中国药典丹参质量标准与美、欧、日药典对比分析

Contrastive Analysis on Quality Standards of Salvia Miltiorrhiza Radix Et Rhizoma In Chinese Pharmacopoeia and Pharmacopoeia of the United States,Europe,and Japan

目的:比较《中国药典》(ChP 2015)中丹参与《欧洲药典》(EP8.0)、《美国药典》(USP40)和《日本药典》(JP17)的异同,为中药丹参及其制剂的开发和国际注册提供参考。方法:通过质量标准对比分析,并对灰分、重金属、浸出物、含量等进行比较。结果:《中国药典》中丹参的质量标准比较接近欧美药典,其中美国药典标准更加严格,欧盟和中国药典次之,日本药典稍为宽松。结论:了解《中国药典》中丹参的质量标准与欧盟、美国和日本药典的异同,促进中药丹参及其制剂的开发和国际注册,同时为我国丹参药材的种植、加工等提供参考。

Objective：Compare the quality standards of Miltiorrhiza Radix Et Rhizoma in Chinese Pharmacopoeia （CHP 2015）were compared with those in the European Pharmacopoeia（EPS. 0）, United States Pharmacopeia（USP40）, and Japanese Pharmacopoeia （JP17）, to provide reference for development and international registration of Miltiorrhiza Radix Et Rhizoma. Methods： Contrastive analysis of quality standards, and several main indicators such as content, heavy metals, pesticide residues, and other limits were compared with the other three pharmacopoeias. Results. Chinese Pharmacopoeia in the quality standards of Miltiorrhiza Radix Et Rhizoma is more close to the European and American Pharmacopoeia, which the United States Pharmacopoeia standards more strin- gent, the European Union and Chinese medicine pharmacies followed, the Japanese Pharmacopoeia slightly relaxed. Conclusion .. To understand the similarities and differences of quality standard between the Chinese Pharmacopoeia and the European Union, and the United States, and the Japanese Pharmacopoeia, which is more convenient for the development and international registration of Milt- iorrhiza Radix Et Rhizoma and its preparation. At the same time, it can provide reference for the cultivation and processing of Milti- orrhiza Radix Et Rhizoma