摘要
目的:制备阿司匹林咀嚼片,评价咀嚼片与普通口服片的生物等效性。方法:采用直接压片法制备阿司匹林咀嚼片,高效液相色谱法测18例男性健康志愿者交叉服用咀嚼片和普通口服片后的血药浓度,数据经3P97软件处理,以方差分析和单双侧检验评价各参数的生物等效性。结果:咀嚼片的药动学参数为:AUC=(163.90±77.06)μg·h·mL-1,Cmax=(28.58±6.71)μg·mL-1,Tmax=(0.79±0.20)h;普通口服片的药动学参数为:AUC=(154.41±74.41)μg·h·mL-1,Cmax=(27.28±6.94)μg·mL-1,Tmax=(0.83±0.23)h,相对生物利用度为(101.09±13.56)%。结论:阿司匹林咀嚼片和普通口服片具有生物等效性。
Objective:To prepare aspirin chewable tablets and estimate its bioequivalence. Methods: Aspirin chewable tablets were prepared by press technique and its bioequivalence was estimated in 18 healthy male volunteers by cross-over method using aspirin tablet as control. The serum concentration of aspirin was determined by HPLC method. Results:The pharmacokinetic parameters of chewable tablets AUC=(163.90±77.06)μg·h·mL-1,Cmax=(28.58±6.71)μg·mL-1,Tmax=(0.79±0.20) h and of aspirin tablets AUC = (154.41±74. 41)μg·h·mL-1 Cmax= (27.28 ?6. 94)μg·mL-1, Tmax= (0. 83±0. 23)h. The relative bioavailability for chewable tablets was (101. 09 ± 13. 56)% . Conclusion: Aspirin chewable tablet were bio-equivalent with aspirin tablets.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2004年第1期42-44,共3页
Chinese Journal of New Drugs