复方熊胆茵陈颗粒的制备工艺研究

Study on the preparation technology of Fufang-xiongdan-yinchen granule

目的:制备复方熊胆茵陈颗粒,优选复方熊胆茵陈颗粒剂成型工艺。方法:以颗粒的成型率、休止角、堆密度、溶化性为指标筛选合适的辅料,以口感、成形性为指标筛选最佳矫味剂,并以水分控制确定干燥时间,以绿原酸有无被破坏来确定干燥温度。并了解颗粒的吸湿性及相对临界湿度,控制颗粒的贮藏条件,确保颗粒的质量。结果:复方熊胆茵陈颗粒的最佳配方为复方熊胆茵陈浸膏,加入与熊胆粉混匀的辅料(蔗糖:糊精)以1:1.5:1.5混合,制软材,12目过筛,干燥温度为65℃,10目整粒。结论:筛选得到的复方熊胆茵陈颗粒剂制备方法简便可行,成型工艺稳定可控,建议密闭、置干燥阴凉处保存。

Objective： To prepare Fufang-xiongdan-yinchen granule and optimize the technology. Method： The excipients were optimized with the indexes of moldability, angle of repose, bulk density and dissolution. The best corrigent was chosen with taste and moldability. The drying time was determined with moisture, and the drying temperature was determined with chlorogenic acid content. And the hygroscopicity of granule and critical relative humidity and the storage conditions were considered to ensure granules quality. Result： The optimum formula of Fufang-xiongdan-yinchen granule was optimized. Fufang-xiongdan-yinchen extractum was prepared. Bear gall powder was mixecd with cane sugar and dextrin in the ration of 1：1.5：1.5. After being sieved with 12 screen mesh, the soft material was dryed at 65 ~C and then granulated with 10 screen mesh. Conclusion： The preparation method of Fufang-xiongdan-yinchen granule is convenience. The forming processes is stable and controllable. The granule should be sealed in cool and dry place for preservation.