罗红霉素胶囊在人体的药代动力学及生物等效性.docVIP

罗红霉素胶囊在人体的药代动力学及生物等效性 目录 TOC \o 1-9 \h \z \u 目录 1 正文 1 文1：罗红霉素胶囊在人体的药代动力学及生物等效性 1 1 材料与方法 2 2 结果 4 3 讨论 6 文2：盐酸曲马多片人体药代动力学和生物等效性 7 1对象和方法 7 参考文摘引言： 12 原创性声明（模板） 12 文章致谢（模板） 13 正文 罗红霉素胶囊在人体的药代动力学及生物等效性 文1：罗红霉素胶囊在人体的药代动力学及生物等效性 Pharmacokinetics and bioequivalence of roxithromycin capsules in human ABSTRACT: Objective To establish the method of assaying roxithromycin in human plasma by high performance liquid chromatography (HPLC), and to study its pharmacokinetics and bioequivalence. Methods The plasma samples were extracted by hexane isoamylalcohol (98∶2) and reveed phase chromatography to determine the concentration of roxithromycin. Results The calibration curve was linear from /L to /L, the minimum concentration was /L(r=) and the minimum quantitation was . The extraction recovery rate was %-% and the method recovery rate was %-%. After a single oral dose of 300mg roxithromycin test or reference capsules, the main pharmacokinetic paramete were as follows: AUC0-48h(±)(mg·h)/L and (±)(mg·h)/L, Cmax(±)mg/L and (±)mg/L, tmax(±)h and (±)h, t1/2(±)h and (±)h, respectively. Relative bioavailability of the test fomulation was (±)%. Conclusion This method can be used in the analysis of roxithromycin in the plasma without endogenic substance interference. The method is specific and accurate. No significance difference exists among the main pharmacokinetic paramete for the test capsules and the reference capsules. The two formulatio are bioequivalent. KEY WORDS: roxithromycin; high performance liquid chromatography (HPLC); bioequivalence; pharmacokinetics 罗红霉素是半合成的十四元大环内酯类抗生素，具有口服吸收好、半衰期长等特点。在较低波长处，罗红霉素具有较高的吸收，可采取分光光度方法检测。本实验采用高效液相色谱法(high performance liquid chromatography, HPLC)测定血浆中罗红霉素的含量，最低检测浓度为/L，可满足罗红霉素药动学的研究。此方法简便迅速，结果准确。 1 材料与方法 药品、试剂与仪器 受试制剂：罗红霉素胶囊(T)，规格：150mg/粒，批号：030701，山东天顺药业股份有限公司生产。参比制剂：罗红霉素胶囊(R)，规格：150mg/粒，批号：，江苏扬子江药业集团有限公司。罗红霉素对照品含量946u/mg，批号：30351-200303，由 中国 药品生物制品检定所提供。试剂：甲醇由美国Fishe公司生产，色谱纯；正己烷由德国Merck公司生产，色谱纯；异戊醇以及其余试剂均为分析纯