复方天麻颗粒质量标准的研究

Study on quality standard of compound Tianma granules

目的:建立复方天麻颗粒的质量标准。方法:采用薄层色谱法对方中五味子、麦冬进行鉴别。用高效液相色谱法对天麻中有效成分天麻素进行含量测定。色谱柱为 Kromasil-C_(18)柱(4.6 mm×250 mm,5 μm),柱温25℃;流动相为乙腈-0.05%磷酸溶液(2.5:97.5),流速1.0 mL·min^(-1);检测波长为220 nm。结果:薄层鉴别,色谱特征斑点明显;高效液相色谱法测定,天麻素在0.21～0.83 μg范围内线性关系良好(r=0.9999),平均回收率为98.2%(RSD=1.6%,n=6)。结论:本方法可有效地控制复方天麻颗粒的质量。

Objective：To establish a qualitive standard for compound Tianma granules. Method：Crude Fructus Schisandrae Chinensis and Radix Ophiopogonis in compound Tianma granules were identified by TLC. The content of gastrodin in Rhizoma Gastrodiae of compound Tianma granules was determined by HPLC, using a Kromasil - Cls column （4. 6 mm × 250 mm,5 μm）, the column temperature was fixed on 25℃, acetonitrile -0. 05 % phosphoric acid solution（2. 5：97.5 ） as mobile phase, flow -rate was 1.0 mL 2min^-1 ;the detecting wavelength was set at 220 nm. Results：In TLC ,the spots developed were quite clear;In HPLC ,the linear range of gastrodin was 0. 21 -0. 83μg （ r = 0. 9999 ）, the average recovery of gastrodin was 98.2% with RSD of 1.6% （ n = 6）. Conclusion： The method can be used for the quality control of compound Tianma granules.