ABSTRACT
The "design space" method was used to optimize the purification process of Resina Draconis phenol extracts by using the concept of "quality derived from design" (QbD). The content and transfer rate of laurin B and 7,4'-dihydroxyflavone and yield of extract were selected as the critical quality attributes (CQA). Plackett-Burman design showed that the critical process parameters (CPP) were concentration of alkali, the amount of alkali and the temperature of alkali dissolution. Then the Box-Behnken design was used to establish the mathematical model between CQA and CPP. The variance analysis results showed that the P values of the five models were less than 0.05 and the mismatch values were all greater than 0.05, indicating that the model could well describe the relationship between CQA and CPP. Finally, the control limits of the above 5 indicators (content and transfer rate of laurine B and 7,4'-dihydroxyflavone, as well as the extract yield) were set, and then the probability-based design space was calculated by Monte Carlo simulation and verified. The results of the design space validation showed that the optimized purification method can ensure the stability of the Resina Draconis phenol extracts refining process, which would help to improve the quality uniformity between batches of phenol extracts and provide data support for production automation control.
ABSTRACT
Objective To optimize refinement of water extract from Bushen Yangxue Granules by chitosan flocculation.Methods According to the content of icariin detected by HPLC, the waters amount, extraction time and extraction times were evaluated by orthogonal design. The effects of the solution concentration, clarifying temperature and the amount of clarifying agent on the flocculation clarification processes were optimized with the content of icariin and polysaccharides.Results The optimum water extraction processes A2B1C3 were follows: 10 times amount of water, three times extraction and 1 h for each extraction process. The optimized flocculation clarification processes A1B2C3 were as follows: solution concentration was 0.4 g/mL, the clarifying temperature was 40℃ and the addition of chitosan was 0.1%.Conclusion The optimized refining process is stable and feasible.
ABSTRACT
Objective To evaluate the efficacy of different processes ofBaijin Capsule to treatment of mice with chronic unpredictable stress-induced depression.Methods Chronic unpredictable stress was used to establish depression mice models. Experimental mice were divided into the following groups according to body mass: model group, positive medicine group, artware one (traditional process) high-dose and low-dose groups, and artware (refining process) two high-dose and low-dose groups. All medication groups were given relevant medicine for gavage. By detecting the two behavior indexes, immobility time of swimming and tail suspension of mice, the anti-depression effects of traditional process and refining process ofBaijin Capsule were investigated. By detecting autonomic activities and body mass, tested medicine was examined for function state of central excitation and changing animal body.Results The times for automatic activities ofBaijin Capsule in the model and artware (refining process) two high-dose and low-dose groups were (138.27±40.70)s, (100.01±34.75)s and (88.15±30.62)s, respectively, with statistical significance (P<0.01); the mice swimming immobility times in the model and artware (refining process) two low-dose groups were 668±19 and 705±24, respectively, with statistical significance (P<0.01); the mice tail suspension immobility times in model and artware (traditional process) one high-dose groups group were (28.14±1.25)g and (26.43±2.58)g, respectively, with statistical significance (P<0.05); the mice tail suspension immobility times in model and artware (refining process) two high-dose groups were (98.29±36.90)s and (87.54±30.05)s. Mice tail suspension immobility time in artware (refining process) two high-dose group decreased,without statistical significance.Conclusion Refining process ofBaijin Capsule can effectively be used to treat mice with chronic unpredictable stress-induced depression, and the efficacy is superior to the traditional process.