柔肝宝颗粒剂的成型性工艺

目的:正交试验法优选柔肝宝颗粒剂的成型性工艺。方法:考察常用辅料糊精、乳糖、可溶性淀粉、微晶纤维素及混合辅料,对颗粒成型率、吸湿率、休止角的影响,并采用正交试验法,以辅料用量、乙醇体积分数、乙醇用量为考察因素,优选柔肝宝颗粒最佳成型性工艺。结果:以乳糖和糊精按1∶1混合为成型辅料,浸膏粉(g)与辅料(g)配比为1∶0.8,乙醇体积分数为85%,浸膏粉(g)与乙醇量(mL)比为5∶1,为减少水分对药物质量的影响,环境湿度应控制在67%以下。结论:该工艺可靠、稳定、重复性好,符合《中国药典》2015年版四部"颗粒剂"各项要求,为中试及大生产提供了参考依据。

Forming technology of Rouganbao granules

OBJECTIVE To establish the optimal formulation of Rouganbao granules.METHODS The different accessories had influenced rate, moisture absorption rate, repose angle, like lactose, including soluble starch, lactose, microcrystalline cellulose, and mixed accessories. Processing conditions were optimized by orthogonal test to achieve the best forming process, with investigation factors including accessories amounts, ethanol concentration, and ethanol amounts.RESULTS The forming accessories were lactose and dextrin mixed by 1:1. The ratio of gypsum powder (g) to accessories (g) was 1:0.8. Ethanol concentration was 85%. The ratio of extract powder (g) and ethanol volume was 10:1. To reduce the impact of water on drug quality, the ambient humidity should be controlled below 67%.CONCLUSION The process is reliable, stable and repeatable, meeting the requirements of ‘Chinese Pharmacopoeia’ 2015 four edition on ‘granules’, which provides a reference for the pilot and large production.