益肝片的质量标准研究  

Study on the quality standard of Yigan tablet

作　　者：刘雪萍[1] 邓书武 蒋伟哲[3] LIU Xueping;DENG Shuwu;JIANG Weizhe(Department of Basic Medicine,Guangxi Health Science College,Nanning 530023,China;Department of Pharmacy,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China;College of Pharmacy,Guangxi Medical University,Nanning 530021,China)

机构地区：[1]广西卫生职业技术学院医学基础部,南宁530023 [2]广西医科大学第一附属医院药学部,南宁530021 [3]广西医科大学药学院,南宁530021

出　　处：《广西医科大学学报》2024年第1期124-130,共7页Journal of Guangxi Medical University

基　　金：广西壮族自治区中医药管理局自筹经费科研课题(No.GXZYA20220222,No.GXZYA20230247)。

摘　　要：目的:提升益肝片的质量标准。方法:采用薄层色谱法(TLC)鉴别益肝片中的板蓝根、虎杖;采用高效液相色谱法(HPLC)对益肝片中的(R,S)-告依春和大黄素进行含量测定。结果:通过TLC鉴别板蓝根、虎杖,相应斑点清晰、分离度好,阴性无干扰。(R,S)-告依春在进样量0.03~0.15μg范围内与峰面积线性关系良好(r=0.9998),平均加样回收率为97.05%,大黄素在进样量0.0495~0.297μg范围内与峰面积线性关系良好(r=1.0000),平均加样回收率为99.24%。结论:本质量标准能有效鉴别益肝片中的板蓝根、虎杖,也能有效测定(R,S)-告依春和大黄素的含量,且该法简便、可靠、重复性好,可用于益肝片的质量控制。Objective:To improve the quality standard of Yigan tablet.Methods:Isatidis Radix and Polygonum cuspidatum in Yigan tablet were identified with thin layer chromatography(TLC).The content of(R,S)-Goitrin and Emodin in Yigan tablet was determined by high performance liquid chromatography(HPLC).Results:The spots of Isatidis Radix and Polygonum cuspidatum were clear,well separated and negative without interference when identified.The peak area of(R,S)-Goitrin ranged from 0.03μg to 0.15μg had perfect linear relationship(r=0.9998)with the injection volume,and the average recovery rate was 97.05%;the peak area of Emodin ranged from 0.0495μg to 0.297μg had perfect linear relationship(r=1.0000)with the injection volume,and the average recovery rate was 99.24%.Conclusion:The quality standard can not only effectively identify Isatidis Radix and Polygonum cuspidatum but also can effectively determine the content of(R,S)-Goitrin and Emodin.The method is simple,reliable and repeatable,and can be used for the quality control of Yigan tablet.

关 键 词：益肝片 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R286[医药卫生—中药学]