Abstract:

In order to study clinical safety of Shegan Dilong particles, the safety pharmacology study was carried out for the first time by non-invasive way. Three doses of Shegan Dilong particles including high dose (2.0 g·kg^－1), medium dose (1.0 g·kg^－1) and low dose (0.5 g·kg^－1, which is equivalent to the recommended dose) were given to the anesthetized dogs, and there was also a group of anesthetized dogs given saline. Then the mean arterial pressure, heart rate, body temperature, standard Ⅱ lead ECG, respiratory rate, tidal volume, oxygen saturation, respiration curve, urine of eleven indicators, urine weight gain and other related indicators of the anesthetized dogs were observed. Meanwhile Kunming strain mice were given the particles in accordance with the above different doses, and the spontaneous activities of mice were observed. The above indicators observed were used to illustrate the impact of the particles on the cardiovascular system, respiratory system, urinary system and central nervous system. The results showed that Shegan Dilong particles given by oral according to the dose of 2.0 g·kg^－1 had no significant effect on the cardiovascular system, respiratory system and urinary system of anesthetized dogs. The results of the mice’s spontaneous activities also showed that the total distance, the side of distance, the angle of distance and time among the groups had no significant differences (P>0.05). And the general conduct of activities, posture and gait of the mice performed normal, while muscle trembling, anxiety, running, screams and other abnormalities in mice didn’t exit. It indicated that in the range of the test doses, the particles had no effect on the central nervous system in mice. The results suggested that at least in the range of 0.5-2.0 g·kg^－1 the Shegan Dilong particles had no significant effect on animal cardiovascular system, respiratory system, urinary system and central nervous system, and it also suggested that the adverse reactions was small. So it’s a safe drug suitable for the clinical application.