利金颗粒的制备工艺及质量研究

The Preparation Technology and Quality Research of Lijin Granules

目的优选利金颗粒的制备工艺并进行相关质量研究。方法以软材性状、颗粒成型率等为指标,进行混合辅料的筛选;考察颗粒的性状、溶化性以及相关含量测定等,对制剂进行质量研究。结果优选的最佳辅料为浸膏粉∶甘露醇∶乳糖=33.3∶13.42∶53.28,以75%乙醇制软材,所得颗粒质量稳定,黄芪甲苷平均含量0.036%,RSD为2.08%。结论优选出的制备工艺以及质量研究简单合理,工艺稳定,可操作性强,结果满意。

Objective To preferred the preparation technology and quality research of the Lijin granules. Methods Taking soft material traits and particles pass rate as the index, the mixed materials were selected. The formulations quality with studying the particles traits, melting and the determination of the granules were studied. Results The preferred out the best materials was extract powder：mannitol： lactose = 33.3： 13.42： 53.28, and made the soft material with 75% ethanol, which the method of the resulting particles quality and stability, the average content of Astragaloside was 0.036 % and with the RSD was 2.08%. Conclusion The preferred preparation process and the quality standards was simple and reasonable, and the process had stability and operability.