静脉留置针用于麻醉新药Ⅰ期临床药代动力学研究的可行性  

Application of Indwelling Needle in Phase Ⅰ Clinical Pharmacokinetics of Anesthetic New Drug

作　　者：廖天治[1] 刘帆[1] 向璇 陈弟洪[1] 张文胜[2] 

机构地区：[1]四川大学华西医院,四川成都610041 [2]四川省骨科医院,四川成都610041

出　　处：《中国药业》2014年第21期90-91,共2页China Pharmaceuticals

摘　　要：目的探讨留置针在麻醉新药Ⅰ期临床药代动力学试验中采集成年健康受试者静脉血标本的可行性。方法对30例健康受试者,随机分为10,20,30 mg/kg 3个剂量组,在单次静脉给药前后以留置针采集血样标本,法斯特秒表计时,根据采血量计算采血速率。结果按照试验设计,顺利完成30例健康受试者共660次血样采集。结论留置针采血,可以满足麻醉新药临床药代动力学试验定时定量大量血标本采集的要求。Objective To explore the feasibility of indwelling needle for collecting venous blood specimens from adult healthy volunteers in the phase Ⅰ clinical pharmacokinetics trials of anesthetic new drugs. Methods 30 healthy subjects were randomly divided into10 mg / kg,20 mg / kg,30 mg / kg dose groups. The indwelling needle was adopted to collect venous blood specimens before and after single intravenous administration with Fast stopwatch for timing. The collecting blood speed was calculated by the amount collecting blood sample. Results According to the experimental design,660 times of blood sample collection in 30 healthy subjects were smoothly completed. Conclusion The indwelling needle for blood sampling can meet the requirement of timing, quantitative and a large number of blood sample collection in clinical pharmacokinetic trials of anesthetic drugs.

关 键 词：静脉留置针 麻醉新药 临床Ⅰ期药代动力学试验 采集血样 

分 类 号：R965.2[医药卫生—药理学] R969.1[医药卫生—药学]