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首页> 外文期刊>European journal of pharmaceutical sciences >In vivo pharmacokinetics in human volunteers: oral administered guar gum-based colon-targeted 5-fluorouracil tablets.
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In vivo pharmacokinetics in human volunteers: oral administered guar gum-based colon-targeted 5-fluorouracil tablets.

机译：人类志愿者的体内药代动力学：口服基于瓜尔豆胶的结肠靶向5-氟尿嘧啶片。

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摘要

The objective of the present study is to compare the guar gum-based colon-targeted tablets of 5-fluorouracil against an immediate release tablet by in vitro dissolution and in vivo pharmacokinetic studies in human volunteers. Twelve healthy volunteers participated in the study. 5-Fluorouracil was administered at a dose of 50 mg both in immediate release tablet and colon-targeted tablet. On oral administration of colon-targeted tablets, 5-fluorouracil started appearing in the plasma at 6 h, and reached the peak concentration (C(max) of 216+/-15 ng/ml) at 7.6+/-0.1 h (T(max)), whereas the immediate release tablets produced peak plasma concentration (C(max) of 278+/-21 ng/ml) at 0.6+/-0.01 h (T(max)). The AUC(0- infinity ) for 5-fluorouracil from colon-targeted tablet and immediate release tablet were found to be 617+/-39 and 205+/-21 ng/ml/h, respectively. Colon-targeted tablets showed delayed t(max), delayed absorption time (t(a)), decreased C(max) and decreased absorption rate constant when compared tothe immediate release tablets.The results of the study indicated that the guar gum-based colon-targeted formulation did not release the drug in stomach and small intestine, but delivered it to the colon resulting in a slow absorption of the drug and making it available for local action in colon.
机译：本研究的目的是通过在人类志愿者体内进行体外溶出和体内药代动力学研究，比较瓜尔胶基于瓜尔胶的结肠靶向5-氟尿嘧啶片与速释片。 12名健康志愿者参加了研究。 5-氟尿嘧啶以速释片剂和结肠靶向片剂的50 mg剂量给药。口服结肠靶向片剂后，6-氟尿嘧啶在6 h开始出现在血浆中，并在7.6 +/- 0.1 h（T（T）达到峰值浓度（C（max）为216 +/- 15 ng / ml）） （max）），而速释片在0.6 +/- 0.01 h（T（max））时产生峰值血浆浓度（C（max）为278 +/- 21 ng / ml）。发现来自结肠靶向片剂和即释片剂的5-氟尿嘧啶的AUC（0-无穷大）分别为617 +/- 39和205 +/- 21 ng / ml / h。与即释片剂相比，靶向结肠的片剂显示出t（max）延迟，吸收时间（t（a））延迟，C（max）降低和吸收速率常数降低。研究结果表明，基于瓜耳胶的片剂结肠靶向制剂不会在胃和小肠中释放药物，而是将其递送至结肠，导致药物吸收缓慢，使其可在结肠中局部使用。

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