羌药验方制剂大香连丸质量标准研究

Study on quality standard of Qiang medicine empirical formula Daxianglian pill

目的:建立羌药验方大香连丸的质量控制方法。方法:采用薄层色谱法(TLC) 法鉴别方中木香、黄连和大黄;采用高效液相色谱(HPLC)法测定大香连丸中木香烃内酯和去氢木香内酯的含量,色谱柱为Chromplus?C色谱柱(4.6mm×150 mm,5 μm),流动相为甲醇-0.1%甲酸水溶液(70∶30,v/v),流速为1 mL·min^(-1),检测波长为225 nm,柱温为30℃。结果:薄层色谱鉴别方法专属性强,斑点清晰,且阴性无干扰;木香烃内酯、去氢木香内酯分别在2.46~49.15μg·m L^(-1)、4.74~94.70 μg·mL范围内呈良好的线性关系,大香连丸中木香烃内酯、去氢木香内酯平均总含量为7.81 mg·g^(-1)。结论:该方法简便可行、专属性强、重现性好,可用于羌药大香连丸的质量控制。

Objective: To establish a method for the quality control method of Qiang medicine empirical formula Daxianglian pill. Method: TLC method was used to identify Muxiang, Huanglian and Dahuang in Daxianglian pill. The contents of costunolide and dehydrocostus lactone in Daxianglian pill were detected by HPLC on Chromplus?Ccolumn (4.6 mm×150 mm, 5 μm). The mobile phase was methanol-0.1% formic acid-water solution (70:30, V/V) at a flow rate of 1 mL·min^(-1). The detection wavelength was 225 nm, and column temperature was 30 ℃. Result: The TLC identification method was highly specific, with clear spots and negative results without interference. Costunolide and dehydrocostus lactone had a good linearity within the ranges of 2.46-49.15μg·mLand 4.74-94.70 μg·mL, respectively, with the average total content of 7.81 mg·g^(-1). Conclusion: The method is simple and feasible with strong specificity and good reproducibility, and can be used for the quality control of Qiang medicine Daxianglian pill.