藏药异叶青兰的质量标准研究  

Study on the quality standard of Tibetan medicine Yiyeqinglan

作　　者：赵琳 王嫄 郑东风 纪兰菊 ZHAO Lin;WANG Yuan;ZHENG Dong-feng;JI Lan-ju(Henan Bifu Pharmaceutical Co.,Ltd.,Kaifeng 475500,Henan)

机构地区：[1]河南比福制药股份有限公司研发中心,河南开封475500

出　　处：《中药与临床》2021年第1期6-9,共4页Pharmacy and Clinics of Chinese Materia Medica

摘　　要：目的:对藏药异叶青兰的质量标准进行研究,着重建立异叶青兰中木犀草苷的含量测定方法和TLC鉴别方法。方法:采用TLC法定性鉴别异叶青兰;采用HPLC法建立异叶青兰中木犀草苷的含量测定方法。(1)HPLC色谱条件:色谱柱:C18硅胶柱(大连依利特Hypersil 250×4.6 mm,5μm);流动相为甲醇-0.3%磷酸溶液(32:68);流速:1.0ml·min^(-1);检测波长为350nm;理论塔板数按木犀草苷峰计算应不低于3000。(2)TLC条件:硅胶G薄层板,以乙酸乙酯-甲醇-水-甲酸(25:4:1:0.5)为展开剂,置紫外光灯(365 nm)下检视。结果:HPLC法测定木犀草苷在0.163664-0.81832 mg范围内线性关系良好,平均加样回收率为98.56%,RSD为0.78%;TLC鉴别结果满意。结论:该方法操作简便快速、结果可靠、重复性好,可完善现行《中华人民共和国卫生部药品标准(藏药)(第一册)》项下异叶青兰标准,有效控制异叶青兰的质量。Objective:To study the quality standard of Tibetan medicine Yiyeqinglan,and focus on the establishment of determination method and TLC identification method of luteoloside in Yiyeqinglan.Method:TLC method was used for qualitative identification and HPLC analysis was applied for quantitative determination of Yiyeqinglan with luteoloside as the reference substance.(1)HPLC chromatographic conditions were as following.The column was C18 silica gel column(Dalian Yilite Hypersil250×4.6 mm,5μm).The mobile phase was the mixture of methanol-0.3% phosphoric acid solution(32:68) with a flow rate of1.0 ml·min^(-1).The UV detection wavelength was 350 nm.The number of theoretical plates should not be less than 3000 based on the luteoloside peak.(2)TCL conditions were as following.The silicone thin-layer plate was expanded with ethyl acetatemethanol-water-formic acid(25:4:1:0.5) as the developing agent,and inspected under UV light(365 nm).Result:A good linear relationship was found between the peak areas and injected amounts of luteoloside in the range of 0.163664~0.81832 mg.The average recovery was 98.56%(RSD=0.78%).The TCL identification result was satisfactory.Conclusion:The established method is simple,reproducible and reliable,which can improve the current record in Medicine Standards of the Ministry of Health of the People’s Republic of China(Tibetan Medicine)(Volume 1) and effectively control the quality of Yiyeqinglan.

关 键 词：异叶青兰 木犀草苷 质量标准 

分 类 号：R282[医药卫生—中药学]