可溶性大豆多糖作为淫羊藿颗粒成型辅料的研究

Study on soluble soybean polysaccharides as excipient for Epimedium Granules

目的评价可溶性大豆多糖作为淫羊藿颗粒辅料的适用性,并对制剂成型工艺进行优化。方法以可溶性大豆多糖作为单一辅料,采用湿法制粒制备淫羊藿颗粒,通过正交设计试验,对制剂成型工艺进行优化,并与糊精所制备的颗粒比较,考察其溶化性和吸湿性。结果正交试验筛选出的优化工艺为浸膏比重1.33、浸膏温度60℃、浸膏辅料质量比为1∶3.5,此时所制备的淫羊藿颗粒具有较高的成型率和流动性,临界相对湿度为73%,与糊精制备的颗粒相比,其表现出更好的溶化性。结论以可溶性大豆多糖作为辅料制备的淫羊藿颗粒具有良好的适用性,提示可溶性大豆多糖有望成为具有一定应用前景的颗粒辅料。

Objective. To evaluate the applicability of soluble soybean polysaccharide （SSPS） as excipient for Epimedium Granules （EG） and to optimize the molding preparation technology. Methods SSPS was added as excipient for the preparation of EG and the molding preparation technology was optimized by orthogonal design. SSPS was compared with dextrin as excipient for EG by investigating their melting and hygroscopicity. Results When the specific gravity of extract was 1.33, the temperature of extract was 60℃, the proportion of extract and SSPS was 1 ： 3.5, the EG prepared by this way had higher granulation and dissolubility, and the critical relative humidity was 73%. Compared with the granules prepared by dextrin, they showed better dissolubility. Conclusion The EG prepared by SSPS shows good applicability, which promises that SSPS may be a new excipient for granules.