摘要
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。
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.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1999年第7期472-474,共3页
Chinese Pharmaceutical Journal
