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目的建立并提升软肝缩脾丸的质量标准。方法采用显微鉴别法、薄层色谱法对软肝缩脾丸中的黄芪、丹参、赤芍、鳖甲、大黄、五味子、桃仁、三七进行定性鉴别;采用HPLC测定芍药苷、丹酚酸B的含量。色谱柱为Wondasil C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液,梯度洗脱,流速:1.0 mL·min~(-1),检测波长230,286 nm,柱温:30℃,进样量:10μL。结果 4味药材的显微特征明显;5味药材的薄层色谱斑点清晰,分离度良好,阴性无干扰;HPLC显示芍药苷在9.79~195.80μg·mL~(-1)(r=0.999 9)、丹酚酸B在11.45~229.00μg·mL~(-1)(r=0.999 9)内线性关系良好,平均回收率分别为100.6%,101.9%,RSD分别为1.26%,1.05%。结论本方法简便、快捷、结果准确、重复性好,可用于软肝缩脾丸的质量控制。
Objective To establish and improve the quality standard of soft liver shrinking spleen pill. Methods The microscopic identification method and TLC were used to qualitatively identify Astragalus membranaceus, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, turtle shell, rhubarb, Schisandra chinensis, Peach kernel and Panax notoginseng in Ruiganpuxue pill. The contents of paeoniflorin, B content. The mobile phase consisted of acetonitrile-0.1% phosphoric acid solution with gradient elution at a flow rate of 1.0 mL · min -1 with a wavelength of 230.286 nm on a Wondasil C 18 column (250 mm × 4.6 mm, 5 μm) Column temperature: 30 ℃, injection volume: 10μL. Results Four kinds of medicinal herbs showed obvious microscopic features. The TLC spots of the five medicinal herbs were clear, with good resolution and negative interference. The HPLC showed that the paeoniflorin was in the range of 9.79 ~ 195.80 μg · mL -1 (r = 0.999 9) The linear range of salvianolic acid B was 11.45 ~ 229.00 μg · mL -1 (r = 0.999 9). The average recoveries were 100.6% and 101.9%, respectively, with RSDs of 1.26% and 1.05%, respectively. Conclusion This method is simple, rapid, accurate and reproducible. It can be used for the quality control of Ruiganzhuipiwan.