益母草颗粒工艺改进及质量标准提高的研究

摘要

Objective To establish preparation process and quality standard for Motherwort Granules and improve the quality control. Methods The boiling pelletization techniques was used to prepare the nanoparticles. Motherwort was identified by TLC, Motherwoil Granules was determined by UV-visible spectrophotometry. Results The results showed that, ii improved the preparation process of Motherwort Grannies, the spot of TLC was verv clear, regression equation for Slachv -drine Hydrochloride was Y - 0.605 bX 0.003 1, r - 0.999 4, Stachydrine Hydrochloride detected was stable during 0-8.153 6 mg, the average recover}' of sample was 98.5% (n - 9), RSD - 1.03%, average concentration of samples was 21.5 mg/bag, limit for the content of each bag contained Stachydrine Hydrochloride not less than 18.0 mg. Conclusion The method is accurate and can be used for the quality control of Motherwort Granules.%目的 制订益母草颗粒制剂工艺和质量标准,提高质量的可控性.方法 采用沸腾制粒技术制备颗粒,TLC 鉴别益母草,紫外-可见分光光度法测定含量.结果 改进了颗粒的制剂工艺,薄层色谱法鉴别明显,盐酸水苏碱线性回归方程为:Y = 0.605 6X - 0.003 1,r = 0.999 4,线性范围为0～8.153 6 mg,样品的平均回收率为98.5%(n = 9),RSD = 1.03%,平均含量为21.5 mg/袋,含量限度为每袋中含有盐酸水苏碱不得低于18.0 mg.结论 所建立的方法可准确地进行定性、定量检测,重复性好,可作为益母草颗粒的质量控制.