冠心平颗粒质量标准的研究

Study on Quality Control Standard of Guanxinping Granules

目的建立冠心平颗粒质量标准。方法用TLC法对处方中酒黄精、当归、三七、瓜蒌皮、甘松进行定性鉴别;用HPLC法对制剂中三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1进行含量测定。色谱条件为hedera C18色谱柱;流动相：乙腈-0.1%磷酸溶液进行梯度洗脱;柱温：20℃;流速：1.0mL.min-1;检测波长：203nm。结果在薄层色谱中能检出酒黄精、当归、三七、瓜蒌皮、甘松。三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1分别在0.06211~2.426μg、0.2085~8.144μg、0.2066~8.072μg范围内呈良好的线性关系,r=1.000,平均回收率分别为95.20%、98.51%、97.07%,RSD分别为2.06%、2.07%、2.13%（n=6）。结论本方法简便、准确、重复性好,可用于冠心平颗粒的质量控制。

Objective To establish the quality control standard for Guanxinping Granules.Methods Rhizoma Polygonati Praeparata,Radix Angelicae Sinensis,Radix Et Rhizoma Notoginseng,Pericarpium Trichosanthis and Radix Et Rhizoma Nardostachyos in the preparation were identified by TLC.The content of ginsenoside R1,ginsenoside Rg1 and ginsenoside Rb1 in the preparation were determined by HPLC.Chromatography parameters： the chromatographic column was used,to do gradient elution with acetonitrile-phosphoric acid（at the concentration of 0.1%） as the mobile phase,the column temperature was at 20℃,the flow rate was 1.0mL·min-1 and the detection wavelength was at 203nm.Results Rhizoma Polygonati Praeparata,Radix Angelicae Sinensis,Radix Et Rhizoma Notoginseng,Pericarpium Trichosanthis and Radix Et Rhizoma Nardostachyos have been detected by TLC.The calibration curve was linear in the range of 0.06211~2.426μg for ginsenoside R1,of 0.2085~8.144μg for ginsenoside Rg1 and of 0.2066~8.072μg for ginsenoside Rb1（r=1.000）.The mean reeoveries were 95.20%,98.51%,97.07% respectively,and the RSD was 2.06%,2.07%,2.13%（n=6）respectively.Conclusion This method is simple,reliable and accurate,and it may be used to control the quality of Guanxinping Granules.