从美国首个批准植物药veregen软膏看我国中药质量控制

Consideration about quality control of Chinese medicine from first botanical drug product approved by America

2006年,美国食品和药物管理局批准了首个植物药veregen软膏。本文结合veregen软膏新药上市申请提供的化学、生产和质量控制资料,结合我国中药质量控制的研究和评价现状,分析veregen软膏的批准对中药质量控制的借鉴作用。

Veregen ointment （veregen） is the first botanical drug approved by Food and Drug Administration （FDA） of America in 2006. Based on the chemistry, manufacturing and control documentation of veregen ointment submitted to the FDA in investigational new drug applications, the paper states the FDA＇s thinking on chemistry, manufacturing and control evaluation of botanical drug product, and its reference to drug development of the quality control of Chinese medicine.