The Experimental Study On Safety Pharmacology Of Saponins Of Aralia Elata Leaves From Liaodong Capsule

Object:Total saponins of Aralia elata leaves from Liaodong capsule is the traditional Chinese medicine for the treatment of lung cancer,gastric cancer and breast cancer.This test in ICR mice and Beagle dog single oral total saponins of Aralia elata leaves from Liaodong capsule,Observe its effects on motor coordination ability,independent activity in mice,and on breathing,blood pressure and electrocardiogram for Beagle dogs.To evaluate the drug on the central nervous system function,the influence of the cardiovascular system and respiratory function,provide reference for clinical safe drug use.Methods:Choose turn bar experiment and autonomic activities experiment in mice to observe the influence of total saponins of Aralia elata leaves from Liaodong capsule on the nervous system function.The experiment of mice set to solvent control group and the total saponins of Aralia elata leaves from Liaodong capsule high,medium and low three dose groups,dose respectively 100,300,900 mg/kg.Each group of 20 ICR mice,male and female half,single oral dose,dose volume for 20 ml/kg.Before the delivery and 50 min,180 min after dosing,respectively using mice turn bar gauge and the autonomic activities in mice meter test animal rotation rods fall within 5 minutes of time,and within 5 min number of independent activities,as the measurement indicators.The data with mean ± standard deviation(x±s),said the use of SPSS software for the single factor analysis of variance(P<0.05 for significant indicators).Choose remote sensing observation total saponins of Aralia elata leaves from Liaodong capsule on the Beagle dog the influence of the cardiovascular system and respiratory system.Beagle dogs experiment set hollow capsule group and total saponins of Aralia elata leaves from Liaodong capsule high,medium and low three dose groups,respectively 20,60,162 mg/kg.Each group of six animals both male and female half,a single oral dose,hollow capsules group was given capsules grain number is the same as the high dose group.Using noninvasive blood pressure animal ecg telemetry system record the change of the ecg indicators body temperature,respiratory frequency,respiratory intensity and blood pressure before and after dosing.To the end points of 0 min,set to 15 min,30 min,60 min,90 min,120 min,180 min,240 min point in time,with 15 min test indexes as their own controls,and each index compared with their control after the treatment,variance analysis.Results:ICR mice with a single oral total saponins of Aralia elata leaves from Liaodong capsule(dose of 100,300,900 mg/kg),after observing animals to 3 hours,ICR mice were generally in good condition,not seen reactions such as muscle tremors,salivate and vertical hair,breathing in good condition,normal activities.Rotation rod drop time,number of independent activities in mice compared with solvent control group,before delivery,50 min,180 min after the treatment there was no significant difference(P>0.05).Beagle dogs single oral total saponins of Aralia elata leaves from Liaodong capsule(dose of 20,60,162 mg/kg),the observation to 4 hours,high dose group of two male animals were vomiting,retching after taking medicine,the rest of the animals were generally in good condition,appearance and coat,breathing in good condition.RR interphase,heart rate,PR interval period,the P wave schedule,QRS schedule,QT interphase,QTcF,body temperature,respiratory frequency and respiratory intensity,mean arterial pressure,diastolic blood pressure and systolic blood pressure after the treatment in animals in 30 min,60 min,90 min,120 min,180 min,240 min,and 15 min before the drug is no abnormal change(P>0.05).Conclusion:Under this experimental condition,ICR mice single oral total saponins of Aralia elata leaves from Liaodong capsule,dose of 100,300,900 mg/kg,the motor coordination ability,independent activity had no obvious effect.Beagle dogs single oral total saponins of Aralia elata leaves from Liaodong capsule,dose of 20,60,162 mg/kg,high doses can cause individual animals vomiting,there was no effect on the cardiovascular system,respiratory function and temperature.