基于《欧洲药典》和《中华人民共和国药典》中黄芪质量控制的比较研究

Comparison of the quality control of Astragalus mongholicus Radix based on European Pharmacopoeia and Chinese Pharmacopoeia

目的 :对《欧洲药典》和《中华人民共和国药典》中黄芪部分进行比较。方法 :根据《欧洲药典》和《中华人民共和国药典》,对国内和巴黎购买的3批次黄芪饮片进行质量控制。结果 :这3批次饮片均符合《欧洲药典》和《中华人民共和国药典》要求。结论:虽然《中华人民共和国药典》与《欧洲药典》对黄芪的质量控制的要求有一定区别,但是无论是性状鉴别、指标成分的含量,还是安全性检查,《中华人民共和国药典》均不低于《欧洲药典》。

Objective： To compare the quality control of Astragalus mongholicus Radix based on European Pharmacopoeia and Chinese Pharmacopoeia. Methods： The quality control was performed to three batches of Astragalus mongholicus Radix from China and Paris, France based on European Pharmacopoeia and Chinese Pharmacopoeia. Results： The results showed they all met the requirements of both European and Chinese Pharmacopoeias. Conclusion： Although some diferences exist between two Pharmacopoeias, the quality criteria of Chinese Pharmacopoeia for Astragalus mongholicus Radix are not inferior to those of European Pharmacopoeia in the identifcation of characteristics, the content of mark ingredient and safety examination.