中国银杏药品质量标准体系的建立及规范的实践  

Establishment and Practice of Quality Standard System for Chinese Ginkgo Medicinal Products

作　　者：谢德隆 高崎 黄新生 金小吾 

机构地区：[1]上海杏灵科技股份有限公司,上海200127

出　　处：《世界科学技术-中药现代化》2002年第1期61-62,共2页World Science and Technology(Modernization of Traditional Chinese Medicine)

摘　　要：银杏酮酯由银杏叶提取而成,主要质量指标:黄酮醇苷∶黄烷醇∶内酯=12∶10∶3、银杏酸≤5ppm。本文介绍了作者及所在公司为保证用药的安全性和有效性,建立了银杏药品质量标准体系,即按GAP要求建立了银杏叶质量标准;按GMP要求建立了银杏酮酯和杏灵颗粒的质量标准。Ginkgonin (a ginkgo biloba extracts GBE-50) and Xingling Ginkgo Granules are new traditional Chinese herbal drugs approved for marketing by the SDA. GBE-50 is composed of total flavolnoids: flavolnol glycosides: lactones=44:24:6, and ginkgolic acids ≤ 5PPM. The authors have established the quality criteria of Ginkgo leaves according to GAP and those of GBE-50 and Xingling Ginkgo granules according to GMP in their studies. Xingling Ginkgo Granules can be effectively used for chronic stable angina pectoris in coronary heart disease, vertigo, etc. by the experiments of Pharmacodynamics, General Pharmacology and Toxicology as well as clinical Practice. And on this basis a system for the quality of Ginkgo drugs is set up so as to ensure their safety and effects.

关 键 词：质量标准体系 银杏酮酯 GEB50 杏灵颗粒 GAP GMP 

分 类 号：TQ461[化学工程—制药化工]