红珠胶囊在健康人体的耐受性  

Tolerance of Hongzhu capsule in healthy volunteers

作　　者：王文萍[1] 吴萍[1] 李晓[1] 韩可丽[1] 赵友林[1] 袁春平[2] 苏薇薇[3] 

机构地区：[1]辽宁中医药大学附属医院Ⅰ期临床研究室,沈阳110032 [2]广东环球制药有限公司,广东顺德528303 [3]中山大学生命科学学院,广州510275

出　　处：《中国临床药理学杂志》2008年第1期21-24,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：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.

关 键 词：红珠胶囊 耐受性 

分 类 号：R562[医药卫生—呼吸系统] R974.2[医药卫生—内科学]