Study On Quality Assessment And Analytical Method And Serum Pharmacochemistry In Glucoside Tripterygium Total

Objective…Glucoside Tripterygium Total (GTT)is the nonsteroidalimmunosuppressive drugused in clinical widely and affected by his side effects. Thetopic regardsGTTof different manufacturers and the same manufacturers of differentbatches as the research object to study theproblems in production, which is in order tocarry out quality assessment study and serum chemistry study so as to offfer somebasis for safety and efficacy of clinical medication.Methods…On the basis of the speciality of Ultra Performance LiquidChromatography (UPLC)describeschromatographic composition peak, qualityevaluation, pharmacokinetics and Serum Chemistry of GTT.The specific method is asfollows:①With appropriate UPLC conditions, to describedifferencesofChromatographic composition peak from different manufacturers and the samemanufacturers of different batches of GTT;②UPLC is used to measure peak area ofTriptolide and Wilforlide A of GTT to set up standard curve and calculate thecomponent content with the purpose ofcomparative content differencesof differentmanufacturers and the same manufacturers of different batches of GTT;③Seting upjugular vein intubation model in rats, it isappliedto the preliminary experiment ofpharmacokinetic using for the determination of plasma drug concentration of differenttime;④On the basis of serum drug chemical theory, establishing the chromatogram ofblank serum, standard (Triptolide) serum, mixed suspension serum and test of serumis to compare and analyze differences of peak after composition into the blood.Results…①By means of the comparison of the composition of chromatograms, thenumber of peaks of GTT of the same manufacturers of different batches is notobviously different and the peak area has a certain difference, however,there is a bigdifference in the number of GTT of different manufacturers. Removing the influence of the solvent peak and on the basis of unimodal area is greater or equal to1%, themanufacturer A has most of peaks with seventy-eight but the manufacturer B ownsleast of peaks with fifty-seven. According to the relative retention time, there are tencommon peaks in five manufacturers;②To calculate content by standard curve, thecontent of Triptolide of GTT of the same manufacturers of different batches is notobviously different and the highest content is the lowest content of1.4times.However,there is a big difference in the content of Triptolide of GTT ofdifferent manufacturers and the content of Triptolide of the manufacturer E isseventeen times more than the manufacturer B and the manufacturer D.At same thetime, the content of Wilforlide A of GTT of the same manufacturers of differentbatches and different manufacturers has a small difference, whose times is between1.4to2.2. With the comprehensive comparison, the content of TriptolideandWilforlide A of GTT of manufacturerA, manufacturer C and manufacturer Eis similarand manufacturer A in the middle, then all is more than manufacturer B andmanufacturer D;Everything statesthat the quality of GTT is not stable;③We cannotfound that there are some obstacles in the Pharmacokineticsreach of GTTthoughpreliminary experiment;④Serum medicinal chemistry research of GTT shows thatTriptolide be included in the rat sample serum, which enters into the blood in the formof prototype, and there are other pharmaceutical ingredients in the blood, which areneed to be authenticated.Conclusion…This topic established a comprehensive quality assessment and serummedicinal chemistry research methodslay for the foundation of the study of qualityassessment and serum medicinal chemistry:①In vitro studies indicate that both thenumber of peaks and the content of GTT of of the same manufacturers of differentbatches and different manufacturers have differences and their dose-effect relationship,so it is necessary to limite strictly index composition range of the quality standard ofGTT and consistency of the raw material and the production process.②Withoutfounding some obstacles in the pharmacokineticsreach of GTTthough preliminaryexperiment, we need to continue to study and explorate it from all sides such as thechoice of subjects,the determination of dose, the improvement of Chromatographicconditions and so on;③On the contrary,serum medicinal chemistry research shows that both content and components into the blood of GTT of different manufacturersare also different, which is one of some case causing adverse reactions by GTT undersuspicion. It is adviced to ensure other components in the blood. All of the aboveresearch provide new ideas for the research and development of GTT. So this topicestablishes a relatively comprehensive quality evaluation method of GTT, whichsettles a solid foundation for the quality evaluation of GTT.