乙肝解毒胶囊的定性定量方法研究  

Investigation on quantitative and qualitative methods for Yigan Jiedu Capsules

作　　者：刘洪超 王欢 林林 于凤蕊 林永强 LIU Hongchao;WANG Huan;LIN Lin;YU Fengrui;LIN Yongqiang(Shandong Institute for Food and Drug Control,Jinan 250101,China;Shandong Hongrun Health Technology Co.,Ltd.)

机构地区：[1]山东省食品药品检验研究院,济南250101 [2]山东泓润健康科技有限公司,济南250101

出　　处：《中国药品标准》2020年第3期206-212,共7页Drug Standards of China

基　　金：山东省自然科学基金项目(ZR2013HM074)。

摘　　要：目的:修订和完善乙肝解毒胶囊的质量标准。方法:采用TLC法对黄柏、黄芩、大黄、胡黄连、拳参、土茯苓进行鉴别;采用HPLC法测定土茯苓中落新妇苷的含量,色谱柱为Kromasil 100-5 C 18(250 mm×4.6 mm,5μm),流动相为甲醇-乙腈-0.1%冰醋酸(8∶11∶81),流速为1.0 mL·min^-1,检测波长为290 nm。结果:TLC斑点清晰,阴性对照无干扰;HPLC含量测定落新妇苷在47.06~941.2ng范围内线性关系良好(r=1.0000),平均回收率为99.01%(RSD为2.0%,n=6),26批次样品测定结果在0~12.032 mg·g^-1之间。结论:本文经方法学验证,可对该制剂进行有效质量控制。Objective:To revise and improve the specification of Yigan Jiedu Capsules.Methods:Phellodendri chinensis Cortex,Scutellariae Radix,Rhei Radix et Rhizoma,Picrorhizae Rhizoma,Bistortae Rhizoma&Smilacis glabrae Rhizoma were identified by TLC.The content of Astilbin in Smilacis glabrae Rhizoma was determined by HPLC.A Kromasil 100-5 C 18 column(250 mm×4.6 mm,5μm)was adopted,the mobile phase consisted of methanol-acetonitrile-0.1%glacial acetic acid solution(8∶11∶81),the flow rate was 1.0 mL·min^-1,and the detection wavelength was 290 nm.Results:TLC spots were clear and the negative sample control showed no interference.The linear range of Astilbin fell into 47.06-941.2 ng(r=1.0000),and the average recovery was 99.01%with RSD 2.0%(n=6).The content results of 26 batches of samples were in the range of 0-12.032 mg·g^-1.Conclusion:The established method are validated and can be used for quality control of Yigan Jiedu Capsules.

关 键 词：乙肝解毒胶囊 薄层色谱法 高效液相色谱法 落新妇苷 

分 类 号：R921.2[医药卫生—药学]