国产注射用盐酸米诺环素人体药动学研究.docVIP

国产注射用盐酸米诺环素人体药动学研究 目录 TOC \o 1-9 \h \z \u 目录 1 正文 1 文1：国产注射用盐酸米诺环素人体药动学研究 1 1 材料与方法 3 2 结果 5 3 讨论 5 文2：国产注射用比阿培南人体药动学研究 6 1 材料与方法 7 2 结果 10 3 讨论 10 参考文摘引言： 11 原创性声明（模板） 12 文章致谢（模板） 13 正文 国产注射用盐酸米诺环素人体药动学研究 文1：国产注射用盐酸米诺环素人体药动学研究 Pharmacokinetics of minocycline hydrochloride for injection in healthy human ABSTRACT Objective To study the pharmacokinetics of minocycline hydrochloride for injection in healthy human. Methods Twelve healthy voluntee were selected to receive a single dose of minocycline 100, 200 and 300mg within 2h infusion in an open randomized threefold crossover study. There was a week washout in every project. Blood samples were taken for detecting serum concentration before administration and at 0, 025, 05, 075, 1, 15, 2, 4, 6, 8, 12, 24，48, 72h after completion of the intravenous infusion. The concentratio of minocycline in serum were determined by a highpressure liquid chromatography (HPLC) method. Results Pharmacokinetic profiles were conformed to an open twocompartment model analyzed by using 3P97 and the result of HPLC method were as follows: the Cmax of 100, 200, 300mg minocycline at the end of infusion were (311±067)μg/ml, (709±189)μg/ml and (1180±285)μg/ml; the AUCs were (5098±1365)μg#12539;h/ml, (9385±1782)μg#12539;h/ml and (16360±3169)μg#12539;h/ml; the t1/2α were (113±062) h, (075±044)h and (071±041)h; the t1/2β were (1784±597)h, (1405±260)h and (1416±172)h; the CLs were (211±063)L/h, (220±040)L/h and (190±034)L/h; the Vc were (2544±617)L, (1948±940)L and (1803±724)L, respectively KEY WORDS Minocycline hydrochloride for injection; Pharmacokinetics; Revee phase high pressure liquid chromatography 米诺环素(minocycline)属半合成四环素类药物，又名二甲胺四环素，首先由美国氰胺公司立达大药厂研制并于20世纪70年代上市，现已有胶囊、片剂、口服液等多种剂型。米诺环素是半合成长效四环素，广谱抗生素，以其对氨酰基转移RNA与RNA核糖体复合体上受体位点结合的阻滞作用干扰细菌蛋白质合成，对革兰阳性菌、革兰阴性菌、立克次体和衣原体等均有抗菌作用，对感染性疾病有较好 治疗 作用，安全性已被临床实践所证实［1］。该药的注射剂国内尚未使用。本文首次采用高效液相色谱法测定血清中米诺环素的浓度，研究注射用盐酸米诺环素在人体内的药动学过程，为临床合理用药提供依据。 1 材料与方法 药品与试剂注射用盐酸米诺环素(批号)为