Study On The Effective Ingredients Of Psoralea Corylifolia In Bufeihuoxue Capsule

Objective We studied the material basis of psoralen in bufeihuoxue capsule with pharmacy and pharmacokinetics point of view and optimized psoralen extraction and purification process using the main component elements of matter as an index. A draft quality standard of psoralen extract was established, laying the foundation for the development of bufeihuoxue capsule.Method HPLC method was used to study the fingerprints of psoralen extract. A rat situ single pass perfusion model was established to clarify the psoralen reduction in perfusion fluid and infiltration of each ingredient into the blood. The rat model in vivo was used to study the blood composition after oral administration, urinary excretion and fecal excretion component composition. The absorbed component of psoralen extract was analyzed by a combination of the above two models, which was the material basis of psoralen. Optimize the extraction process of psoralen with the orthogonal experimental design, using the material basis as an index. Establish the enrichment method for psoralen extract purification. Develop a quality standard according to the general requirements for new drug development.Result Chromatographic conditions are listed following:Kromasil C18 (250×4.6mm,5μm) column; Mobile phase:methanol-water phase (containing 0.1% formic acid, lOmmol·L-1 ammonium acetate), gradient elution; flow rate:1.OmL·min-1;detection wavelength:245nm,320nm. Various psoralen components separated well under the chromatographic conditions above, and precision and stability test results were well.Four kinds of main components of psoralen extract were absorbed to varying degrees in intestinal perfusion experiments.After oral administration, these components were also detected in SD rat blood, urine samples. Fecal extracts of these components were relatively less than the extract. Confirmed by the structure, they are psoralenoside, isopsoralenoside, psoralen, isopsoralen, respectively, which established the material basis of psoralen in bufeihuoxue capsule. So these components were served as the index of optimization process of extraction and purification. Optimal extraction process of psoralen:using 8 times,7 times the amount of 60% of ethanol extracted twice, each 1.5 hours. Optimal purification process: using D101 macroporous resin as a filler and the liquid concentration of extract was 0.5g mL-1,the sample was 1BV, adsorption flow rate was 1 2 mL·min-1.After 2h adsorption, used 3 BV water to impurify,7 BV 70% ethanol to elute target composition. Then the eluate was collected and dried to powder. Quality study focused on character, identification, determination of target components, inspection and other aspects of research. A draft quality standard of psoralen extract was established.Conclusion We partly clarified the material basis of psoralen in bufeihuoxue capsule and optimized its extraction and purification process. We developed the psoralen extract quality standards so as to further the foundation for development of bufeihuoxue capsule.