通脉颗粒质量标准

Quality Standard of Tongmai Granules

目的：建立通脉颗粒的质量标准。方法：采用薄层色谱法对方中黄芪、红参、三七、赤芍进行定性鉴别;采用HPLC测定通脉颗粒中三七皂苷R1,人参皂苷Rg1,人参皂苷Re及人参皂苷Rb1的总量。结果：本品TLC定性鉴别薄层色谱斑点清晰,专属性强,重复性好。HPLC测定三七皂苷R1,人参皂苷Rg1,人参皂苷Re及人参皂苷Rb1进样量分别在0.058 8~0.588 0,0.487 9~4.879,0.104 9~1.049,0.308 3~3.083μg呈良好的线性关系,r分别为0.999 6,0.999 6,0.999 7,0.999 6,平均加样回收率为95.34%（RSD 1.8%）,95.42%（RSD 2.0%）,98.99%（RSD 1.8%）,102.13%（RSD 1.8%）。结论：该方法准确灵敏,简便,专属性强、重复性好,适用于通脉颗粒的质量控制。

Objective： To establish quality standards of Tongmai granules. Method： Ginseng Radix et Rhizoma Rubra,Astragali Radix,Notoginseng Radix et Rhizoma and Paeoniae Radix Rubra in Tongmai granules were identified by TLC; the contents of notoginsenoside R1,ginseng saponins Rg1,ginseng saponins Re and ginseng saponins Rb1 were determined by HPLC. Result： TLC spots were clear and specific in good repeatability.Linear ranges of notoginsenoside R1,ginseng saponins Rg1,ginseng saponins Re and ginseng saponins Rb1were0. 058 8-0. 588 8,0. 487 9-4. 879,0. 104 9-1. 049 and 0. 308 3-3. 083 μg, average recoveries were 95. 34%（ RSD 1. 8%）,95. 42%（ RSD 2. 0%）,98. 99%（ RSD 1. 8%） and 102. 13%（ RSD 1. 8%）,respectively.Conclusion： This method is accurate,sensitive,simple and specific in good repeatability,which is suitable for quality control of Tongmai granules.