复方头痛灵颗粒质量标准的研究

Compound Toutongling granules of quality standards

目的制定复方头痛灵颗粒的质量标准。方法采用薄层色谱法（TLC）进行定性鉴别,高效液相色谱法（HPLC）测定天麻素的含量。色谱条件：Hyperisil ODS（5μm,200 mm×4.6 mm）,流动相为甲醇：0.1%磷酸（12∶88）,流速1 ml/min,检测波长222 nm,柱温：30℃。结果TLC色谱中斑点清晰,易于识别;HPLC法精密度、重现性良好。天麻素在0.08--0.44μg范围内具有良好的线性关系,平均回收率为95%（RSD=2.00%）。结论本法可有效控制复方头痛灵颗粒的质量。

Objective To establish the method for quality standard of compound Toutongling granules. Methods TLC and HPLC method were used to identify the Chinese herbal medicines. The determination was carried on HPLC, using hyperisil ODS column （5μm, 200 mm × 4. 6 mm） , ethanol-0. 1% phosphoric acid solution（ 12： 88）as mobile phase, detected at the wavelength of 222 nm and the column temperature of 30℃. Resuits The TLC sports developed were fairly and simply identical. HPLC was accurate and reproducible. A good linearity was obtained in the range of 0. 08--0. 44 μg,and the average recovery was 95% with RSD =2.00%. Conclusion The methods can be used to control the quality of compound TouTongLling Granules effectively.