2020年版《中国药典》四部制剂通则增修订及主要特点概述与浅析  

Development and Revision of Dosage Forms General Chapters of Chinese Pharmacopeia 2020 Edition VolumeⅣ

作　　者：尚悦[1] 宋宗华[1] 周建平[2] 杨昭鹏 SHANG Yue;SONG Zong-hua;ZHOU Jian-ping;YANG Zhao-peng(Chinese Pharmacopoeia Commission,Beijing 100061,China;China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]国家药典委员会,北京100061 [2]中国药科大学,南京210009

出　　处：《中国药学杂志》2020年第14期1167-1171,共5页Chinese Pharmaceutical Journal

摘　　要：目的《中国药典》第11版——2020年版已正式出版。通过对2020年版《中国药典》制剂通则标准编制的基本情况及主要变化等进行分析,为进一步引导生产企业全面关注并执行制剂生产质量控制和整体要求提供帮助。方法笔者主要围绕2020年版《中国药典》中制剂通则的系统增修订工作,以及编制内容进行介绍。结果对2020年版《中国药典》制剂通则总体情况分析有助于进一步提高制剂通则整体性、先进性和可读性。结论2020年版《中国药典》制剂通则的完善,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。OBJECTIVE To guide pharmaceutical manufacturing to pay full attention to andimplement the quality control and overall requirements of preparation production based on theanalysis of the revision work and major changes of the Dosage Forms General Chapters of the 2020 edition of the Chinese Pharmacopoeia.METHODSE This article mainly introduces the compilation progress of the Dosage Forms General Chapters of the 2020 edition of the Chinese Pharmacopoeia.RESULTS The analysis is helpful to improve the integrity,advancement and readability of the Dosage Forms General Chapters of the 2020 edition of the Chinese Pharmacopoeia.CONCLUSION The improvement of the Dosage Forms General Chapters of the 2020 edition of the Chinese Pharmacopoeia will play an important role in improving the overall level of Chinese pharmacopoeia standards,strengthening drug quality control and improving drug quality.

关 键 词：中国药典 制剂通则 增修订 

分 类 号：R917[医药卫生—药物分析学]