Zeng Jia, Ming Liangshan, Wang Jiamiao, Huang Ting, Liu Binbin, Feng Linglin, Xue Man, Chen Jianxing, Du Ruo-Fei, Feng Yi
Innovation Research Institute of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, PR China.
Shanghai Institute of Planned Parenthood Research, NHC Key Laboratory of Reproduction Regulation, Shanghai Engineering Research Center of Reproductive Health Drug and Devices, Shanghai, PR China.
Pharm Dev Technol. 2020 Jul;25(6):720-728. doi: 10.1080/10837450.2020.1738461. Epub 2020 Mar 15.
The objective of this study was to predict the droplet size and the spraying angle during the process of binder atomization in pharmaceutical fluidized bed granulation using an empirical model. The effects of the binder viscosity, the atomization pressure, and the spray rate on the droplet size and the spraying angle were investigated using a response surface central composite design and analysis of variance. Prediction models for droplet size and spraying angle were then established using stepwise regression analysis and were validated by comparing the measured and predicted values. The results showed that the droplet size model and the spraying angle model were well established, with an of 0.93 ( < 0.0001) and a root mean square error (RMSE) of 10.10, and an of 0.82 ( < 0.0001) and an RMSE of 3.69, respectively. The error between the measured and predicted values of the droplet size and the spraying angle were less than 10%, indicating that the established models were accurate. The results of the present study were significant in predicting the droplet size and spraying angle in the process of pharmaceutical fluidized bed granulation.
本研究的目的是使用经验模型预测药物流化床制粒过程中黏合剂雾化过程中的液滴尺寸和喷雾角度。采用响应面中心复合设计和方差分析研究了黏合剂粘度、雾化压力和喷雾速率对液滴尺寸和喷雾角度的影响。然后使用逐步回归分析建立了液滴尺寸和喷雾角度的预测模型，并通过比较测量值和预测值进行了验证。结果表明，液滴尺寸模型和喷雾角度模型建立良好，相关系数分别为0.93（P<0.0001），均方根误差（RMSE）为10.10，以及相关系数为0.82（P<0.0001），RMSE为3.69。液滴尺寸和喷雾角度的测量值与预测值之间的误差小于10%，表明所建立的模型是准确的。本研究结果对于预测药物流化床制粒过程中的液滴尺寸和喷雾角度具有重要意义。
