蒙药五味清浊制剂和藏药石榴健胃制剂的研究进展  

Research Progress on the Wuwei Qingzhuo Preparation of Mongolian Medicine and Shiliu Jianwei Preparation of Zang Medicine

作　　者：戴胜云 吴东雪 黄瑞 刘杰[1] 胡晓茹[1] 肖萌 连超杰[1] 魏锋[1] 郑健[1] 朱嘉亮[1] DAI Shengyun;WU Dongxue;HUANG Rui;LIU Jie;HU Xiaoru;XIAO Meng;LIAN Chaojie;WEI Feng;ZHENG Jian;ZHU Jialiang(Department of Ethnic Medicine,Institute for Control of Chinese Traditional Medicine and Ethnic Medicine,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院中药民族药检定所民族药室,北京102629

出　　处：《医药导报》2025年第1期61-67,共7页Herald of Medicine

基　　金：中国食品药品检定研究院关键技术研究项目(GJJS-2022-7-1);国家药品监督管理局药品监管科学体系建设重点项目“新技术新方法在中药质量控制中的应用”(RS2024Z006-106)。

摘　　要：根据2次国家药品抽查检验结果,梳理蒙药五味清浊制剂与藏药石榴健胃制剂的历史沿革、标准收载情况,生产企业及剂型规格、质量标准研究、药理药效研究及临床应用研究,为提高2个品种的质量标准提供参考。通过文献检索蒙药五味清浊制剂与藏药石榴健胃制剂研究情况,结果显示有关2种制剂的研究非常少,药学实验数据和临床试验数据均不足,但2种制剂是蒙药和藏药中非常重要的制剂,处方和功效基本一致,质量标准却相差很大,不利于二者及其相关剂型的质量控制,建议《中华人民共和国药典》综合考虑这一类情况,对其质量标准进行统一。Based on the results of the National Drug Sampling and Inspection Programme,we summarized the history,the standard collection,the production enterprises and the dosage form specifications,the quality standard study,the pharmacological and pharmacodynamic study,and the clinical application study of Wuwei Qingzhuo preparation of Mongolian medicine and Shiliu Jianwei preparation of Zang medicine,to provide the basis for improved quality standards for both preparations.The development of these two preparations was searched and analyzed through literature.The available information shows that there is very little research on the two preparations and insufficient pharmacological experimental and clinical experimental data.The two preparations are basically the same in prescription and efficacy.However,the quality standards are very different,which are not conducive to the quality control of the two and their related dosage forms.And it is suggested that the Chinese Pharmacopoeia should take the situation of this category into comprehensive consideration,and unify the quality standards of the two preparations.

关 键 词：五味清浊制剂 石榴健胃制剂 国家药品抽检 质量控制 

分 类 号：R286[医药卫生—中药学] R926[医药卫生—中医学]