彝药野拔子药用历史考证与质量控制方法的探索  

Exploration on Medicinal History and Quality Control of Yi Herbal Medicine Elsholtziae Rugulosae Herba

作　　者：林春燕 王楠 任洁 董媛 张雯洁 Lin Chunyan;Wang Nan;Ren Jie;Dong Yuan;Zhang Wenjie(Yunnan Institute for Food and Drug Control,Ministry of Industry and Information Technology Industrial Technology Basic Public Service Platform,Kunming 650000,China)

机构地区：[1]云南省食品药品监督检验研究院工业和信息化部产业技术基础公共服务平台,昆明650000

出　　处：《中国药事》2025年第2期216-226,共11页Chinese Pharmaceutical Affairs

基　　金：国家药品监督管理局药品注册司专项“特色民族药检验方法示范性研究”(野拔子品种)(编号NIFDC-TCM2021-043-MZY005)。

摘　　要：目的:针对目前彝药野拔子质量研究中存在的民族药用历史考证缺乏、质量标准相对简单、数字化程度较低等情况,对其本草考证和质量控制的方法进行探索。方法:首先进行药用历史与本草考证,然后基于收集到的35批次样品,进行性状、鉴别、检查、特征图谱、含量测定项目的研究,建立相应的方法。结果:建立从彝药本草考证到特征图谱的整套野拔子质量研究方法,能够有效控制野拔子的质量,其中建立的特征图谱确证了18个共有峰,对其中5个峰(咖啡酸、木犀草苷、木犀草素-7-O-葡萄糖醛酸苷、迷迭香酸、木犀草苷-3'-O-葡萄糖醛酸苷)进行指认,含量测定项目测定35批次样品中3个较主要活性成分的含量,其中迷迭香酸含量为0.287%~2.639%,木犀草苷-3'-葡萄糖醛酸苷含量0.011%~1.069%,咖啡酸含量0.011%~0.046%。结论:本文建立了一套较完善的彝药质量研究方法,探讨了野拔子质量控制研究中存在的问题与可能的解决方案,能够为今后更多彝药品种的研究提供思路与参考。Objective:To help the current situation of the lack of research on the history of ethnic medicine use,relatively simple quality standards and low degree of digitalization in quality research of Yi Herbal Medicine Elsholtziae Rugulosae Herba,the textual research and quality control methods were explored.Methods:Firstly,the medicinal history and textual research of materia medica were studied,subsequently,based on the collected 35 batches of samples,the characteristics,microscopic identification,examination items,characteristic map and content determination items were studied,and corresponding methods were established.Results:A complete set of quality research methods from herbal research to content determination of Elsholtziae Rugulosae Herba were established,which could effectively control the quality of Elsholtziae Rugulosae Herba.The established HPLC Characteristic Chromatogram confirmed 18 common peaks and identified 5 of them,include caffeic acid,luteolin,luteolin 7-O-β-D-glucuronide,rosmarinic acid and luteolin-3'-glucuronide.The content of 3 main active components in 35 batches of samples was determined,the results of rosmarinic acid content were 0.287%-2.639%,luteolin-3'-glucuronide content were 0.011%-1.069%,caffeic acid content were 0.011%-0.046%.Conclusion:This article has established a complete set of quality research methods of Yi Herbal Medicine,and discuss the problems and possible solutions in quality control of Yi Herbal Medicine by taking Elsholtziae Rugulosae Herba as an example.It could provide ideas and reference for further studies on Yi Herbal Medicine.

关 键 词：彝药 药用历史考证 质量控制方法 野拔子 特征图谱 含量测定 

分 类 号：R932[医药卫生—生药学]