两种糖浆剂中盐酸伪麻黄碱的药代动力学和相对生物利用度

 目的:研究盐酸伪麻黄碱在正常人体内的药代动力学,并对其生物利用度进行评价?方法:8名健康志愿者随机交叉po百服咛儿童感冒咳嗽糖浆和进口泰诺儿童感冒咳嗽糖浆各30ml(含盐酸伪麻黄碱90mg)?采用HPLC测定血清中的血药浓度?结果:血清中药物浓度分别在(1.09±0.6)h和(1.71±1.06)h达到峰值(359±80.93)ng·ml^-1和(364.05±94.09)ng·ml^-1?两种制剂的消除半衰期分别为(4.48±0.83)h和(3.81±0.96)h,血药浓度曲线下面积分别为(2689.31±427.62)ng·h·ml^-1和(2661.86±302.86)ng·h·ml^-1?药-时曲线符合一级吸收的单室模型;其相对生物利用度为(100.93±11.08)%?结论:经统计学分析,两种制剂的盐酸伪麻黄碱在人体内的药动学性质相似,两者具有生物等效性?

Pharmacokinetics and relative bioavailability of Pseudoephedrine

BJECTIVE: To study the pharmacokinetics of pseudoephedrine in normal volunteers and to assess its bioequivalence. METHOD: The pharmacokinetics of pseudoephedrine was determined following a single oral dose of 90mg to 8 volunteers in an open randomized crossover study.Drug concentrations in serum were assayed by HPLC. RESULTS: The peak levels in serum averaged (35980.93)ngml-1 and (364.0594.09)ngml-1 at (1.090.6)h and (1.711.06)h,the terminal elimination half lives were (4.480.83)h and (3.810.96)h for BUFFERIN and TYLENOL,respectively,The areas under the drug concentrationtime curves were (2689.31427.62)nghml-1 and (2661.86302.86)nghml-1 respectively for the two formulations.The concentrationtime curves after medication conformed to a 1compartment open model with first order absorption. CONCLUSION: The pharmacokinetics of the two formulations of pseudoephedrine was similar and the resesult of statistical analysis showed that the two formulations were bioequivalent.