从我国中药类产品出口角度，研究中药相关标准法规对我国进出口贸易的意义。针对我国中药提取物和中药材出口情况，提出要借助国际标准化组织（International Organization for Standardization，ISO）平台，推进我国中药国际标准的制定工作；完善修订我国药典法规，争取参与国外药典法规的修订；针对中成药出口情况，提出可以借鉴日本汉方药，开展经典名方研究；为防止发达国家利用资金和技术上的优势在传统知识基础上无偿进行二次开发，或进行中药、中成药专利抢注以获取高额利润，提出要谨防我国中草药被生物盗版，及早建立中医药古籍保护制度。

Based on the export situation of Chinese medicine products, this paper studied the significance of standards and regulations of Chinese medicine. China should make good use of the ISO/TC249 platform to improve the work on the international standardization of Chinese medicine. Japanese Kampo afforded lessons for China in studying the ancient classical formulas. We should establish a protection system for Chinese medicine to prevent the biological piracy of Chinese herbal medicine.

R2-03