摘要
目的研究注射用奥曲肽在正常人体内的药物动力学行为,评价其两种制剂的生物等效性。方法人体试验采用双交叉设计,18名健康志愿受试者交叉sc奥曲肽供试制剂与参比制剂。采用HPLC-MS法测定奥曲肽血药浓度。用3p97药动学程序处理试验数据,并对试验结果进行方差分析和双单侧t检验。结果奥曲肽的相对生物利用度为101.01%±16.00%。两种制剂奥曲肽的AUC0→T分别为48.31±15.85、48.75±17.15ng.h.ml-1;Tmax分别为0.487±0.134、0.469±0.140h;Cmax分别是21.86±9.12、21.45±9.81ng.ml-1。结论对sc两种制剂后的lnAUC0→∞l、nAUC0→tl、nCmax经双单侧t检验,Tmax经秩和检验进行生物等效性评价,表明两者为生物等效制剂。
OBJECTIVE To investigate the pharmacokineties and bioequivalence of Octreotide injection in healthy volunteers. METHODS A randomized crossover design was performed in 18 healthy male volunteers. In the two study periods, a single 200 μg dose of either test or reference preparation was administered to each volunteer. Octreotide concentration in plasma was detected by HPLC - MS. The experiment data was calculated with 3p97 program. The results were analyzed by ANOVA and two one - side test. RESULTS The relative bioavailability of oc- treotide in the test was 101.01%±16.00 % ; AUC0→T of octreotide of test and reference preparations were 48.31± 15.85 ng. h. ml^-1 and 48.75 ± 17.15ng.h. ml^-1, respectively; Tmax were 0.487± 0.134 h and 0.469 ±0. 140 h, respectively; Cmax were 21.86± 9.12 ng. ml^-1 and 21.45 ± 9.81 ng. ml^- 1, respectively. CONCLUSION Bioequivalent evaluation of two preparations by analyzing with two one - sided test and rank sum test show that the two preparations are bioequivalent.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2005年第5期414-416,共3页
West China Journal of Pharmaceutical Sciences
