蓉归通便胶囊成型辅料的筛选与工艺研究

Screening of Formative Excipients for Ronggui Tongbian Capsule and Technique Study

目的:优选蓉归通便胶囊的最佳成型辅料与工艺。方法:采用在温度为25℃、相对湿度75%的条件下,将微晶纤维素、乳糖、微粉硅胶、麦芽糊精、可溶性淀粉与浸膏粉按不同比例混合并进一步制成颗粒,对药粉的吸湿百分率、性状及颗粒的流动性、临界相对湿度进行评价,筛选出最佳辅料及配比,确定最佳成型工艺。结果:蓉归通便胶囊的最佳辅料为微晶纤维素和微粉硅胶,而浸膏粉与辅料的最佳配比为13:7(其中微晶纤维素与微粉硅胶之比为3:4),以95%的乙醇作为粘合剂,14目筛制粒。结论:该研究结果为确定大生产工艺参数提供参考依据。

Objective：To optimize the best formative excipients for Ronggui Tongbian capsule and technology.Methods：With the temperature in 25℃,relative humidity of 75% under the conditions of the microcrystalline cellulose,lactose,silica gel powder,malt dextrin,soluble starch and extract powder by mixing in different proportions and further made of particles of the powder＇s moisture percentage,character and mobility of particles,the critical relative humidity to evaluate the bast accessories and the ratio of screened to determine the optimum molding process.Results：The best accessories for the Ronggui Tongbian capsule microcrystalline cellulose and silica gel powder,while the extract powder and accessories the best ratio of 13：7（including microcrystsiline cellulose and silica gel powder ratio of 3：4）,with 95% ethanol as a binder,14-mesh sieve granulation.Conlcusions：The results of the study to determine the large-scale production process parameters to provide reference.