摘要
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 Ruangan Suopi pill. METHODS Microscopic identification and TLC were conducted for the qualitative identification of Astragali Radix, Salviae Miltiorrhizae Radix et Rhizoma, Paeoniae Radix Rubra, Trionycis Carapax, Rhei Radix et Rhizoma, Schisandrae Chinensis Fructus, Persicae Semen, Notoginseng Radix et Rhizoma in Ruangan Suopi pill; HPLC was performed to determine the contents of paeoniflorin and salvianolic acid B. It was performed on column of Wondasil C18（250 mm×4.6 mm, 5 μm）with mobile phase of acetonitrile -0.1% phosphonic acid in linear gradient elution mode at the flow rate of 1.0 mL·min-1, the UV detection wavelength of 230 nm and 286 nm, the column temperature of 30 ℃ and the volume of 10 μL. RESULTS The microscopic identification showed microscopic characteristics of four traditional Chinese medicines. TLC spots of the five traditional Chinese medicines were clear and well-separated without negative interference. The HPLC experiment results showed the good linearities in the range of 9.79-195.80 μg·mL^-1 （r=0.999 9） for paeonifiorin, 11.45-229.00 μg·mL^-1 （r=0.999 9） for salvianolic acid B, respectively. The average recovery rates of two compounds were 100.6%, 101.9%, and RSD were 1.26%, 1.05%. CONCLUSION The method is rapid, convenient, accurate, repeatable, and suitable for quality control of Ruangan Suopi pill.
出处
《中国现代应用药学》
CAS
CSCD
2017年第4期542-548,共7页
Chinese Journal of Modern Applied Pharmacy
基金
军队医疗机构制剂标准提高科研专项课题重点项目(14ZJZ02)
