氯化钾缓释片药动学及影响因素研究-制药工程专业毕业论文.docxVIP

山东人学硕I：学位论文结果：l火焰原子吸收分光光度法测定尿液中钾离子浓度，钾离子在O．05一 山东人学硕I：学位论文 结果：l火焰原子吸收分光光度法测定尿液中钾离子浓度，钾离子在O．05一 2mg·mL1范围内线性关系良好(r--O．9994)，绝对回收率和相对回收率分别为 (80．3—85．3)％和(93．5～113．1)％，日内和日间RSD分别小于8．2％和9．5％， 钾离子在-20℃存放一周及经过两次冻融稳定。2氯化钾缓释片试验制剂与参比 制剂主要药代动力学参数tl亿分别为(3．566+1．695)h和(3．9634-1．875)h，尿最 大排泄量Amax分别为(7．70士1．76)mmol和(7．114-2．20)mmol，Tmax分别为 (5．44-2．3)h和(4．34-3．O)h，24h尿累积排泄总量分别为(28．524-5．22)mmol 和(27．884-4．69)mmol。试验制剂氯化钾缓释片相对生物利用度F(以钾离子计) 为(103．64．20．1)％。 结论：l本文建立的火焰原子吸收分光光度法快速、简单、灵敏、准确，适 用于人尿液中钾离子浓度测定。2试验制剂氯化钾缓释片人体相对生物利用度F 为(103．6±20．1)％。3多因素方差分析显示，氯化钾缓释片试验制剂和参比制 剂单剂口服给药双交叉试验主要药代动力学参数药物间和周期间无显著性差异， 但个体间存在统计学差异。进一步双单侧t检验和(卜2 a)置信区间分析个体 间、周期间和剂型间符合生物等效的假设，即试验制剂氯化钾缓释片与市售参比 制剂氯化钾缓释片具有生物等效性，为生物等效制剂。 关键词：氯化钾缓释片；生物等效性；生物利用度；火焰原子吸收分光光度 法；尿液 2 山东人学硕I：学位论文STUDIES 山东人学硕I：学位论文 STUDIES oN PHARM睑Col(INETICS oF PoTASSIUM CHLoRIDE SUSTAINED．RELEASE TABLETS AND THE INFLUENCING FACToRS Postgraduate：Niu Xiaofang Major：Pharmaceutical Engineering Tutor：Prof．Guo Ruichen ABSTRACT objective：1．To establish a flame atomic absorption spectrophotometry method for the determination of potassium ion in human urine．2．To study the pharmacokinetics and bioavailability of potassium chloride sustained—release tablets in healthy volunteers，and to evaluate its characteristics of absorption，distribution,elimination and excretion kinetics．To observe the possible influencing factors on the absorption, distribution and elimination of potassium ion and to provide evidence for its reasonable clinical applications． Methods：1．Urine samples were disposed and detected by flame atomic absorption spectrophotometry method．Lamp current was 4mA．Detection wavelength Was 766．5nm．Band pass width was O．5nm．Flame style Was Air-C2H2．Flow rate of burning gas Was 1．2L·min1．Height of burner Was 7．0mm．2．20 healthy male volunteers were divided into two groups randomly according to two period U-TOSS—OVer test design．Volunteers were orally given the test or reference preparation of potassium chloride tablets during the two periods．E