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目的:对吲哚美辛(IDM)肠溶滴丸的药动学进行考察。方法:以比格犬为实验动物,以市售IDM肠溶片为对照,对同剂量IDM肠溶滴丸单剂量给药的药动学进行研究,用SPSS 21.0软件进行模型拟合及参数计算,并进行生物等效性评价。结果:IDM肠溶滴丸及肠溶片均符合一室模型,C_(max)、T_(max)、AUC_(0-∞)、Tlag等差异均有统计学意义(P<0.05),C_(max)及AUC_(0~∞)均显著升高,T_(max)及Tlag均显著缩短,肠溶滴丸的相对生物利用度为(121.0±7.7)%。结论:IDM肠溶滴丸相对于肠溶片而言,吸收显著增加,起效明显加快,值得进一步研发。
Objective: To investigate the pharmacokinetics of indomethacin (IDM) enteric drops. Methods: Beagle dogs were used as experimental animals, and the commercially available IDM enteric-coated tablets were taken as control. The pharmacokinetics of single-dose IDM enteric-dripping pills was studied. The model fitting and parameter calculation were performed by SPSS 21.0 software , And bioequivalence assessment. Results: The IDM enteric pills and enteric-coated tablets were in accordance with the one-compartment model. The differences of C max, T max, AUC 0 -∞ and Tlag were statistically significant (P <0.05) max and AUC 0 ~ ∞ were significantly increased, T max and Tlag were significantly shortened, and the relative bioavailability of enteric-coated dripping pills was (121.0 ± 7.7)%. Conclusion: Compared with enteric coated tablets, the absorption of IDM enteric drip pills significantly increased and the onset of effect obviously accelerated, worth further research and development.