复方阿胶颗粒剂的制备工艺与初步稳定性研究  

Preparation and preliminary stability for compound colla corii asini granules

作　　者：易军[1] 蔡育彬 周基清 

机构地区：[1]广东药学院药科学院,广东广州510006 [2]广东药学院 [3]广州托吾泰生物科技有限公司,广东广州510620

出　　处：《广东药学院学报》2013年第6期584-587,共4页Academic Journal of Guangdong College of Pharmacy

基　　金：广东省科技计划项目(2011B031700060)

摘　　要：目的制备复方阿胶颗粒剂,并初步确定其贮存条件。方法以颗粒的休止角、成型性、溶化性、堆密度为指标,通过正交试验筛选颗粒剂的工艺,并通过影响因素试验确定样品的稳定性及贮存条件。结果工艺筛选结果为:以体积分数90%乙醇制粒,过14目筛,以质量分数5%MCC(PH-200)为助流剂;在优选的工艺条件下,颗粒的休止角大于30°,成型性约为98%,溶化率大于93%,堆密度小于0.3 g·mL-1;影响因素试验结果表明,本品对高温和强光稳定,但对环境湿度较为敏感。结论筛选得到的复方阿胶颗粒剂制备方法简便可行,建议密闭、置干燥阴凉处保存。Objective To optimize the formulation of compound colla corii asini granules. Methods According to the indexes of the angle of repose, moldability, dissolution and bulk density, the orthogonal design was used to optimize the formulation. Impact factors test was used to evaluate the stability and determine the storage condition. Results The optimum was as follows： 90% ethylalcohol and 14 screen mesh for granulating, and 5% MCC （PH-200） for lubricating. The angle of repose was larger than 30~, moldability was about 98% , greater than 93% was dissolved, bulk density was less than 0.3 g ~ mL-1. The formulation was stable in the condition of high temperature or strong light, but it was sensitive to environmental humidity. Conclusion The formulation was repeatable and reliable. The compound colla corii asini granules should be kept in dry storage condition with tight packing.

关 键 词：复方阿胶颗粒剂 正交试验 影响因素试验 

分 类 号：TQ461[化学工程—制药化工]