冷冻干燥法和高速搅拌法制备生脉饮颗粒剂的研究

Study on Preparation of Shengmaiyin of Traditional Chinese Medicine Granules Using Freeze-Drying and High Shear Mixing Technique

为了改善传统的中药制剂、方便服用,同时提高病人的顺应性,以传统的生脉饮制剂为模型药物,将其处方药材浸出液进行冷冻干燥,干燥物与不同的辅料混合,用高速搅拌粒法制成颗粒剂。结果表明,选择微粉硅胶与双歧糖为颗粒剂辅料,与浸膏干燥物的混合比例为1∶3,再加入粘合剂10%HPMC的80%乙醇溶液4.0mL,即可使混合制粒顺利进行,粒度均匀,吸湿量低。因此,可以采用该方法制备中药颗粒剂,防止中药浸膏粉吸潮,提高中药颗粒剂的稳定性。

To improve the traditional preparation of Chinese medicine Shengmaiyin for patient to take medicine conveniently, the liquid extract of Shengmaiyn as a model was dried by freezing-drier to form extract dryness. The extract dryness was formulated with micronization silica gel in different ratios and granulated with high shear mixer granulator. It was feasible that the extract dryness was mixed with excipients including silica gel and micron silica gel in ratio of 3 to 1 with 4.0 mL of 10%HPMC of 80% ethanol solution. The process of granulation was going smoothly, the uniform granules was obtained, the moisture absorption was lower. The freezing-drying and high shear mixing techniques could be used to prepare the granules of the traditional Chinese medicine for lowering the moisture absorption of extract dryness and improving the stability of granules.