柳氮磺吡啶肠溶片人体生物等效性研究

梁燕; 王凌; 王蕊; 常臻; 钟延强; 邹豪; 梁燕; 王凌; 王蕊; 常臻; 钟延强; 邹豪

doi:10.3969/j.issn.1006-0111.2013.06.007

[1]

CDER/FDA. Guidance for Industry, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, March 2003.http://www.fda.gov/downloads/Drugs/Guidance Compliance Regulatory Information/Guidances/UCM070124.pdf.

[2]

FDA. Draft Guidance on Sulfasalazine,Feb 2010.http://www.fda.gov/downloads/Drugs/Guidance_Compliance_Regulatory_Information/Guidances/UCM199673.pdf.

[3]

李金恒,刘存刚,姚旋,等.HPLC梯度洗脱法测定血浆中柳氮磺吡啶及其代谢物[J].医学研究生学报, 2008, 7(21):682.

[4]

白小红,胡爽,李进霞,等.高效液相色谱法测定人血浆中柳氮磺胺吡啶及其代谢物[J].中国医院药学杂志,2004,24(4):208.

[5]

Ma JJ,Liu CG,Li JH,et al. Effects of NAT2 polymorphism on SASP pharmacokinetics in Chinese population[J].Clin Chem Acta,2009,407:30.

[6]

Gu GZ,Xia HM,Pang ZQ,et al.Determination of sulphasalazine and its main metabolite sulphapyridine and 5-aminosalicylic acid in human plasma by liquid chromategraphy/tandem mass spectrometry and its application to a pharmacokinetic study[J].J Chromtog B,2011,879:449.