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目的:了解国产奥沙普秦肠溶胶囊在人体的药物动力学及相对生物利用度。方法:采用随机交叉试验设计,10例男性健康者单剂量口服奥沙普秦肠溶胶囊与片剂 600 mg,以 HPLC法测定血药浓度。结果:胶囊与片剂各项动力学参数为:(1)AUQO ——(7572±s 695) mg· L-1与(8201± 949)mg.L-1.h-1;(2)T 1/2-(59±7) h与(53±4 ) h ,上述2参数经t检验;差别无统计学意义(P>0. 05);(3) Cmax--(83± 15)mg.L-1与(126± 21)mg·L-1;(4) Tmax-(15± 7) h与(4± 3) h,经方差分析,均 P< 0. 05,符合肠溶制剂原有性质。胶囊的相对生物利用度为(93± 13)%,经双向单侧 t检验作统计学分析,(P>0.05)。结论:胶囊与片剂两者之间具有生物等效性。
Objective: To understand the pharmacokinetics and relative bioavailability of domestic oxaprozen enteric-coated capsules in human. Methods: A randomized crossover trial was designed. One hundred doses of oxaliputan enteric-coated capsules and tablets were administered to 10 healthy male volunteers. Plasma concentrations were determined by HPLC. Results: The kinetic parameters of capsules and tablets were as follows: (1) AUQO - (7572 ± s 695) mg · L -1 and (8201 ± 949) mg respectively. L-1. h-1; (2) T 1 / 2- (59 ± 7) h and (53 ± 4) h, the two parameters were tested by t test; the difference was not statistically significant (P> 0.05) - (83 ± 15) mg. L-1 and (126 ± 21) mg · L-1; (4) Tmax- (15 ± 7) h and (4 ± 3) h, respectively. 05, in line with the original nature of enteric preparations. The relative bioavailability of capsules was (93 ± 13)%, and was analyzed by bi-directional unilateral t-test (P> 0.05). Conclusion: Bioequivalence between capsules and tablets.