个厂家药用级二氧化硅的粉体学性质研究Δ.pdf

·制剂与工艺· 6个厂家药用级二氧化硅的粉体学性质研究Δ ＊ # 郝月莆 ，韩 丽 ，秦春凤，张 芳，张定堃，张 超（成都中医药大学中药资源系统研究与开发利用省部共建国 家重点实验室培育基地，成都 611137） 中图分类号 R283.6 文献标志码 A 文章编号 1001-0408（2013）45-4266-04 DOI 10.6039/j.issn. 1001-0408.2013.45.16 摘 要 目的：为二氧化硅在药物制剂中的应用提供参考。方法：收集6个厂家的药用级二氧化硅，对其粒子形态、粒径分布、休 止角、松密度、振实密度、压缩度、含水量、吸湿率、吸水速率及300s 内的最大吸水量等粉体学性质进行测定和分析比较。结果：6 个厂家的样品均呈表面较光滑的圆球状，F 厂家样品的颗粒最为明显；粒径大小为1～100μm ；F 厂家样品的休止角、松密度、振实 密度和压缩度较小，而E 厂家的休止角、松密度、振实密度和压缩度较大，6个厂家样品差异不大；含水量为2.766％～4.738％，6个 厂家样品差异不大；吸湿率为2％～9％，F 厂家样品的吸湿率较低；60s 内吸水速率较快，最大吸水量为1.800～4.000ml ，其中F 厂 家样品的吸水速率及最大吸水量明显大于其他厂家。结论：药用级二氧化硅作为助流剂、助悬剂、抗黏剂、崩解剂等与其流动性、 分散性、吸水性、吸附性等性质有关。 关键词 药用辅料；二氧化硅；粉体学性质；崩解剂；抗黏剂 Study of the Powder Properties of Pharmaceutical-grade Silicon Dioxide HAO Yue-pu ，HAN Li ，QIN Chun-feng ，ZHANG Fang ，ZHANG Ding-kun ，ZHANG Chao （Key Laboratory of System Research and Development of TCM Resource ，Chengdu University of TCM ，Chengdu 611137，China ） ABSTRACT OBJECTIVE ：To provide reference for the application of silicon dioxide in pharmaceutical preparation. METHODS ： Pharmaceutical-grade silicon dioxide collected from 6 manufacturers were measured and analyzed in respects of particle morpholo- gy ，particle size distribution ，angle of repose ，bulk density ，tap density ，compressed limit ，moisture content ，hygroscopic rate ， water absorption rate and maximal water absorbing capacity within 300 s. RESULTS ：The samples from these 6manufacturers were spherical in shape and smooth in appearance ，especially the sample from manufacturer F. The diameter of particles ranged from 1to 100μm ；the angle of repose ，bulk density ，tap density and compressed limit of samples from manufacturer F were lower relative- ly ，while those of samples from manufacturer E were higher relatively ；there was no significant difference in sample from 6manu- facturers. The moisture content ranged 2.766％-4.738％；there was no significant difference among 6ma