OBJECTIVE: To study the acute and chronic toxicity of Yinning tablets, and to evaluate its safety. METHODS: 40 healthy KM mice were randomly divided into 2 groups, including blank control group (constant volume normal saline) and Yining tablet group (32 g·kg‐1). Mice were given relevant drugs intragastrically every 6 h in 24 h in Yining tablet group, and the general symptom, death, weight and food intake of mice were observed. Mice were sacrificed 14 days later, and organs were observed by eyes, and MTD was counted. 48 healthy SD rats were randomly divided into 4 groups, including blank control group, Yining tablet high-dose, medium-dose and low-dose groups (6.0,3.0,0.6 g·kg‐1). They were given drug intragastrically once a day for 30 days. Those rats were sacrificed at 24 h after last administration. Hematology and blood biochemistry index were determined after collecting blood sample from abdominal aorta, and the general symptom, death, weight and food intake of rats were observed and the organs coefficients were calculated and pathological section was developed. The pathological changes of major organs were investigated. RESULTS: The detected indexes of acute toxicity test of all mice in Yinning tablet group were in normal range,the MTD of acute toxicity test was 32 g·kg ‐1. The detected indexes of chronic toxicity test of all rats in Yining tablet groups were in normal range. There were not significant differences in structure of organs. CONCLUSION: Yinning tablets show low toxicity. It provides theoretic basis for the use of Yinning tablets in the clinic.%目的:研究因宁片的急性和慢性毒性作用,评价其安全性.方法:40只昆明种小鼠随机分为空白对照(等容生理盐水)和因宁片(32 g·kg-1)组.因宁片组24 h内连续2次(间隔6h)灌胃给药后观察小鼠的一般状况、死亡情况、记录体重和摄食量,14d后处死并作大体解剖,肉眼观察各脏器变化,计算最大耐受量(MTD). 48只SD大鼠随机分为空白对照(等容生理盐水)与因宁片高、中、低剂量(6.0、3.0、0.6 g·kg-1)组.灌胃给药,每天1次,连续30 d,末次给药24 h后处死大鼠,腹主动脉取血测定各项血液学指标和血液生化指标,记录各脏器重量、体重、摄食量,计算脏器系数,并作病理切片,观察组织形态学的变化.结果:急性毒性实验中因宁片组各项指标正常,MTD为32 g·kg-1；慢性毒性实验中因宁片高、中、低剂量组大鼠一般状况正常,各组中未见多指标同时明显异常,组织结构未见明显异常.结论:因宁片毒性低,可为临床安全用药提供理论依据.
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