基于《欧洲药典》与《中国药典》的当归质量控制研究

Study on Quality Control of Danggui(Angelica Sinensis Radix)in <European Pharmacopoeia> and <Chinese Pharmacopoeia>

目的:比较《中国药典》及《欧洲药典》中当归质量控制的标准与方法,根据《欧洲药典》(8.0版)进行不同来源当归质量控制研究。方法:将两部书籍中当归专论的内容从定义、鉴定方法、定量测试等对比其方法和标准的异同。根据《欧洲药典》对国内以及在巴黎市场上购买到的不同批次当归进行显微鉴定、含量测定等质量研究。结果:5批当归药材均符合《欧洲药典》显微及薄层鉴定的质量要求,批次4、5不符合《欧洲药典》中对阿魏酸含量的要求。结论:《欧洲药典》中当归专论研究方法可行性高、稳定性好,国内药材批次质量符合药典标准,巴黎华人街药材质量良莠不齐。

Objective： To compared the criteria and methods of quality control about Danggui （Angelica Sinensis Radix） between 〈Chinese Pharmacopoeia〉 （2010） and 〈European Pharmacopoeia〉 （Edition 8.0）. Meth- ods： The similarities and differences of the methods and standards between 〈European Pharmacopoeia〉 and 〈 Chinese Pharmacopoeia〉 are compared from the definition, identification and quantitative testing. According to 〈European Pharmacopoeia〉, the research of quality control among 5 batches of Angelica Sinensis Radix in- cludes identification and assay was carried. Results： Five batches of medicine plant are all satisfied with the criteria of the identification test, however batch 4 and 5 are not meeting the standards of Ferulic Acid. Con- clusion： The monography about Angelica Sinensis Radix of 〈European Pharmacopoeia〉 has the feasibility and stability. The quality issue of Chinese herb medicine exists in the market of Paris.