仙牛颗粒剂制备工艺和质量标准研究

Study on Preparing Technique and Quality Standards of Xianniu Granules

目的研究仙牛颗粒剂的制剂工艺及其质量控制标准。方法采用正交试验法,以总黄酮为指标寻找仙鹤草最佳的提取工艺;采用盐酸-镁粉反应法和薄层色谱法对仙牛颗粒剂中的黄酮进行定性鉴别;采用紫外分光光度法测定仙鹤草中总黄酮含量。结果最佳提取工艺为,加8倍量水,煎煮3次,每次1h;仙鹤草中总黄酮含量测定的回归方程Y=0.0127X+0.0119,r=0.9999,线性范围为20～100μg/mL;定性定量方法简便、准确、专属性强、重现性好。结论制备工艺合理,质量控制方法准确。

Objective To study the preparing technique of Xianniu Granules and its quality standards. Methods The best method of extraction technique of flavonoids in Herba Agrimoniae was optimized by orthogonal text. Further Xianniu Granules were completed with wet- ganulating. Flavonoids in Xianniu Granules were identified by TLC and hydrochloric acid- magnesium reaction, and analyzed by UV at the wavelength of 510 nm. Results The best method of extraction technique was as follows： adding 8 times of water amount, three times of repeated extraction, each for 1 h. The linear range of flavonoids in Herba Agrimoniae was 20 - 100 μg/mL, r =0. 999 9. Conclusion The preparing technique of this preparation is reasonable. And its method of quality control is accurate. The method can be used in the quality control of this preparation.