红珠胶囊在健康人体的耐受性

Tolerance of Hongzhu capsule in healthy volunteers

目的观察红珠胶囊(止咳药)单次及连续给药对健康人体的耐受性。方法将40名健康志愿者分为240、480、720、960、1260、1680mg单次给药组和1260、1680mg连续给药组。观察指标为一般情况、生命体征及实验室检查等。结果单次和连续给药,各组用药前后及各监测时点生命指征均未见异常;在各项检验指标中,有3例异常但未经治疗均恢复正常;其余均在临床正常范围内。结论健康志愿者对红珠胶囊单次(240～1680mg)及连续(1260～1680mg)给药均有较好的耐受性,最大给药剂量为1680mg。

Objective To observation the tolerance of single - close and multiple - close intravenous drip of Hongzhu capsule in Chinese healthy volunteers. Methods Forty healthy volunteers were randomized into 6 singleclose groups （240, 480, 720,960, 1260 and 1 680 mg respectively） and 2 multiple - close groups （ 1 260,1 680 rag）. Indicators such as general, vital signs and laboratory tests were observed. Results In the single -close and multiple groups, there were no abnormal findings in the vital signs before and after the administration at every monitoring time point. The test indicators all within clinical normal range except 3 volunteers which have returned to normal rang without treatment. Conclusion The range of 240 ～ 1680 mg in single dose and 1260 ～ 1680 mg in multiple dose Hongzhu capsule were well tolerated in healthy volunteers.