摘要
目的 研究两种尼扎替丁胶囊的人体相对生物利用度。方法 采用高效液相色谱紫外检测法测定20名健康受试者单剂量po 300 mg尼扎替丁国产或进口胶囊剂后的药动学数据。结果 po国产与进口制剂后AUC0-12均值分别为(6.66±1.54)和(6.79±1.56)μg·h·mL-1,实测cmax均值分别为(2.10±0.64)和(2.06±0.74)μg·mL-1,实测tmax均值分别为(1.32±0.59)和(1.67±1.04)h,国产尼扎替丁胶囊的相对生物利用度为(98.40±10.50)％。结论 经统计学分析,两种制剂具有生物等效性。
OBJECTIVE: To study the relative bioavailability of two nizatidine capsules in human. METHODS: A single oral dose of 300 mg domestic or imported capsules were administered to 20 healthy volunteers in a randomized crossover study. RESULTS: The pharmacokinetic parameters included: AUC0-12(6.66 ± 1.54) and (6.79 ± 1.56) μg middot; h·mL-1, Cmax (2.10 ± 0.64) and (2.06 ± 0.74) μg-mL -1, tmax(1.32 ± 0.59) and (1.67 ± 1.04) h, respectively. The relative bioavailability of domestic capsules to imported capsules was (98.40 ± 10.50) %. CONCLUSION: The two kinds of capsules were bioequivalent.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2004年第11期852-854,共3页
Chinese Pharmaceutical Journal
关键词
尼扎替丁
高效液相色谱法
药动学
生物等效性
Biomedical engineering
Drug therapy
Patient monitoring
Pharmacokinetics
