芪参胶囊的质量标准研究

Study on Quality Standard of Qishen Capsules

目的建立芪参胶囊的质量标准。方法采用薄层色谱法对芪参胶囊中三七、人参、制何首乌和甘草进行定性鉴别;用高效液相色谱法-蒸发光散射检测器(HPLC-ELSD法)测定三七中三七皂苷R1和黄芪中黄芪甲苷的含量。结果应用所建立的方法对样品进行定性与定量分析,结果在TLC色谱中均可检出与对照品或对照药材相同的斑点,且阴性无干扰。三七皂苷R1进样量在1.2732～7.6392μg范围内,其对数值与峰面积对数值呈良好的线性关系,平均加样回收率为97.66%,RSD为1.66%;黄芪甲苷进样量在0.6144～4.9152μg范围内,其对数值与峰面积对数值呈良好的线性关系,平均加样回收率为100.51%,RSD为1.57%。结论该方法操作简便,重现性好,结果准确可靠,可用于芪参胶囊的质量控制。

Objective To establish the quality standard of Qishen Capsules. Methods The thin layer chromatography was used to identify Radix notoginseng, ginseng, Radix polygonum multiflorum preparata and Radix glycyrrhizae in Qishen Capsules, and the high performance liquid chromatography- evaporative light scattering detector was used to determine the content of notoginsenoside R1 in Radix notoginseng and astragaloside in Astragali radix. Results Samples were analyzed qualitatively and quantitatively by the developed methods. The characteristic spots which were the same as those of reference substances/reference crude materials were obvious in the chromatogram by TLC, and the test showed negative of interference. There was a good linear relationship between the logarithmic of the absorption area and the logarithmic of the concentration in the range of 1. 2732-7. 6392μg for notoginsenoside R1 and 0. 614±4. 9152μg for astragaloside. Their average recoveries of standard addition were 97.66% and 100.51%, RSDs were 1.66% and 1.57% （n = 6）, respectively. Conclusion These methods are simple, repeatable and accurate, and can be used for the quality control of Qishen Capsules.