益尔肾片质量标准的研究  

Study on Quality Standard of Yiershen Tablets

作　　者：刘真[1] 陈帅[2] 陈虹林[1] LIU Zhen;CHEN Shuai;CHEN Honglin(Sichuan Second Hospital of Traditional Chinese Medicine,Chengdu 610031,China;Sichuan Academy of Chinese Medical Sciences,Chengdu 610041,China)

机构地区：[1]四川省第二中医医院,四川成都610031 [2]四川省中医药科学院,四川成都610041

出　　处：《中国民族民间医药》2024年第23期67-70,共4页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：四川省科技厅公益性科研院所基本科研项目(编号:2021-4-642);四川省中央引导地方科技发展专项项目(立项编号:2022ZYD0106)。

摘　　要：目的:建立益尔肾片质量标准。方法:采用薄层色谱法(TLC)对益尔肾片中的水蛭进行定性鉴别,采用高效液相色谱法(HPLC)法测定益尔肾片中的毛蕊异黄酮苷的含量。结果:TLC方法显色清晰,分离效果良好,阴性对照无干扰;含量测定结果显示,毛蕊异黄酮苷0.028~1.120μg内峰面积与进样量呈良好的线性关系,线性方程为Y=3340.2X-12.963(r=0.9999),平均回收率为100.04%,相对标准偏差(RSD)为2.17%(n=6)。结论:所建立的质量标准简单准确、灵敏高效,能有效地控制益尔肾片的质量。Objective To establish a quality standard for Yiershen Tablets.Methods TLC was adopted for qualitative identification and HPLC was used for determination of calycosin-7-glucoside in Yiershen Tablets.Results The TLC method has clear color rendering,good separation effect and no interference in the negative control.The content determination results show that calycosin-7-glucoside is 0.028-1.120μg.The peak area within exhibits good linearity with the injection volume.The average recovery rate is 100.04%with an RSD of 2.17%(n=6).Conclusion The established quality standards are simple,accurate,sensitive and efficient,which can effectively control the quality of Yiershen tablets.

关 键 词：益尔肾片 薄层色谱 高效液相色谱 水蛭 毛蕊异黄酮苷 

分 类 号：R284[医药卫生—中药学]