正交试验法筛选氢溴酸右美沙芬颗粒的制粒工艺

Granulating process of dextromethorphan hydrobromide particles with orthogonal experiment method

目的:通过改变黏合剂的浓度、用量和搅拌时间等制粒工艺,进一步优化湿法制粒参数,提高制粒收率。方法:通过糖浆浓度(A,50%、60%、65%)、糖浆加入量(B,200、250、300g)、搅拌时间(C,6、8、10min)等湿法制粒工艺参数为研究因素水平,采用正交试验法以制粒收率为考察指标,优化筛选氢溴酸右美沙芬颗粒黏合剂浓度、用量和搅拌时间,进一步优化湿法制粒工艺参数。结果:正交试验法比较各因素考核指标之和的极差大小,得出最佳工艺为A3B3C3,即65%糖浆300g,搅拌10min的工艺参数进行湿法制粒,经放大3批样品工艺研究,可提高氢溴酸右美沙芬颗粒的制粒收率。结论:以65%糖浆300g为黏合剂,搅拌时间10min为湿法制粒工艺,可以提高氢溴酸右美沙芬颗粒的制粒收率,工艺可行。

Objective：To improve the granulating process of making dextromethorphan hydrobromide particles for optimized wet granulation parameters and higher granulation yield by changing concentration of binding agent,dosage and mixing time.Methods：Different syrup concentration（A,50%,60%,65%）,syrup dosage（B,200,250,300g）,mixing time（C,6,8,10min） and other parameters were applied for granulating process of dextromethorphan hydrobromide particles with orthogonal experiment method.Results：The result showed A_3B_3C_3 was the optimum parameters for granulating process of dextromethorphan hydrobromide particles with orthogonal method,specifically,65% syrup 300g,10 min stirring for wet granulation can increase the yield.Conclusions：The wet granulation process that takes 65% syrup 300 g as binding agents and stirring time of 10 min can increase the granulation yield of dextromethorphan hydrobromide particles and it is feasible.