., safety, validity, and controllability, "safety" must be assured firstly. But safety estimating has been the obstacle of international procedure of Chinese herbal medicine. As a result, standardizing safety estimation has become the most important task for the whole medicine field to solve. Safety is a pivot relating the Chinese medicine to the whole world, and is the problem that must be solved on the way devoting to the health of the whole mankind.This thesis studies the internationalizing strategy of Chinese herbal medicine, Good Laboratory Practice(GLP), and their relationship; points out the defect of GLP; and proposes some necessary suggestion and effective measures to improve it , which will undoubtedly accelerate the internationalizing process of Chinese medicine.更多还原