ABSTRACT
Objective: The optimum technological conditions of granule dry granulation of Wenshen Zhuanggu Granule (WZG) were optimized to improve production efficiency and ensure product quality and curative effect. Methods: The difficulty degree of granulation was studied by orthogonal test. The molding rate and the dissolved property of the granule determined the type and dosage of excipients for the evaluation index. Through single factor investigation test and combined with Box-behnken response surface method, the feed speed, rolling speed and rolling pressure were the independent variables, and the particle forming rate was dependent variable, in order to optimize process parameters of dry granulation. Results: The optimum proportion of excipients was the dextrin with 1:3 of the dosage of dry paste powder, 1:15 carboxymethy starch sodium, 1:90 of the micro-powder silica gel, the best granulation process for rolling wheel pressure 9.5 MPa, rolling speed 14.0 Hz, and feed speed 13.2 Hz. Through the amplification process validation of three batches, it showed that the WZG prepared by the optimized excipients and process parameters have the advantages of high molding rate, good melting and low moisture absorption rate. Conclusion: The selected process is reasonable and feasible, and it provides technical reference and basis for the industrial application of the product.