Abstract:Objective To determine the optimum granulating process conditions of Radix Isatidis granules,and to investigate the influence of auxiliary material,feeding speed,rolling speed and roller pressure on dry granulation technique.Methods Taking the rolling wheel speed and pressure and feeding speed as the independent variable,the shaping rate and dissolubility as the dependent variable,the parameters for Isatidis Radix dry granulation were optimized and validated through response surface methodology.Results The results of the statistical model showed that rolling wheel rate and feeding rate were the key variables which had significant impact on the properties of Isatidis Radix granules.The optimum parameters were identified as follows,feeding rate at 50 r/min (X1),rolling wheel rate (X2) at 8 r/min and pressure (X3) at 15 MPa.The three scaled-up batches of validated experiments showed that the granules manifested higher shaping rate at one time and lower dissolution time (80.88% and 14.3 min,respectively).Based on the data obtained from predicted values and measured values,the model showed good prediction ability and accuracy.Conclusion The approach of response surface methodology applies to investigate and optimize dry granulation of Isatidis Radix is feasible and reasonable.The model is robust and high predictble to provide reliable basis for production.
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