Pulse Injection And Injection Refs Health Human Pharmacokinetic Studies

Purpose:To study the bioavailability and pharmacokinetics (PK) betweenShengmai injection and shenmai injection on random-cross method.Material and method: The random allocation and monocyclic design wasemployed. The proper16healthy femal subjects were divide into2groups treatingwith the same dosage of target injection (60ml of Shengmai injection and100mlof5%glucose injection), and reference injection (60ml of Shenmai injectionand100ml of50%glucose injection) for parallel control,8subjects in eachgroup.5ml of blood was draw at the following time points: before the injection,0.5h and1h after the injection,0h,0.083h,0.25h,0.5h,1h,2h,3h,4h,5h,6h,8h,12h,24h,48h,96h,144h after the injection ends. The plasma wasseparated through centrifuging blood samples (3500rpm) for10mins, then storedat-70°C. The DAS ver2.1and SPSS17was applied to analysis PK parameters.The HPLC-MS was employed to assay drug concentration without edogenous andmetabolin interference.Results:The determination was operated without endogenous substance andmetabolin interference. Linear range of ginsenoside Rg1、Re、Rb1and Schizandrolrespectively was0.635-509、0.625-501、1.18-4725and0.102-153.3μg·L-1, theLLole respectively was0.635,0.625,1.18and0.102μg·L-1(S/N>10); bloodplasma sample recovery was more than60%; method relative standard deviation(RSD%) was less than15%, relative standard (RE%) was between±15%. Theestablised assay method was suitable for biological sample analysis, and meetsthe need of PK research on Shengmai injection and Shenmai injection. There isno significant differences between the two injection in PK paramters, on themethod that logarithm transformation on AUC0-tand Cmax, analysis of variance onother paramters (t1/2、CL、V、MRT), as well as, non-parametric test ontmax. Theresults from SPSS17.0indicate there is no significant differences in PK paramters of ginsenoside Rb1between the two injection through the test, butRg1and Re, which is only in Cmax、CL、AUC0-t、AUC0-∞,except other parameters.Conclusion:There is bioequivalence between Shengmai injection and Shenmaiinjection in ginsenoside Rg1and Rb1; There is obviously significant differencesin PK paramters (Cmax、CL、AUC0-t、AUC0-∞) of ginsenoside Rg1and Re between thetwo injection through t test. The internal drug concentration of Shengmaiinjection is far more higher than Shenmai injection; the efficacy time ofShengmai injection is longer than Shenmai injection, for the reason that theremoving time is longer with significant differences. Consequently, from theview of PK, the clinical efficacy of Shengmai injection is superior to Shenmaiinjection. Meanwhile, it also demonstrates that the compatibility principle ofChinese medicines is rational.