中药制剂冠心汤的质量标准研究  

Study on Quality Standard of Guanxin Decoction Prepared by Medical Institutions

作　　者：黄志强[1] 王一男 徐泽 Huang Zhiqiang;Wang Yinan;Xu Ze(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510275;Xuzhou Medical Universitym,Xuzhou 221004)

机构地区：[1]广州中医药大学附属第二医院,广东广州510275 [2]徐州医科大学,江苏徐州221004

出　　处：《广东化工》2023年第14期40-43,共4页Guangdong Chemical Industry

摘　　要：冠心汤是中医院特色中药制剂,可用于冠心病的治疗。为保证用药安全、有效,本实验对冠心汤的质量标准进行了初步研究,建立薄层色谱鉴别冠心汤中的黄芪,以及冠心汤中黄芪甲苷的含量测定方法。采用薄层色谱法对冠心汤中黄芪药材进行鉴别,薄层板为硅胶G薄层板,展开剂为二氯甲烷-甲醇-水(13∶7∶2);采用高效液相色谱法评价冠心汤中黄芪甲苷的含量,色谱柱为InertsilC18柱(250 mm×4.6 mm,3.5μm),流动相为乙腈-水(32∶68),流速1.0mL/min,进样体积20μL,柱温为室温,检测波长203 nm。结果显示薄层色谱分离效果较好,阴性无干扰。高效液相色谱方法学验证,表明方法专属性好。在测定浓度范围内黄芪甲苷峰面积与浓度的线性关系良好(r=0.9992),精密度实验RSD=2.36%,回收率在90.0%~110.0%之间,黄芪甲苷平均含量为0.83 mg/mL。结论:所建立的冠心汤鉴别、含量测定方法准确、精密,可用于冠心汤的质量控制。Guanxin Decoction is a characteristic Chinese medicine preparation in Hospital of Traditional Chinese Medicine,which can be used to treat coronary heart disease.In order to ensure the safety and effectiveness of drug use,the quality standard of Guanxin Decoction was preliminarily studied in this experiment,and the identification of Astragalus in Guanxin Decoction by TLC and the determination method of astragaloside IV in Guanxin Decoction were established.Radix Astragali was identified by TLC.The TLC plate was silica gel G,and the developing agent was dichloromethane-methanol-water(13∶7∶2).The content of astragaloside IV in Guanxin Decoction was evaluated by HPLC.The chromatographic column was Inertsil C18 column(250 mm×4.6 mm,3.5μm),the mobile phase was acetonitrile-water(32∶68),the flow rate was 1.0mL/min,the sample volume was 20μL,the column temperature was room temperature,and the detection wavelength was 203nm.The separation effect of TLC was good,and there was no interference.The verification of HPLC methodology shows that the method is specific.The linear relationship between the peak area of astragaloside IV and the concentration is good(r=0.9992),the precision test RSD is 2.36%,the recovery rate is between 90.0%and 110.0%,and the average content of astragaloside IV is 0.83 mg/mL.Conclusion:The established method for identification and content determination of Guanxin Decoction is accurate and precise,and can be used for quality control of Guanxin Decoction.

关 键 词：冠心汤 黄芪甲苷 质量控制 薄层色谱法 高效液相色谱法 

分 类 号：TQ[化学工程]