ABSTRACT
This study was aimed to observe the acute toxicity and long-term toxicity of Meng-Gen-Wu-Su-18 (MGWS-18) Pills, in order to provide references for safety application of this medicine in the clinical practice. MGWS-18 Pills suspension was intragastric administered to mice twice (0.2 mL/10 g) in 6 hours with maximal con-centration (0.4 g·mL-1). And the acute toxicity reaction was observed for 14 days. The dose of maximum, middle and minimum (3.67 g·kg-1, 1.84 g·kg-1, 0.92 g·kg-1) of MGWS-18 Pills were intragastric administered continuously to rats once a day for 180 days. The rats were observed 60 days after drug withdrawal. The results showed that the maximal tolerated dose (MTD) of MGWS-18 Pills was bigger than the dose of 16 g·kg-1 (which was equivalent to 436.36 times in clinical doses). There were significant differences on ALB, UREA, AST, TBIL, and CHOL between the control group and the maximum dose group of MGWS-18 Pills (P<0.05, or P<0.01) after 180 days of medica-tion. There were significant differences on ALB and UREA between the control group and the middle dose group (P< 0.05). There was no significant difference between the control group and the minimum dose group. Protein cast and degeneration necrosis at different levels of the epithelial cells of the proximal tubules were appeared in the maximum dose group after medication for 180 days. After 60 days of drug withdrawal, there were no significant dif-ferences on the general condition, body weight, hematological indexes, serum biochemical indexes, organ coefficient and etc. between the control group and each animal group. There was recovery tendency on the kidney damage of the maximum dose group. It was concluded that the basic safety intragastric administration dosage of MGWS-18 Pills in rats was 0.92 g·kg-1 (which was equivalent to 25 times in clinical doses).