六锐胶囊的质量标准研究

Study on Quality of Liu Rui Capsules

目的建立六锐胶囊的质量控制方法。方法薄层色谱法鉴别处方中的红花、木香、诃子,气相色谱法鉴别处方中的麝香;高效液相色谱法以Agilent Eclipse XDB-C18(4.6mm×150mm,5μm)为分析柱,乙腈-0.7%磷酸溶液(10∶90)为流动相,检测波长:403nm,测定方中红花的羟基红花黄色素A含量。结果用薄层色谱法鉴别出处方中的红花、木香、诃子,用气相色谱法鉴别出处方中的麝香;羟基红花黄色素A在5.31～106.2μg.mL-1浓度范围内,线性关系良好(r2=0.999 6)。平均回收率为96.4%,RSD为1.3%(n=9)。结论所建立的方法简便易行、准确、重复性好,可用于六锐胶囊的质量控制。

Aim To estabilsh a method for quality control of Liu Rui Capsules. Methods Flos carthami , Radix aucklandiae and Fructus chebulae were identified by TLC and Moschus identified by GC. The hydroxyl safflor yellow A was determined by HPLC. The condition of HPLC involved Agilent Eclipse XDB-C18 column （5μm, 4.6mm ×150mm ）, acetonitrile-0.7% phosphoric acid （ 10：90 ） as the mobile phase. The detective wavelength was set at 403nm. Results Flos carthami, Radix aucklandiae and Fructus chebulae can be identified by TLC;and Moschus can be identified by GC. Good linearity was obtained in the range 5.31- 106.2μg.mL^-1 （ r 2 =0.999 6）. The recovery and RSD % were 96.4% and 1.3% respectively （ n =9）. Conclusion The method is simple, accurate, reproducible and can be used for quality control of Liu Rui Capsules.