Effect of different separation and purification processes on preparation characteristic of gubi granules powder / 中草药

ABSTRACT

Objective: To evaluate the optimal separation and purification processes of water extract, the analytic techniques of particle size analysis, powder fluidity testing, and scanning electronic microscope were adopted to compare the influence factor of different separation and purification techniques on microscopic preparation characteristic of intermediate product prepared from water extract of traditional Chinese medicine (TCM) formula purification. Methods: Taking Gubi Granules (GG) which have established the production technology and quality standards in the previous study as an example, three common techniques used for water extract of TCM formula purification, including ethanol precipitation, column chromatogram of macroporous resin, and membrane separation, were applied to preparing the intermediate of GG. Results: Through the comprehensive analysis of fluidity, adhesive property, compressibility, permeability, particle microstructure and particle size distribution, it was found that membrane separation could obtain intermediates with better performance, which was conducive to the subsequent granulation, tabletting, and other process smoothly. The operating conditions for liquid concentration were 0.05 g crude drug/mL, 30 ℃ liquid temperature, 0.15 MPa pressure and 5 m/s flow rate. Conclusion: The different spray dried powders varied greatly. The membrane separation method of 0.2 μm Al2O3 ceramic was selected as the optimal process for separating and purifying of water extract of GG by analyzing the influencing factors of the pharmaceutical properties.