益骨口服液的毒理学研究

Study on Toxicity of Yigu Oral Solution

关键词:  益骨口服液  急性毒性  长期毒性

Key words:  Yigu oral solution  acute toxicity  chronic toxicity

摘要:

目的 观察益骨口服液的急性毒性和长期毒性。方法 急性毒性试验：ICR小鼠40只，随机分成对照组和给药组，采用最大给药量法测定小鼠口服益骨口服液最大耐受量。长期毒性试验：SD大鼠80只，随机分成4组，采用高、中、低3个剂量(80，40，20 g·kg^-1)灌胃给药，每天1次，连续12周，观察大鼠的一般情况，检测血常规及血液生化学、组织病理变化及停药28 d后上述指标的变化。结果 小鼠口服益骨口服液的最大耐受量为生药量358.852 g·kg^-1，此剂量相当于临床成人拟日服剂量的287.08倍。连续给药90 d时，高剂量组的碱性磷酸酶和白蛋白低于空白对照组(P<0.05)；停药28 d后，大鼠体重、摄食量、行为活动、血象、重要器官脏器系数均正常，病理学检查，各组各脏器均未发现明显的改变。结论 在本次试验条件下，该口服液安全无毒。

Abstract:

OBJECTIVE To observe the acute and chronic toxicity of Yigu oral solution. METHODS Tests of acute toxicity: 40 ICR mice were randomly divided into two groups, the control group and the drug test group. The maximum tolerable dosage (MTD) of Yigu oral solution were determined by i.g. administration in mice. Tests of chronic toxicity: 80 SD rats were randomly divided into four groups: high, middle, and low dose(80, 40, 20 g·kg^-1) of Yigu oral solution group as well as the control group. Yigu oral solution was continuously administered intragastrically for 12 weeks, once per day. The growth condition, blood routine test, blood biochemical indexes and histopathological changes of rats were measured immediately at the terminal of experiment and 28 days after the terminal of experiment. RESULTS The MTD of Yigu oral solution via i.g. administration was 358.852 g·kg^-1 in mice. It was equivalent to 287.08 times of the dosage used in clinic. After rats were administered consecutively for 12 weeks, the level of ALP and ALB in high dose group were lower than the control goup (P<0.05). Twenty-eight days after the terminal of experiment, the body weight of rats, food consumption, behavioral activity, hematological parameters as well as viscera index of important organs were normal. No obvious histopathologic changes of important organs were found. CONCLUSION Under this experimental condition, Yigu oral solution is safe and nontoxicity.