关键词: 痰热清注射液, 安全药理学, Beagle犬, 小鼠

Abstract: Objective To observe the effects of Tanreqing injection on the cardiovascular and respiratory systems in Beagle dogs and the central nervous system in ICR mice, and to provide the animal safety data for its clinical application. Methods A total of 24 Beagle dogs (12 males and 12 females) were randomly divided into low dose (2.5 mL stock solution/kg), medium dose (5 mL stock solution/kg), high dose (10 mL stock solution/kg) Tanreqing injection groups and a solvent control group according to their body weight; there were 6 dogs in each group with intravenous injection at the right cephalic vein of forelimb under anesthesia. Then the blood pressure, heart rate, electrocardiogram and respiration rate were measured before, during at 40 and 80 min, as well as 5, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 min after administration of Tanreqing injection. A total of 160 ICR mice (half male and female) were selected, and 60 of them were randomly divided into low dose (3.6 mL stock solution/kg), medium dose (6.25 mL stock solution/kg), high dose (12.5 mL stock solution/kg) Tanreqing injection groups, a solvent control and a positive control groups according to their weight, and their general behavior and spontaneous activity were recorded after different doses of Tanreqing injection via the tail vein. The coordinated movement of other 50 mice with the same grouping method were measured at different time points after administration of Tanreqing injection. The synergistic effect of pentobarbital sodium hypnosis at subliminal dosage was tested in the rest of 50 mice with the same grouping method. Results Compared with the solvent control group at the same time point or the group itself before administration, there were no significant differences in systolic pressure, mean arterial pressure, electrocardiogram and respiration rate (all P>0.05) of the Beagle dogs in the Tanreqing injection groups at different doses; while the diastolic pressure and heart rate at some time points were statistically significant (P<0.05 or P<0.01), but there was no dose or time dependent effect. The spontaneous activity of the ICR mice was decreased at each time point (P<0.05, P<0.01 or P<0.001), and the oordinated movement grades were increased at 30, 50 and 90 min after high-dose Tanreqing administration (P<0.05, P<0.01 or P<0.001). Conclusion No significant effects of Tanreqing injection on the cardiovascular and respiratory systems of Beagle dogs are found after single intravenous injection in this experiment. High-dose Tanreqing injection has certain effects on the central nervous system of mice, mainly reduced spontaneous activity and in coordinated movement, which may be related to bear bile powder, the main active ingredient of Tanreqing injection.

Key words: Tanreqing injection, Safety pharmecology, Beagle dogs, Mice