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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。
Objective To observe the acute toxicity and long-term toxicity of Yigu oral liquid. Methods Acute toxicity test: 40 ICR mice were randomly divided into control group and treatment group. The maximum tolerated dose of oral Osthole Mice was determined by the maximum dose method. Long-term toxicity test: 80 SD rats were randomly divided into 4 groups. The rats were orally administrated in high, medium and low doses (80, 40, 20 g.kg 1) once daily for 12 weeks. The general situation of rats, blood tests and blood biochemistry, histopathological changes and 28 d after discontinuation of the above indicators. Results The maximum tolerated dose of Oral Oral Liquid in mice is 358.852 g.kg -1, which is equivalent to 287.08 times of the daily dose of clinical adult. After 90 days of continuous administration, the levels of alkaline phosphatase and albumin in the high-dose group were lower than those in the blank control group (P <0.05). After 28 days of withdrawal, body weight, food intake, behavioral activity, Coefficients were normal, pathological examination, each group of organs did not find any significant change. Conclusion Under this test condition, the oral solution is safe and nontoxic.