Abstract: Objective To investigate the chronic toxicity of Qing'e pills in Wistar rats and observe the severity of toxic reactions, involved organs, action characteristics and recovery of experimental animals so as to provide toxicological data for clinical safe drug use. Methods In line with the Technical Guidelines for Long-term Toxicity Studies of Traditional Chinese Medicine and Natural Medicines, 80 normal rats were randomly divided into the normal group, and Qing'e pill L、M、H groups (the doses were 4.82, 11.25 and 22.50 g/kg respectively),with 20 rats in each group. After 90 days of continuous administration, the condition of rats in each group was observed. The body weight, daily diet and daily water intake of rats were recorded every 9 days. After the last administration, 10 rats were randomly chosen from each group for blood routine test and blood biochemical index test. Such viscera as the heart, liver, spleen, lung, kidney, adrenal gland, thymus, uterus, ovary, brain, stomach, thymus and epididymis were weighed to calculate the visceral brain coefficient. Histopathological examination was performed. The rest of the rats entered the recovery period, and the same detection was conducted as in the administration period. Results After 90 days of consecutive administration, there was no significant difference in body weight, daily diet and daily water intake between the administration groups and the normal group (P<0.05). The blood biochemical indexes of rats in each group increased or decreased to different extents. Liver cells in Qing'e pill H group showed punctate necrosis. Conclusion The 90 days of continuous administration of Qing'e pills to rats 22.50g/kg (equivalent to 70 times the clinical daily dosage of 70 kg) can cause liver injury in rats, so Qing'e pills should be administered according to the doctor’s instructions, and those with liver and kidney dysfunction should use these pills with caution.

Key words: Qing'e pills, liver injury, compatibility, chronic toxicity, rats