ABSTRACT
Objective To optimize the prescription of dry granulation process of Anti-Hashimoto’s Thyroiditis Formula Granules. Methods Regarding primary formation rate, friability, and dissolubility and comprehensive in granulation process as indexes, the physical properties of water content, the angle of repose and the degree of compression were investigated to select dry granulation prescription. The technological parameters including horizontal speeds, rotate speed of roller and pressure rollers were screened by L9(34) orthogonal experiment were composed to be optimal technological prescription, and the optimum process was verified. Results The optimum lubricant and accessories ratio were 0.5% magnesium stearate and 20% dextrin respectively. The optimized dry granulation process parameters: horizontal speed 30 r/min, press roll speed 5 r/min and press roll pressure 7 MPa. Conclusion The optimized dry granulation preparation technology is feasible and reasonable, which shows good flakes continuous and granules with color uniformity, suitable rigidity and well formability in dry granulation preparation. After three batches of pilot-scale test, the dry granulation preparation technology is stable and feasible.