三金通淋排石颗粒质量标准的研究  

Quality Standard of Sanjin Tonglin Paishi Granules

作　　者：唐莉华 黄学娣 蒋司晨 李凡 TANG Lihua;HUANG Xuedi;JIANG Sichen;LI Fan(Department of Pharmacy,Jiangxi Hospital of Integrated Traditional and Western Medicine,Jiangxi Province,Nangchang 330003,China)

机构地区：[1]江西省中西医结合医院药剂科,江西南昌330003

出　　处：《光明中医》2024年第4期695-698,共4页GUANGMING JOURNAL OF CHINESE MEDICINE

基　　金：江西省卫生健康委科技计划项目(No.202211480);国家中医药管理局全国中药特色技术传承人才培训项目(No.T20184828005);江西省中医药管理局中青年骨干人才培养。

摘　　要：目的 通过色谱法建立三金通淋排石颗粒质量控制方法。方法 应用薄层色谱法对三金通淋排石颗粒中炒栀子和鸡内金进行定性鉴别;应用高效液相色谱法对三金通淋排石颗粒中栀子苷进行定量测定。结果 薄层色谱法能特征性地鉴别炒栀子和鸡内金,结果清晰,分离度好,阴性无干扰;高效液相色谱法测定栀子苷的含量,并进行方法学研究,精密度、重复性、稳定性均符合相关规定,栀子苷进样量在130.1~1301.1 ng(r=0.9992)范围内呈现良好的线性关系,平均加样回收率为98.75%,RSD为0.61%。结论 此实验方法操作简便易行,专属性强,准确度高,重复性好。为三金通淋排石颗粒质量标准的建立,提供了实验依据,可应用于三金通淋排石颗粒的质量控制。Objective To establish a quality control method for Sanjin Tonglin Paishi granules by chromatography.Methods TLC was used to qualitatively identify Gardeniae Fructusand and Galli Gigerii Endothelium Corneum in Sanjin Tonglin Paishi granules.HPLC was used to quantitative determination Geniposide in Sanjin Tonglin Paishi granules.Results TLC can distinguish Gardeniae Fructusand and Galli Gigerii Endothelium Corneum,with clear results,good resolution and no negative interference.HPLC can determination Geniposide,and conduct methodological research.The precision(RSD:0.58%),repeatability(RSD:0.94%) and stability(RSD:0.73%) were all in line with the relevant regulations.The calibration curve of Geniposide showed good linear relationship in the range of 130.1 to 1301.1 ng(r=0.9992),and the average recovery was 98.75%(RSD:0.61%).Conclusion The method is easy to operate,strong in specificity,accuracy with high and good repeatability.In order to establish the quality standard for Sanjin Tonglin Paishi granules,an experimental basis was provided.It can be applied for the quality control of Sanjin Tonglin Paishi granules.

关 键 词：三金通淋排石颗粒 质量标准 薄层色谱 高效液相色谱 栀子苷 鸡内金 

分 类 号：R284[医药卫生—中药学]