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作 者:秦永丽[1] 张宇[1] 于莲[1] 王宇亮[1] 荣芳悦 丛晶男
机构地区:[1]黑龙江省高校生物药制剂重点实验室,佳木斯大学药学院,黑龙江佳木斯154007
出 处:《中国药学杂志》2016年第1期35-39,共5页Chinese Pharmaceutical Journal
基 金:国家自然科学基金资助项目(81274101);佳木斯大学科技创新团队基金资助项目(CXTD-2013-05)
摘 要:目的研究黄芪多糖p H依赖-时滞性结肠靶向微丸的制备工艺。方法采用挤出-滚圆法及流化床包衣法制备结肠靶向剂黄芪多糖微丸,响应面优化法筛选最佳制备工艺。结果丸芯组成:黄芪多糖药粉、微晶纤维素、微粉硅胶、交联羧甲基纤维素钠比例为25∶15∶8∶2,水为润湿剂挤出滚圆成丸,挤出速率为60 r·min^(-1),滚圆速率为1 400 r·min^(-1),滚圆时间为4min。最佳流化床包衣条件是风机频率为29.50 Hz,喷枪压力为0.70 kg·cm^(-2),包衣流速为3.00 m L·min^(-1),包衣增重为15%。微丸在人工胃液中2 h释放度为0%,在人工小肠液中3 h释放度<5%,在人工结肠液2 h释放完全。结论该制备方法适用于黄芪多糖微丸的制备,操作简单,重现性良好,适用于工业生产。OBJECTIVE To study the preparation process of pH-dependent delayed colon targeting pellets of astragalus polysac- eharide. METHODS Colon targeting agents of APS pellets were produced by extrusion-spheronization and fluid bed coating method and the best preparation technology was chosen by response surface optimization method. RESULTS The ratio of pill core : APS pow- der-avicel-tannie acid-carboxymethylcellulose sodium was 25: 15: 8: 2, the wetting agent was water, the rate of extrusion was 60 r ~ min- J , the rate of spheronization was 1 400 r ~ min- 1 , and the time of spheronization was 4 min. The best fluid bed coating condition was as follows the fan frequency was 29. 50 Hz, the pressure of spray gun was 0. 70 kg ~ cm-2, the rate of coating flow was 3 mL ~ min -1, and the colon coating weight was 15%. The release degree of pill for simulated gastric fluid in 2 h was 0% , The release degree of pill for artificial intestinal fluid in 3 h was less than 5%. The release degree of pill for artificial colon fluid in 2 h was release com- pletely. CONCLUSION The preparation method can be qpplied to the preparation of APS pellets, it's simplicity of operator and had good reproducibility, it can be applied to the industrial production.
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