Based On Material Properties And The Similarity Factor Method To Investigate Effect Of Vitro Dissolution Of Tongmai Pill In Different Material Extraction Ratio

Objective: To discuss the effect of vitro dissolution of tongmai pill in three differentmaterials extraction ratio, to fit the dissolution curve of tongmai pill; to optimize the best extraction conditions of pongmai pill and to validate the effects of different material on pilldissolution based on the results of data analysis.Methods: To use HPLC method, the similarity factor, AHP(Analytic hierarchy process)and to combine "medicine auxiliary unified " theory. To use tongmai pills as a model drug,the extract different proportions medicinal herbs are extracted by using uniform design table(U6(64)). The method of extracting is as follows:12times amount of40%ethanol,extracting2times and140minutes every time, the ethanol extracts were recovered todryness under reduced pressure.Then the dry extract were crushed, mixed with smashedand sifted herbs, and made into pelleting in a generic way:80%ethanol as a binder,at40rpm, added amount of binder at0.35ml.g-1’s.HPLC method, using900ml pH7.0water treating with ultrasonic30min as dissolutionmedium, selecting the slurry method, at the speed100r.min-1,37℃,dosage of10g, sampling10ml in2,5,10,20,30,40,60,120,240,1440minutes after administration,respectively, instanttop-up liquid, centrifuge dissolution,add methanol to9ml supernatant in a constant volumeof10ml flask, and shake it well.HPLC method,determining the content of the strychnine, brucine, paeoniflorin andferulic acid,acid B,hesperidin, benzoyl new aconine and Raddeanin A, benzoicchromatographic conditions and acyl new aconine for Raddeanin a: Column Agilent SB-AQ(4.6x250mm,5μm), mobile phase: acetonitrile-0.1%phosphoric acid gradient. Strychnine,brucine, paeoniflorin and ferulic acid, acid B, hesperidin chromatographic conditions were:column Agilent SB-AQ (4.6mm x250mm,5μm),mobile phase: acetonitrile-methanol-0.1%phosphoric acid gradient. Chemical parameters were measured to establish the above ingredients methods.The content of strychnine, brucine, paeoniflorin and ferulic acid, acid B, hesperidin,benzoyl new aconine content and Raddeanin A at different time of taking sample aredetermined using the HPLC method. Real-time concentrations, the rate of dissolutiondifferent extraction ratio of the tongmai pill dissolution fluid tongmai pill and cumulativedissolution are determined.The single ingredient and comprehensive evaluation of thedissolution profile and the corresponding dissolution profile are drew, correlation comparedfull of pink medicine tongmai pill is evaluated using similarity factor f2, and the "medicineauxiliary unified " theory is validated.Model is stabled using Excel, Matlab, Weibull distribution model, SMR method anddifferent sample extraction ratios of cumulative dissolution rate are analyzed.The effectsStarch,fiber,fats and oils of different categories of materials extraction ratio on T40(therequired time of the sample cumulative dissolution is40%) are analyzed,and then the effectsof the dissolution of the three types of materials on dissolution are deduced.Results:the dissolution rate of Ning,strychnine,paeoniflorin and ferulic acid, acid B,hesperidin disabilities, benzoyl new aconine and Raddeanin A change with the extractionratio changes. The dissolution profile of complete fat powder tongmai pill and tongmaisimilarity factor f2are greater than50,that is,dissolution profile of the extraction ratio oftongmai pill is similar to the tongmai dissolution curve;using SMR method the modelsbetween T40and any two types material are established,and then the relationship betweenthem is deduced. The results has shown negative correlation between the extraction ratio ofstarch and fiber and the dissolution rate, that is, starch and fiber promote activity dissolution,positive correlation between the extraction ratio of fat,that is, fat prevent dissolution.Conclusion:The method based on the material properties and the similarity factor can beused to screen extract the ratio tongmai pill;when the extraction ratio of fats and oilsextracted is0%,extraction ratio of starch and fiber are80%and40%of tongmai pill,tongmai pill and tongmai are bioequivalent; starch and fiber promote activity dissolution andfat prevent dissolution.