中国临床药理学杂志2012，Vol.28Issue(9)：653-655,3.
人参次苷H滴丸Ⅰ期人体耐受性研究
Tolerance study of Ginsenoside H drop pill in Chinese health volunteers
赵敏 1聂朝宏 2苗佳 2张瑞明3
作者信息
- 1. 天津中医药大学中药学院,天津300193
- 2. 天津天士力集团研究院临床医学部,天津300410
- 3. 四川大学华西医院国家药物临床研究机构GCP中心,成都610041
- 折叠
摘要
Abstract
Objective To observe the safety and tolerance of single and multi - doses Gensenoside H drop pill.Methods The study was de-signed as a single center, open - label, randomized, uncontrolled trial, which conducted the single - and multi - dose administration groups ac-cording to schema of dose - escalation. There were 38 volunteers assigned to 7 groups in single -dose study, and 18 volunteers assigned to 3 groups in multi - dose study. Physical examination and laboratory test were per-formed. Adverse drugs reaction (ADR) were recorded.Results All 56 subjects completed the study. There were 5 ADR cases in single - dose study, including mouth ulcer, palpitation and abdominal discomfort. All of the subjects in multi -dose study had ADR, including dryness of eye and mouth and so on. These ADR were mild and transient without dose corre-lation. Conclusion Gensenoside H drop pill administered up to 54 pill or 15 pill twice a day for 14 days are safe and tolerable.关键词
最大耐受剂量/人参次苷H滴丸/人参皂苷Rh2Key words
multi - doses/ Ginsenoside H drop pill/ ginsenoside - Rh2分类
医药卫生引用本文复制引用
赵敏,聂朝宏,苗佳,张瑞明..人参次苷H滴丸Ⅰ期人体耐受性研究[J].中国临床药理学杂志,2012,28(9):653-655,3.
