参杞强精颗粒制备工艺优化及质量标准的建立

Study on the preparation process and quality standards of Shenqi Qiangjing granules

采用正交试验法优化参杞强精颗粒水煎煮工艺,并采用单因素试验确定最佳制剂成型工艺。采用薄层色谱法(TLC)对处方中的淫羊藿、五味子药材进行定性鉴别,初步建立了参杞强精颗粒的质量标准。结果表明,最佳提取工艺为药材加10倍量水,煎煮提取3次,每次1.5 h;最佳成型工艺为稠膏与糊精比例1∶1,65%乙醇为润湿剂,0.3%甜菊素为矫味剂,所得颗粒溶化性、成型性好,口感适宜;淫羊藿、五味子定性鉴别的斑点清晰,鉴别方法简单可行、专属性强,可作参杞强精颗粒质量的内控标准。

The orthogonal test was used to optimize the decoction process of Shenqi Qiangjing granules,and the best moulding process was determined by single factor test.The thin layer chromatography(TLC)was performed to identify Epimedium and Schisandra Chi⁃nensis,the quality standards of Shenqi Qiangjing granules was established.The results showed that the optimum extraction process was 10 times amount of water and fried and extracted three times for 1.5 h each;The optimum moulding process was the ratio of thick paste and dextrin of 1∶1,65%ethanol as the wetting agent,and 0.3%stevia as the correction agent,the obtained granulas had good solubility,good forming properties and appropriate taste;The spots of qualitative identification of Epimedium and Schisandra Chinen⁃sis were clear,the identification method was simple and feasible,and could be used as an internal control standard for the quality of Shenqi Qiangjing granules.