Abstract: To evaluate clinical safety of Qishen oral solution, tests of acute toxicity and chronic toxicity were made according to toxicological evaluation procedures and methods. During the acute toxicity test, 40 Kunming mice were randomly divided into 2 groups. The maximum tolerable dosage of Qishen oral solution was determined by intragastric administration in mice. During the chronic toxicity test, Wistar rats were randomly divided into 4 groups, and the three experimental groups were given Qishen oral solution in doses of 3.75,7.5,15 g/kg by intragastric administration for 4 weeks, once a day, and observed after stopping administration for 2 weeks.The control group was given the same amount of physiological saline.The chronic toxicity were assessed on rats through recording daily water intake, feed intake and weekly body weight, measuring hematologic and blood biochemical indexes after administration for 4 weeks and withdrawal for 2 weeks. The results showed that the maximum tolerable dosage of Qishen oral solution administration was 40 g/kg in mice.It was equivalent to 40 times of the dosage used in clinic.Daily feed intake and water intake for some administration group showed significant (P＜0.05)or extremly significant (P＜0.01) differences compared with that in the control group, but average weekly gain had no significant changes (P＞0.05); during 4 weeks of intragastric administration, some indexes of hematology appeared significantly (P＜0.05) or extremly significantly (P＜0.01) different from that in the control group, but after 2 weeks, they had no significant changes (P＞0.05); blood biochemistry,viscera index and histological examination had no significant difference (P＞0.05). In conclusion, the clinical medication of the oral liquid was safe under this experimental condition.

Key words: Qishen oral solution; acute toxicity; chronic toxicity