Evaluation of acute and long-term toxicity of Naoshuning capsule in mice

  Background  Naoshuning capsule is an experienced prescription for the treatment of cerebral apoplexy developed by Zhang Meikui, a chief physician of Chinese PLA General Hospital, after years of clinical research. It has definite clinical efficacy and less side effects, and is suitable for the acute and congruent stage of ischemic stroke. The research of production technology and quality control system has been completed in the early stage.

  Objective   To investigate the characteristics of the acute toxicity and long-term toxicity of Naoxuning capsule, and provide evidences for its clinical safety.

  Methods  In the acute toxicity experiment, 40 Kunming mice were randomly divided into two groups (sex in half) and given the maximum dose of 18g/kg once by gavage. The body weight, general state and appearance of main organs of the animals within 14 days after the administration were observed, and the poisoning manifestations and death of the mice were recorded. In the long-term toxicity test, 120 SD rats were randomly divided into low (1.8 g/kg), medium (3.6 g/kg), high (7.2 g/kg) dose group, and normal saline group (sex in half). The drug was administered continuously for 13 weeks, and body quality and food intake were tested and recorded once a week. Hematology, blood biochemistry, relative quality of viscera and histopathology were tested at 24 hours after drug withdrawal and 4 weeks after convalescence.

  Results   Acute toxicity test showed that no death or obvious poisoning symptoms were observed in the mice during the 14-day observation period, and there was no significant difference in body weight between the control group and the administration group (P＞0.05). Long-term toxicity experiments showed that compared with the control group, there were no statistically significant differences in body weight and organ index (P＞0.05) among the high, medium and low dose groups, and both hematological and blood biochemical indexes were within the normal detection reference range of references. No pathomorphological changes of viscera caused by drug poisoning were observed in each dose group.

  Conclusion  Naoshuning capsule shows no obvious toxic reaction in mice or rats.