An Introduction to the Standards System and Main Characteristics of Pharmaceutical Excipients in the 2020 Edition of Chinese Pharmacopoeia
CHEN Lei1, SONG Zong-hua1*, HU Shu-jun2, DING Hao3, LI Yi2, YANG Zhao-peng1*
1. Chinese Pharmacopoeia Commission, Beijing 100061, China; 2. Guangdong Institute for Drug Control, Guangzhou 510663, China; 3. Shanghai Food and Drug Packaging Materials Testing Institute, Shanghai 201203, China
Abstract：OBJECTIVE To analyze the general situation of pharmaceutical excipients standard in Chinese Pharmacopoeia 2020 edition and understand the standards accurately. METHODSE This article focuses on the overall information of standard, the changes of working mechanism, the framework of the standard system and the characteristics of all pharmaceutical excipients standards in the 2020 edition of Chinese Pharmacopoeia. RESULTS It has significantly improved that the number of standards, the standard system and the standard formation mechanism of the 2020 edition of China Pharmacopoeia. CONCLUSION The Chinese Pharmacopoeia will continue to strengthen the construction of a standard system for pharmaceutical excipients, promote industrial upgrading and improve supervision efficiency.
陈蕾, 宋宗华, 胡淑君, 丁豪, 李艺, 杨昭鹏. 2020年版《中国药典》药用辅料标准体系及主要特点概述[J]. 中国药学杂志, 2020, 55(14): 1177-1183.
CHEN Lei, SONG Zong-hua, HU Shu-jun, DING Hao, LI Yi, YANG Zhao-peng. An Introduction to the Standards System and Main Characteristics of Pharmaceutical Excipients in the 2020 Edition of Chinese Pharmacopoeia. Chinese Pharmaceutical Journal, 2020, 55(14): 1177-1183.