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| Study on acute toxicology and long-term toxicology of Yiqi Xingnao Oral Liquid |
| PANG Tao1 CHEN Jikuai2 PIAO Shujuan1 ZHU Jiangbo2 LU Wenquan1 |
1.Department of Pharmacy, Changzheng Hospital, the Second Military Medical University, Shanghai 200433, China;
2.Drug Safety Evaluation Center, the Second Military Medical University, Shanghai 200433, China |
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Abstract Objective To observe and evaluate the reaction of acute and long-term toxic of Yiqi Xingnao Oral Liquid, and to provide a secure basis for the clinical application. Methods Fifty ICR mice were randomly divided into the solvent control group, group A, group B, group C and group D by completely random method in the acute toxicology experiment. With 10 mice and with half male and half female in each group. Solvent control group was given deionized water, the other groups were respectively given Yiqi Xingnao Oral Liquid, with group A (2280 g/kg), group B (1710 g/k), Group C (1282 g/kg) and Group D (962 g/kg). The physiological changes and the death rate of mice in each group were observed, and the lethal dose 50% (LD50) was calculated. One hundred and twenty SD rats were randomly divided into solvent control group, low doses group, medium doses group, and high doses group. With 30 mice and with half male and half female in each group. Solvent control group was given deionized water, low, medium, high dose groups were respectively given Yiqi Xing nao Oral Liquid with 90, 180 and 360 g/kg. Continuous administration for 91 days and recovery for 28 days. The animals′ general symptoms, weights, food intakes, blood routine, blood biochemistry and the major organs histopathology (heart, liver, spleen, kidney, brain) in high dose groups were observed after administration and during convalescence. Results The acute toxicology results showed that the mortality rate of each group was 90% in group A, 70% in group B, 10% in group C, and none in group D. LD50 was 1630.9 g/kg, and the 95% confidence limit was 1427.2-1863.7 g/kg. The long-term toxicity results showed that the general symptoms of the rats in each dose group were normal. Compared with the solvent control group, the weight gain of male rats in high dose group were significantly lower from week 4 to week 17 (P ＜ 0.05), and the food intake decreased significantly from week 3 to week 15 (P ＜ 0.05). There was no significantly difference of weight gain and food intake in other groups (P > 0.05). The blood routine and blood biochemical indexes of each group of rats were within the normal physiological range. Compared with the solvent control group, the sections of heart, liver, spleen, kidney and brain were normal in the high-dose group. The safety dose of Yiqi Xingnao Oral Liquid was 180 g/kg, and that was 48 times of the clinical dose. Conclusion Yiqi Xingnao Oral Liquid has no drug-related toxic effect on two kinds of rodents, which has high tolerance, small side effects, large safety window and high clinical safety.
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