金槐痔瘘合剂的质量标准提升及应用

目的完善金槐痔瘘合剂的质量控制方法与标准。方法建立鉴别金槐痔瘘合剂中地榆、槐花药材的薄层色谱(TLC)法并进行方法学考察;建立测定其指标性成分芦丁的高效液相色谱(HPLC)法。色谱柱为Diamonsil C18柱(150 mm×4. 6 mm,5μm),流动相为甲醇-0. 4%磷酸水(45∶55),流速为1 m L/min,柱温为35℃,检测波长为257 nm。结果 TLC法专属性强,并能有效鉴别地榆和槐花药材。HPLC方法学考察结果表明,芦丁进样量在0. 010 3~0. 328 mg范围内与峰面积值线性关系良好,回归方程为Y=-1 365. 7 X+8 295. 7,r=0. 999 1(n=6);平均回收率为100. 27%,RSD为1. 24%(n=6)。结论建立的质量控制方法专属性强、稳定性好,完善并提升了金槐痔瘘合剂的质量标准。

Quality Standard Improvement and Application of Jinhuai Zhilou Mixture

Objective To improve the quality control and standard of Jinhuai Zhilou Mixture. Methods A thin-layer chromatography( TLC) method was established to identify the Sanguisorba Officinalis and Sophora Japonica in Jinhuai Zhilou Mixture,and a methodological investigation was performed. A high performance liquid chromatography( HPLC) method was developed to determine its index component,rutin. The column was Diamonsil C18( 150 mm × 4. 6 mm,5 μm),and the mobile phase was methanol-0. 4% phosphoric acid( 45 ∶ 55) with a flow rate of 1 m L/min,a column temperature of 35 ℃,and a detection wavelength of 257 nm. Results The TLC method was highly specific and could effectively identify the materials of Sanguisorba Officinalis and Sophora Japonica. The HPLC methodological results showed that it was in good linear relationship in the range of 0. 010 3-0. 328 mg with the regression equation of Y =-1 365. 7 X + 8 295. 7,r = 0. 999 1( n = 6). The average recovery was 100. 27%,RSD was 1. 24%( n = 6). Conclusion The established quality control method is specific and stable,and it has supplemented and improved the quality standard of Jinhuai Zhilou Mixture.