Box-Behnken响应面优化莱菔子总碱渗透泵片的制备工艺  

Optimization of Preparation Process of Raphani Semen Total Alkaloids Osmotic Pump Tablets by Box-Behnken Response Surface

作　　者：安欣欣 周洪雷[1] AN Xinxin;ZHOU Honglei(Shandong University of Traditional Chinese Medicine,Jinan 250355,Shandong,China)

机构地区：[1]山东中医药大学,山东济南250355

出　　处：《中华中医药学刊》2021年第4期171-175,I0055-I0057,共8页Chinese Archives of Traditional Chinese Medicine

基　　金：山东省重点研发计划(2017GSF19105);山东省自然科学基金(ZR2015HM080);山东中医药大学药学院“药苑育研”优秀研究生创新基金(YXY20190104)。

摘　　要：目的优化莱菔子总碱渗透泵片的制备工艺。方法在单因素实验的基础上,以莱菔子总碱的释放度为考察指标,采用Box-Behenken响应面法,考察渗透压活性物质、致孔剂用量和包衣增重对释放度的影响,筛选莱菔子总碱渗透泵片的最优处方。结果以37.50%氯化钠、17.50%微晶纤维素、20.00%羧甲基纤维素钠为片芯,以醋酸纤维素∶聚乙二醇400比例为1∶5的包衣液,包衣增重3.50%为最佳制备工艺。结论莱菔子总碱渗透泵片成型工艺安全可靠,重复性良好。Objective To optimize the preparation process of Raphani Semen total alkaloids osmosis pump tablets. Methods Based on the single factor experiment, the release rate of Raphani Semen total alkaloids was used as the index. The Box-Behenken response surface method was used to investigate the effect of osmotic pressure active substance, porogen dosage and coating weight gain on the release rate,so as to screen the optimal prescription of Raphani Semen total alkaloids osmotic pump tablets.Results Taking 37. 5% sodium chloride,17. 5% microcrystalline cellulose and 20. 0% sodium carboxymethyl cellulose as the core,the coating solution with 1 ∶ 5 as the ratio of cellulose acetate to polyethylene glycol 400 and coating weight gain of 3. 5%,this is the best preparation process. Conclusion The forming process of Raphani Semen total alkaloids osmotic pump tablets is safe and reliable,and the repeatability is good.

关 键 词：莱菔子总碱 渗透泵片 Box-Behenken响应面法 

分 类 号：R284.1[医药卫生—中药学]