历版《中华人民共和国药典》酊剂制剂通则与中药酊剂相关问题的分析及探讨  

Analysis and discussion on the general rules of tincture preparation and related problems of tincture of Chinese medicine in Pharmacopoeia of the People's Republic of China

作　　者：朱荣玥 蔡梦如 付婷婷 胡雪凌 王开心 尹东阁 胡盼祥 杨玉畅 黄华婷 尹兴斌[1,2] 倪健 ZHU Rongyue;CAI Mengru;FU Tingting;HU Xueling;WANG Kaixin;YIN Dongge;HU Panxiang;YANG Yuchang;HUANG Huating;YIN Xingbin;NI Jian(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Engineering Research Center for Pharmaceutics of Chinese Materia Medica and New Drug Development,Ministry of Education,Beijing 100029,China;Beijing Institute for Drug Control,NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine),Beijing 100022,China)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]中药制药与新药开发教育部工程研究中心,北京100029 [3]北京市药品检验研究院国家药品监督管理局中成药质量评价重点实验室,北京100022

出　　处：《中华中医药杂志》2024年第1期417-424,共8页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：北京市自然科学基金项目(No.7202121);中央高校基本科研业务费专项资金项目(No.2020-JYB-ZDGG-046);中华中医药学会青年人才托举工程项目(No.2021-QNRC2-A03)。

摘　　要：《中华人民共和国药典》(以下简称《中国药典》)是国家药品标准的重要组成部分,其颁布实施对保障药品质量、维护公众健康、促进医药产业发展有着深远的影响。酊剂是中药剂型中重要的组成部分,自1953年起就被药典收录,常用于止痛、健脾益胃等。本研究围绕《中国药典》中酊剂的相关规定进行了整理分析,比较历版《中国药典》中酊剂通则的变化,汇总了从1953年版至2020年版被《中国药典》收录过的26种中药酊剂,从品种、浓度规定、注意事项等方面进行分析比较,探讨其变化及存在的问题;围绕2020年版《中国药典》收录的13种中药酊剂品种,整理分析各品种在不同版本《中国药典》中规定的异同点,从处方及制法、鉴别及含量测定、检查项等方面探讨其变化及发展,分析问题并提出可行性建议,以期为2025年版《中国药典》中药酊剂相关规定的完善提供借鉴和参考。The Pharmacopoeia of the People's Republic of China Chinese Pharmacopoeia(Chinese Pharmacopoeia for short)is an important part of the national drug standards,and its promulgation and implementation have a far-reaching impact on safeguarding drug quality and public health and promoting the development of the pharmaceutical industry.Tincture,an important part of traditional Chinese medicine formulations,has been included in pharmacopoeia since 1953 and are often used to relieve pain and strengthen the spleen and stomach.This study summarized and analyzed the relevant provisions of tincture in the Chinese Pharmacopoeia,compared the changes in the general rules of tincture in the Chinese Pharmacopoeia,summarized 26 kinds of tinctures of traditional Chinese medicine that had been included in the pharmacopoeia since 1953,and discussed the changes and existing problems from the aspects of variety,concentration regulations,precautions and so on.Based on the 13 tinctures of traditional Chinese medicine included in the 2020 edition of Chinese Pharmacopoeia,this paper sorted out and analyzed the similarities and differences of each variety in different versions of pharmacopoeia,discussed their changes and development from the aspects of prescription and preparation method,identification,content determination and inspection items,analyzed the problems and put forward feasible suggestion,so as to provide references for the 2025 edition of Chinese Pharmacopoeia Chinese tincture related provisions of the improvement.

关 键 词：《中华人民共和国药典》 中药酊剂 制剂通则 品种 主治 标准与规定 

分 类 号：R288[医药卫生—中药学]