中心组合设计法响应面法优化宣肺解毒胶囊填充工艺

Optimization of the capsule filling process of Xuanfei Jiedu capsule with central composite design-response surface method

目的:采用中心组合设计法(Central Composite Design,CCD)响应面法优化筛选宣肺解毒胶囊最佳填充工艺。方法:以药粉过筛数目、料斗加药量、空气相对湿度及转盘速度为考察因素,以胶囊装量为考察指标,采用Design-Expert 8.0.6.1软件进行CCD响应面试验设计,建立多元线性方程并绘制考察因素交互影响的响应面图,优化宣肺解毒胶囊装量为0.4800 g~0.5100 g间的最佳填充工艺并进行验证。结果:宣肺解毒胶囊最佳填充工艺为药粉过筛数目80目,料斗加料量64%,空气相对湿度54%,转盘速度9.27 s/盘,得胶囊装量最小为0.4801 g,最大为0.5100 g,平均胶囊装量0.4937 g,标准偏差0.008,与预测值偏差1.67%,所建立的数学模型预测性良好。结论:CCD-响应面法所筛选的宣肺解毒胶囊最佳填充工艺稳定,可满足大批量生产的实际需要,具有较强可行性。

Objective:To optimize the capsule filling process of Xuanfei Jiedu capsule(宣肺解毒胶囊)by central composite design-response surface method.Methods:The number of powder sieving,the amount of powder added in the hopper,the relative humidity of the air and the speed of the turntable were taken as the investigation factors,the quantity of capsule was taken as the index,the CCD response surface test was designed by using design-Expert 8.0.6.1 software,multiple linear equations were established and effect surface maps were drawn to investigate the interaction between factors.The optimal filling process of Xuanfei Jiedu capsule with the loading amount of 0.480,0-0.510,0 g was optimized and verified.Results:The optimal filling technology of Xuanfei Jiedu capsule was sieve number of powder 80 mesh,hopper feeding volume 64%,air relative humidity 54%,rotating speed 9.27s/plate,minimum and maximum capsule loading was 0.480,1 g and 0.510,0 g respectively,average capsule loading was 0.493,7 g,standard deviation was 0.008,and 1.67%from the predicted value.The established mathematical model had a good prediction.Conclusion:The optimal filling process of Xuanfei Jiedu capsule screened by CCD-response surface method is stable,which can meet the practical needs of mass production and has strong feasibility.