Liu Dan, He Feng-Jun, Liu Chang-Long, Liu Jun-Chao, Wu Yun, Wang Zhen-Zhong, Xiao Wei
Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China.
State Key Laboratory of Pharmaceutical Process New-teach for Chinese Medicine, Lianyungang 222001, China.
Zhongguo Zhong Yao Za Zhi. 2016 Jan;41(1):75-82. doi: 10.4268/cjcmm20160115.
To optimize the one-step pelletization technology of Fuke IV (FKIV) granules by response surface methodology. With the qualified rate of granules as evaluation indexes, 6 factors affecting one-step pelletization technology were investigated, significant levels of each factor were evaluated and the primal influential factors were determined by Plackett-Burman experimental design. According to the Plackett-Burman experimental design, the qualified rates of granules, moisture capacity and angle of repose as the evaluation indexes, Box-Behnken design with three levels and three factors was established for quadratic regression fitting of the models. Then the experimental results were optimized by Response Optimizer. The best process conditions were determined as follows： the extract relative density of 1.20, inlet air temperature of 88 ℃, and atomization pressure of 0.28 MPa. FKIV granules were prepared by the optimized experimental scheme. The determined qualified rate, moisture capacity and angle of response were 93.65%, 3.76% and 23.19° respectively for the granules, basically similar to the predicted values, indicating that the optimal process conditions were in line with the manufacturing requirements.
