RESUMEN
Objective: To study the prescription and process of Fritillariae Thunbergii Bulbus (FTB) formula granules. Methods: FTB was extracted by decocting method. FTB extract powder was prepared by spray drying method. Wet-extruding granulating, extruded-rolling granulating, and one-step granulating were adopted for preparing the formula granules. A comprehensive evaluation method was based on the powder fluidity parameters such as the rest angle, the final volume reduction degree (a), the filling velocity constant (b, k), and the yield of the particles, to optimize the optimum preparation process, prescription excipients and their proportion. An HPLC method was used to determine the contents of peimine and peiminine. The chromatographic column was the Agilent Zorbax Eclipse XDB-C18 column (150 mm × 4.6 mm, 5 μm), and the flow phase was Acetonitrile-water-diethylamine (70:30:0.03); The volume flow was 1.0 mL/min; The column temperature was 30 ℃. Results: The synthesis score of the FTB formula granules prepared by one-step granulating method was the highest. The best prescription was the extract powder-dextrin- 95% ethanol solution (100:100:160). The particle yield was 91.3%, the rest angle was 30.73°, the value of a was 0.109 1, the value of b was 0.025 5 and the value of k was 0.030 1, the fluidity of the granules was good and the yield was high. The content of peimine was 0.305% and the content of peiminine was 0.098% in the particles by HPLC. Conclusion: In this experiment, the formulation and process of FTB formula granules were designed to met the design requirements, which could be used in the production of the technology.