番泻叶颗粒的成型工艺试验

Study on the forming process of senna granules

为了筛选番泻叶颗粒剂的最优成型工艺,通过正交试验,以颗粒的成型性、堆密度、休止角、溶化性和吸湿率为考察指标,筛选出颗粒剂的最佳辅料,辅料配比、乙醇用量及体积分数的工艺参数;结果:番泻叶颗粒采用湿法制粒筛选出的最佳辅料为蔗糖和糊精,蔗糖和糊精的配比为2∶1,乙醇的体积分数为80%,乙醇用量(g)为6.7%,干燥温度50℃,干燥时间5 h,环境湿度需控制在73%以下;表明该颗粒剂所选辅料合理,成型制备工艺可行,符合2015年版《中国兽药典》二部要求。

objective： To study the optimal forming process of senna granules. methods： the orthogonal test was employed,and the five factors of formability,bulk density,repose angle,solubility and hygroscopicity were selected for studying the optimal process parameters（ excipient,ratio of excipient,ethanol volume,volume fraction）. results： the sucrose and dextrin were determined to to be optimal excipient by wet legal system grain. All of the ratio of sucrose and dextrin was 2/1,ethanol volume was about 6. 7%（ ethanol volume fraction was 80%）,the tempertrue was 50 ℃,and the dying time was 5 h. The environmental humidity of production was controlled to be below 73%,to reduce the effect of humidity on the stability. conclusion： the selected excipient and manufacture process were reasonable for making senna granules. And all the test items were detected and conformed to the china veterinary pharmacopoeia（ 2015 editions）.