期刊文献+

烟酸缓释片的生物等效性研究 被引量:2

Study on Bioequivalence of Nicotinic Acid Sustained-Release Tablets
下载PDF
导出
摘要 目的建立烟酸血浆浓度测定法,并进行该药的生物等效性研究。方法采用随机双交叉设计,30例健康受试者口服国产烟酸缓释片(受试制剂)和进口烟酸缓释片(参比制剂)各1 500 mg,采用高效液相色谱-质谱串联法测定血浆中烟酸浓度。结果受试制剂与参比制剂的药-时曲线下面积(area under the curve,AUC0→15)分别为(20 046.1±16 286.8)和(21 605.0±18 058.5)ng.h.mL-1,AUC0→∞分别为(20 806.0±16 300.7)和(22 811.2±18 468.3)ng.h.mL-1;Cmax分别为(8 716.3±6 811.2)和(9 570.2±8 217.1)ng.mL-1;tmax分别为(4.414±1.337)和(4.310±1.285)h;t1/2分别为(4.000±4.898)和(2.906±3.393)h。受试制剂的相对生物利用度为(96.6±30.9)%。结论国产烟酸缓释片与进口烟酸缓释片具有生物等效性。 Objective To establish a method for determination of nicotinic acid in human plasma and study its bioequivalence in Chinese healthy volunteers. Methods Thirty healthy volunteers were orally administered with 1 500 mg nicotinic acid(test) tablets in a randomized crossover design.The drug levels in plasma samples were determined by a HPLC-MS/MS method. Results The main pharmacokinetic parameters of the test and reference preparations were as follows:AUC0→15 was(20 046.1±16 286.8),(21 605.0±18 058.5) ng·h·mL-1,AUC0→∞ was(20 806.0±16 300.7) and(22 811.2±18 468.3) ng·h·mL-1;Cmax was(8 716.3±6 811.2) and(9 570.2±8 217.1) ng·mL-1;tmax was(4.414±1.337) and(4.310±1.285) h;t1/2 was(4.000±4.898) and(2.906±3.393) h.The relative bioavailability of the test tablet was(96.6±30.9) %. Conclusion The domestically made nicotinic acid tablets and those imported are bioequivalent.
出处 《医药导报》 CAS 2011年第11期1432-1434,共3页 Herald of Medicine
关键词 烟酸 药动学 生物等效性 高效液相色谱-质谱串联法 Nicotinic acid Pharmacokinetics Bioequivalence HPLC-MS/MS
  • 相关文献

参考文献4

二级参考文献23

共引文献19

同被引文献18

  • 1范新华,屠永锐,胡一桥.自制复方洛伐他汀-烟酸缓释片及其人体药动学研究[J].世界临床药物,2009,30(12):739-745. 被引量:3
  • 2王萍,顾世芬,杨德隆,吴贵宝,李铃,陈汇.烟酸缓释片的人体药代动力学及相对生物利用度[J].中国药师,2005,8(2):94-96. 被引量:7
  • 3李祎.烟酸缓释胶囊家犬体内药动学及相对生物利用度研究[J].现代食品与药品杂志,2006,16(5):30-32. 被引量:1
  • 4Pfuhl P,Karcher U,Haringa N. Simultaneous determination of niacin,niacinamide and nicotinuric acid in human plasma[J].Journal of Pharmaceutical and Biomedical Analysis,2005,(02):1045-1052.
  • 5Christopher SV,Ramadan AH,Sameer HN. Revisiting niacin:reviewing the evidence[J].Journal of Clinical lipidology,2007,(04):248-255.
  • 6Abbott Laboratories. Advicor" (niacin extended-release/lovastatin tablets) [EB/OL]. [2014-07-01]. http://www.advicor.com/important- safety-information.asp.
  • 7Pfuhl P, K~ircher U, H~iring N, et al. Simultaneous determination of niacin, niacinamide and nicotinuric acid in human plasma[J]. ] Pharm Biomed Anal, 2005, 36(5): 1045-1052.
  • 8Lauring B, Rosko K, Luo WL, et al. A comparison of the pharmacokinetics of two different formulations of extended-release niacin[J]. Curt Med Res Opin, 2009, 25(1): 15-22.
  • 9Zhang P, Sun Y, Shi G, et al. Quantification of niacin and its metabolite nicotinuric acid in human plasma by LC-MS/MS:application to a clinical trial of a fixed dose combination tablet of niacin extended-release/simvastatin (500 mg/10 mg) in healthy Chinese volunteers[]]. Int ] Anal Chem, 2015: 212437.
  • 10Liu M, Zhang D, Wang X, et al. Simultaneous quantification of niacin and its three main metabolites in human plasma by LC- MS/MS[I]. ] Chromatogr B Analyt Technol Biomed Life Sci, 2012, 904(2): 107-114,.

引证文献2

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部