2015年版《中国药典》四部增修订概况

Brief Introduction of Chinese Pharmacopoeia 2015 Edition Volume Ⅳ

2015年版《中国药典》一个重要变化是将前版药典中药、化学药、生物制品三部分别收载的附录,包括制剂通则、检验方法和指导原则进行整合,与药用辅料一并单列成卷,作为药典第四部。2015年版《中国药典》四部作为药典标准的共性要求,是药典标准的重要组成部分。2015年版《中国药典》四部在检验方法的完善、先进检测技术的应用、全面质量控制的建立、药用辅料标准体系的完善和品种收载均取得很大进步,对提升药典标准整体水平、加强药品质量控制、提高药品质量发挥重要作用。

The main significant change of the Chinese Pharmacopoeia（ Ch. P） 2015 edition is the development of volume Ⅳ for the first time based on integrating the appendices of the Ch. P volume Ⅰ（ traditional Chinese drug）,Ⅱ（ chemical drugs） and Ⅲ（ biologics）,including the general requirements for preparations,testing methods,guidelines as well as the excipients standards. The Ch.P 2015 volume Ⅳ,as the general requirements,is the most important part of Ch. P. The Ch. P 2015 volume Ⅳ has made a great progress in improving testing methods,application of advanced analysis technology,strengthening process quality control,improving the control system for excipients as well as establishing the excipients monographs. It will play an important role in improving the overall standards of Ch. P,strengthening the drug quality control and assuring the drug quality.