响应面法优化芪白平肺颗粒干法制粒工艺

为了确定芪白平肺颗粒的最佳制粒工艺条件,该研究考察了辅料、送料速度、轧轮转速、轧轮压力对干法制粒工艺的影响。以颗粒一次成型率、吸湿性和溶化性为指标确定了辅料种类及用量,再通过单因素考察试验并结合Box-Behnken响应面法,以送料速度、轧轮转速、轧轮压力为自变量,颗粒一次成型率为因变量,优化干法制粒工艺参数,得到芪白平肺颗粒最佳工艺条件为:稀释剂乳糖最佳比例为干浸膏-乳糖 1:2;轧轮压力6.4 MPa、轧轮转速10.9 Hz、送料速度7.2 Hz。通过3批放大工艺验证,显示优化后的工艺参数制备出的芪白平肺颗粒具有成型率高、溶化性好、吸湿率低等优点。结果表明芪白平肺颗粒干法制粒优化后的工艺参数合理、可行、重复性好,为以后该产品产业化应用提供依据。

Optimization of dry granulating technique of Qibai Pingfei granule through response surface methodology

To determine the optimum process conditions for dry granulating technique of Qibai Pingfei granule, granule excipient type, rolling wheel speed and pressure and feeding speed were studied. Taking shaping rate at a time, moisture absorption and dissolubility as index, the type and amount of granule excipient were determined. In addition, taking shaping rate at a time as index, parameters of rolling wheel speed and pressure and feeding speed were researched through single factor test and response surface methodology. The optimum parameters were as follows: lactose as excipient, dry extract powder to excipient at 1:2, rolling wheel speed and pressure at 10.9 Hz and 6.4 MPa and feeding speed at 7.2 Hz. After validation of three batches pilot-scale production, the optimum processing parameters for dry granulating technique of Qibai Pingfei granule is reasonable and feasible, which can provide reliable basis for production.