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目的:建立双参根胶囊的质量控制方法。方法:采用TLC法对双参根胶囊中的丹参、人参和葛根进行定性鉴别;采用HPLC法对其中的葛根素、人参皂苷Rg_1进行含量测定。结果:TLC色谱中,供试品溶液在与对照药材相应位置上出现相同颜色的斑点斑点清晰,阴性对照无干扰。HPLC中,葛根素进样量在144.2~1153.6 ng范围内,峰面积与浓度呈良好的线性关系r=0.9999,平均加样回收率为99.94%,RSD为0.13%(n=5);人参皂苷Rg_1进样量在20~160 ng范围内,峰面积与浓度呈良好的线性关系,r=0.999 9,平均加样回收率为99.85%,RSD为0.42%(n=5)。结论:该方法可靠,操作简便,重复性良好河用于双参根胶囊的质量控制。
Objective: To establish the quality control method of Shuangshenge capsule. Methods: Salviae miltiorrhizae, Radix Ginseng and Radix Puerariae were identified qualitatively by TLC method. The contents of puerarin and ginsenoside Rg_1 were determined by HPLC. Results: TLC chromatogram, for the test solution in the corresponding position with the control drug appear the same color spots clear spots, negative control without interference. In HPLC, the injection volume of puerarin was in the range of 144.2-1153.6 ng, the linear relationship between peak area and concentration was r = 0.9999, the average recovery was 99.94% and the RSD was 0.13% (n = 5) The Rg_1 injection volume was in the range of 20-160 ng, and the peak area was linear with the concentration. The average recovery was 99.85% and the RSD was 0.42% (n = 5). Conclusion: The method is reliable, easy to operate and reproducible. The method is used for the quality control of Shuangshenge Capsule.