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机构地区:[1]宜春学院化学与生物工程学院,江西宜春336000 [2]金华康恩贝生物制药有限公司,浙江金华321016 [3]沈阳药科大学药学院,辽宁沈阳110016
出 处:《中国医院药学杂志》2008年第12期984-986,共3页Chinese Journal of Hospital Pharmacy
摘 要:目的:对盐酸伊托必利缓释片和分散片在家犬体内进行药动学研究。方法:6只家犬按照单剂量双周期实验设计方案给药,建立一个测定狗血中的伊托必利的高效液相色谱法。结果:2种制剂在体内均符合单隔室一级吸收模型,缓释片和分散片Cmax分别为(548.6±54.2)μg·L-1和(798.1±42.5)μg·L-1,tmax分别为(6.7±1.2)h和(1.83±0.25)h,应用3P97药动学程序进行计算,t1/2(Ke)分别为(6.0±0.6)h和(5.72±0.26)h,AUC0-∞分别为(6.6±0.5)mg·L-1·h和(7.0±0.6)mg·L-1·h。结论:盐酸伊托必利缓释片具有显著缓释作用。OBJECTIVE The pharmacokinetics was studied on sustained-release tablets of itopride hydrochloride using health dogs and was compared with the dispersible tablets of itopride hydroehloride. METHODS A single dose of the sustained-release dispersible tablets of itopride hydrochloride were given separately to six dogs according to the double-periodical crossed design. An HPLC method was established for the determination of the plasma concentration of itopride hydrochloride. RESULTS After oral administration, the pharmacokinetics parameters of sustained-release tablets Cmax tmax, t1/2(Ke), AUC0→∞ were (548. 6 ± 54. 2) μg·L^-1 , (6. 7 + 1.2)h, (6. 0± 0. 6)h and (6. 6± 0. 5)mg·L^-1·h respectively, and the corresponding parameters of dispersible tablets were(798.1± 42.5)μg·L^-1 , (1.83 ±0. 25)h, (5. 72 ± 0. 26)h and (7.0± 0. 6)mg·L^-1·h CONCLUSION The sustained-release tablets of itopride hydrochloride have an significant sustained-released effect.
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