铁必复颗粒质量标准研究

Quality Standard of Tiebifu Granules

目的建立铁必复颗粒的质量标准。方法采用薄层色谱(TLC)法对制剂中大黄、葛根、川芎和石菖蒲4味药进行定性鉴别;以高效液相色谱(HPLC)法测定葛根中葛根素的含量,色谱柱采用Lichrospher C_(18)柱(250 mm×4.6 mm,5μm),以甲醇-水(25∶75)为流动相,检测波长为250 nm。结果供试品溶液在与对照品溶液或对照药材溶液相应位置上显相同颜色的斑点,阴性对照无干扰;葛根素质量浓度线性范围是23.84~143.02μg/mL(r=1.000 0)。结论该质量标准专属性强,准确度高,重复性好,可作为其质量控制标准。

Objective To establish the quality standard of Tiebifu Granules. Methods The Radix Rheum palmatum, Radix Puerasiae,Rhizoma Ligustici wallichii and Rhizoma Acori tatarinowii in the preparation were qualitatively identified by TLC method. The content of puerarin in Radix Puerasiae was determined by HPLC. The separation was performed on Lichrospher C18 column（ 250 mm × 4. 6 mm,5 μm）with a mobile phase of methanol-water（ 25 ∶ 75） at the detection wavelength of 250 nm. Results The test solution showed the same color spots in the corresponding position of the reference solution or the reference herb solutions,and the TLC spots were clear without interference. The puerarin showed a good linear relationship within the range of 23. 84-143. 02 μg/mL（ r = 1. 0000）. Conclusion The quality standard has strong specificity,high accuracy and good repeatability,which can be used as the quality control standard of Tiebifu Granules.