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.
ABSTRACT
Objective To compare the refining effects between ethanol precipitation and chitosan flocculation methods on extracting solutions of Shuyu compound granules.Methods Orthogonal experiment was utilized to examine the influence of liquid concentration, alcohol concentration and standing time on refining of Shuyu compound granules extracting solution by ethanol precipitation method, and compare the impact of ethanol precipitation and chitosan flocculation methods on the contents of solids and paeoniflorin.Results The optimized condition of ethanol precipitation method was 0.8 g/mL solution concentration (crude drug) with 20% ethanol standing for 6 h. Both ethanol precipitation method and chitosan flocculation method reduced the extraction ratio of Shuyu compound granules decoction, but chitosan flocculation method caused a great loss of paeoniflorin.Conclusion Low concentration ethanol precipitation method can be used for the purification of Shuyu compound granules. Whether chitosan flocculation method is suitable requires further study.