Studies On Pharmacokinetics And Safety Of Compound Yimucao Injecta

With the development of concentrated cultivation, incidence rate of postpartum disease had been increased and it became severe diseases which harmed the development of cultivation industry. Natural Chinese medicine was confined to utilize because of its quality standard, medicine metabolism research and more clinic side-effects. The studies on pharmacokinetics and safety of compound yimucao injecta were to ensure its safety and effectivity. The study would provide scientific theory for clinics study and basis for new animal medicine preparation.According to new medicine regulation, pharmacokinetics of compound yimucao injecta main components- stachydrine, forsythin and ligustrazine in rats'plasma was studied by High Performance Liquid Chromatography and the safety was evaluated via acute toxicity experiment, safty dose experiment, subchronic toxicity experiment, pyrogen experiment, allegic experiment and stimulation experiment. The results showed:1. Injected rats with compound yimucao injecta, the concentration–time course of stachydrine in rats'plasma could be described by a two-compartment open model with first order absorption, the main pharmacokinetic parameters were as follows: t1/2ka=0.15017h, t1/2α=0.20701h, t1/2β=3.14613h, k12=1.24602h-1, k21=0.37966h-1, kel=1.94218h-1. The concentration–time course of forsythin and ligustrazine in rats'plasma could be also described by a two-compartment open model with first order absorption, the main pharmacokinetic parameters were as follows: t1/2ka=0.15179h, t1/2α=0.20171h, t1/2β=3.11458h, k12=1.22349h-1, k21=0.37030h-1, kel=2.06435h-1; t1/2ka=0.14896h, t1/2α=0.20659h, t1/2β=7.33190h, k12=1.64715h-1, k21=0.19764h-1, kel=1.60427h-1. These showed that compound yimucao injecta was absorbed quickly, spread to each organ and eliminated slowly.2. Compound yimucao injecta oral LD50 was more than 76.082g/kg BW and injected LD50 was more than 19.175g/kg BW in rats'acute toxicity experiment; mice's tolerance dose was as more three hundred times than practical animal's dose; There was no toxic reaction in subchronic toxicity experiment. The results of pyrogen test, supersensitivity and stimulus experiment accorded with injecta standard. These showed compound yimucao injecta was safe.and reliable.