摘要
目的确定桑元止渴胶囊剂成型工艺条件。方法以体止角、吸湿性、堆密度、临界相对湿度为考察指标,筛选出其处方中加入辅料的品种、配比及其最佳成型工艺,确定胶囊型号及装药量。结果微晶纤维素为辅料抗湿性能较好,桑元止渴胶囊的最佳成型工艺为:浸膏粉与辅料按8∶2的比例混匀,加入0.5倍95%乙醇制软材;制得颗粒流动性较好,临界相对湿度为68%,堆密度为0.726g.mL-1,选用0号胶囊,每粒装0.5g。结论该成型工艺合理、可行,为大生产提供了科学依据。
Objective To study the production process of Sangyuan Zhike Jiaonang. Methods The best production process was determined by surveying the physical characteristics such as angle of repose,pile-density,critical relative humidity and hygroscopicity. Results Microcrystalline cellulose as excipients had a good anti-wet performance.The extract powder and microcrystalline cellulose were mixed evenly at 8∶2,and 95% alcohol was used as the wetting agent.The granules of end product had a good fluidity,the critical relative humidity was about 68%,bulk density was 0.726 g·mL-1,and 0.5 g was contained in each size 0 capsule. Conclusion The molding technology is reasonable,and can provide reliable basis for mass production.
出处
《中南药学》
CAS
2012年第1期7-9,共3页
Central South Pharmacy
基金
广东省科技计划项目(项目编号:2008A030201031)
关键词
桑元止渴胶囊
成型工艺
临界相对湿度
Sangyuan Zhike Jiaonang
production process
critical relative humidity
作者简介
陈强，男，药师，主要从事中西药制剂研究，Tel：（020）36652004，E—mail：aier2230@126．com
通讯作者：罗新根，男，硕士，副主任药师，主要从事中药新药、质量标准研究，Tel：（020）36653198，Email：lou0666@163．com
