目的 選擇健康志愿者口服不同劑量的冬青通脈膠囊，考察人體的耐受性和安全性，并為Ⅱ期臨床試驗提供安全的劑量范圍。方法 將篩選合格的44名健康受試者，按從低到高的順序口服一個劑量的試藥，而后進(jìn)行連續(xù)給藥耐受性試驗。結(jié)果 單次給藥組受試者出現(xiàn)肌酐、血尿素氮輕度升高，尿蛋白陽性等與藥物有關(guān)的實驗室指標(biāo)異常。連續(xù)給藥組未發(fā)現(xiàn)與藥物有關(guān)的實驗室指標(biāo)異常。結(jié)論 總體來說，當(dāng)一次用藥不超過3粒（0.75 g），或連續(xù)給藥不超過每次2粒、每天3次（1.5 g），在人體應(yīng)用冬青通脈膠囊是安全的。

Objective In order to observe the tolerance and safety of human body, healthy volunteers were selected to take orally Dongqing Tongmai Capsula at different doses, and the safe dosage range in phase Ⅱ clinical trials were provided. Methods 44 healthy volunteers took orally the drug of one of 4 different dosages increasing by degree, and then continous-dose tolerance test was carried out. Results Abnormal laboratory indicators associated with the tested drug, such as slight increment of creatinine, urea nitrogen, and positive urine protein appeared in single-dose group, while abnormal indicator was not detected in continous-dose group. Conclusion Overall, single-dose less than 3 pills (as much as 0.75 g) or continous-dose less than 2 pills Tid (as much as 1.5 g) Dongqing Tongmai Capsula could be safe for human body.