《中国药典》2015年版四部增修订概况

摘要

《中国药典》2015年版一个重要变化是将原药典中药、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。新版《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。新版《中国药典》四部在制剂通则的规范、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 changes of the Chinese Pharmacopoeia ( ChP) 2015 is the development of the ChP 2015 volumeⅣfirstly based on the integrating the appendices of the ChP volumeⅠ(traditional Chinese medicine),Ⅱ(chemical drugs) andⅣ(biologics), including the general requirements for preparations, testing methods, guidelines as well as the excipients standards.The ChP 2015 volumeⅣ, as the general requirements, is much important parts of ChP.It has taken a great progress for the ChP 2015 volumeⅣon regulating the general requirements for preparation, improving the testing methods, the advantage analysis technology application, strengthening the process quality control, establishing the control system on the excipients as well as the excipients monographs adoption.It will play more important role on improving the standards overall level of ChP, strengthening the quality control for the drugs and assuring the quality of the drugs.