ABSTRACT
Objective To select the optimum process of granule spray for Tangwang Mingmu Granules, To improve the yield and finished product quality. Methods The effects of the relative density, the type of excipients, the ratio of the extract and the excipient, the inlet temperature-the material temperature, the spray rate and the atomization pressure were selected by single factor and orthogonal test respectively to determine the optimum preparation process. Validation for three batch sample, particle flow, hygroscopicity and other related content of the preparation were studied. Results The optimum spray granulation process of Tangwang Mingmu Granules: the relative density of extract (60 ℃ determination) was 1.15–1.20; the excipient was selected as dextrin; the ratio of dry extract and excipient was 58:42; inlet temperature - material temperature was 90-75 ℃; atomization pressure was 0.12 mPa;spray rate was 10 Hz.Conclusion The preparation technology of Tangwang Mingmu Granules optimized in this study is with high preparation rate, good fluidity and hygroscopicity, which can be used for the preparation of Tangwang Mingmu Granules.