The Toxicology Study Of PeiYuan Anti-Tumor Agent

Objective: Give SD rats Pei Yuan Anti-tumor Agent by gastric perfusion. Provide scientific basis for the safety evaluation of Pei Yuan Anti-tumor Agent granules according to the maximum dosage experiment and long term toxicology experiment.Methods: Acute Toxicity Research: According to gender and body weight,20 SD rats were randomly divided into control group and test group. Each group had 5 male and 5 female rats. Pei Yuan Anti-tumor Agent were dissolved in water. The concentration of the water is 4.4g/ml.One kilogram of body weight give every milliliters of the water. The rats in test group were given that water 4 times per day with an interval of 4 hours by gastric perfusion. Rats in control group were given NS. One kilogram of body weight give twenty milliliters of NS. Rats were fasted for three hours after administration. Observed the appearance, hair color, behavior activity and stool of the rats. If found dead or dying rats, timely autopsy. Recorded rats weekly weight and feed consumption, continuous the observation of to the 14 th day. Chronic Toxicity Research: According to gender and body weigh, 80 SD rats were randomly divided into 4 groups. Control group and high, medium and low dose group. Each group had 10 male and 10 female rats. Pei Yuan Anti-tumor Agent dispensing granules were dissolved in water. Gave the rats in high dose group the water of which the concentration is 1.3g extract/ml. The medium group is 0.67 g extract/ml and the low group is 0.33 g extract/ml. Gave the water of different concentrations to the rats in different groups 2 times per day with an interval of 5 hours by gastric perfusion. O ne hundred grams of body weight give every 1 milliliters of the water. Weighing weight once every six days. Change the dose depending on that weight. Gave the rats in control group the same volume of NS. After administration, observed the appearance, hair color, behavior activity and stool of the rats. If found dead or dying rats, timely autopsy. Accorded feed consumption once every six days. After 60 days of continuous administration, sacrificed 5 male and 5 female rats in each group. The remaining rats in each group were sacrificed after 30 days observation without administration. Detected blood routine and blood biochemistry. Calculated viscera index. Observed the organs and tissues of the rats by eyes and under the microscope.Results: Acute Toxicity Research: During the trial, rats were good overall condition. No rats death and no significant toxicity. Within one hour after administration, the locomotor activity of the rats decreased. Body weight and food consumption of the rats were statistically treated. The control group and the test group showed no significant difference. Chronic Toxicity Research: During the trial, rats were good overall condition. No rats death and no significant toxicity after administration. Body weight, food consumption, blood routine, blood biochemistry, viscera index were statistically treated. Four groups showed no significant difference. Observed the organs and tissues of the rats by eyes and under the microscope, found no significant lesions.Conclusion: Gave SD rats Pei Yuan Anti-tumor Agent by gastric perfusion. The maximum dose is 88g/kg. It's twenty times the maximum clinical dose that people taking. No significant toxicity after administration. Long-term toxicity experiment on rats has non-toxic damage and delayed toxicity.