不同国家(地区)党参药材质量标准比较  

A comparison of the quality standards of Codonopsis pilosula in different countries(regions)

作　　者：刘晓慧 何文静[3] 关人通 唐卓诗 马剑华[1] 李文[2] 张映华[4] Liu Xiaohui;He Wenjing;Guan Rentong;Tang Zhuoshi;Ma Jianhua;Li Wen;Zhang Yinghua(School of Public Health,Lanzhou University,Lanzhou 730000,China;School of Pharmacy,Lanzhou University,Lanzhou 730000,China;Institute of Traditional Chinese Medicine,Xinjiang Medical University,Urumqi 830017,China;Department of Infection Management,Gansu Provincal Hospital,Lanzhou 730000,China)

机构地区：[1]兰州大学公共卫生学院,甘肃兰州730000 [2]兰州大学药学院,甘肃兰州730000 [3]新疆医科大学中药学院,新疆乌鲁木齐830017 [4]甘肃省人民医院感染管理科,甘肃兰州730000

出　　处：《兰州大学学报（医学版）》2024年第4期20-28,共9页Journal of Lanzhou University（Medical Sciences）

基　　金：甘肃省自然科学基金资助项目(23JRRA1303);甘肃省技术创新引导计划资助项目(22CX2NK004);国家药监局中药材及饮片质量控制重点实验室科研资助项目(2023GSMPA-KL13);甘肃省科技专员专项基金资助项目(22CX8GA008);甘肃省药品监督管理局科研基金资助项目(2022GSMPA0012);甘肃省中医药科研课题资助项目(GZKP-2021-38)。

摘　　要：目的 通过比较不同国家(地区)党参药材质量标准,为中国党参药材质量标准提升研究提供依据。方法 分析比较现行2020年版《中华人民共和国药典》、第18版《日本药局方》、第11.0版《欧洲药典》、《香港中药材标准》、第9版《中华药典》和第12版《韩国药典》中党参药材的质量标准要求。结果 各药典对党参基原、性状、鉴别、含量测定、检查项、中药饮片等各检测项均有差异。结论 中国党参质量标准有待完善,建议中国药典党参药材增加党参、素花党参和川党参3个种的记载,以及党参指纹图谱、含量测定、农药残留、重金属、中药饮片方面的检测项。Objective Many countries and regions have pharmacopoeia standards for Codonopsis pilosula,but there are some differences between their quality standards.The objective here was to improve the measuring method of pharmacopoeia standards and quality standards and provide a basis for the study of Codonopsis pilosula quality standards.Method Analyses and comparisons were made of the quality standards required for Codonopsis pilosula in diverse pharmacopoeias,including the 2020 edition of the Pharmacopoeia of the People's Republic of China,the 18th edition of Japanese Pharmacopoeia,the 11.0 edition of European Pharma-copoeia,Hong Kong Standard for Chinese Medicinal Materials,the ninth edition of Chinese Pharmacopoeia and the 12th edition of Korean Pharmacopoeia.Results Variations were found across pharmacopoeias regard-ing the standards of each test item of Codonopsis pilosula,including the basal principle,traits,identification,content determination,check items,and traditional Chinese medicine tablets.Conclusion The quality stan-dards of Codonopsis pilosula in the Pharmacopoeia of the People's Republic of China needs to be improved.It is suggested that the three kinds of Codonopsis pilosula in the Chinese pharmacopoeia should be recorded separately,and the detection items of Codonopsis pilosula fingerprint,content determination,pesticide resi-dues,heavy metals and Chinese herbal decoction pieces should be added.

关 键 词：不同国家(地区) 药典 党参 质量标准 

分 类 号：R921[医药卫生—药学]