健康志愿者单次口服壮骨胶囊的安全性及耐受性研究

目的评价健康志愿者口服壮骨胶囊的安全性和耐受性.方法 34名年龄19～26岁的健康志愿者,男女各半,筛选合格后根据性别和体重随机分为600、1 200、1 800、2 400及3 000 mg 5个剂量组(每组4～8人),由最小剂量组开始,逐组进行试验.观察指标有临床症状、生命体征、心电图、血常规、尿常规、血生化、凝血功能、性激素等.结果给药后各组志愿者的生命体征、心电图、血常规、尿常规、凝血功能未发现有临床意义的异常变化.结论单次口服壮骨胶囊的剂量在3 000 mg内安全,志愿者耐受性良好.

Study on safety and tolerance of single oral dose of Zhuanggu Capsules in healthy volunteers

Objective To evaluate the safety and tolerance of Zhuanggu Capsules in healthy volunteers.Methods 34 healthy volunteers aged 19 to 26 and evenly composed of male and female were randomly divided into five dose groups including 600 mg,1 200 mg,1 800 mg,2 400 mg and 3 000 mg,there were 4~8 healthy volunteers in each group.The study started from the lowest dose group.The clinical symptoms,vital signs,electrocardiogram,routine blood test,routine urine test,blood biochemical tests,coagulation function and sex hormone were recorded and evaluated.Results No adverse reactions were observed in volunteers.Conclusion Single oral dose of Zhuanggu Capsules at 3 000 mg or less was safe and well tolerated.