氨甲环酸分析测试方法研究进展.pdf

氨甲环酸分析测试方法的研究进展  1,2 1,3 1,3 1,2 3 1* 王霞 ，王琼 ，江爱 ，胡焰 ，邱细敏 ，李健和 (1.中南大学湘雅二医院药学部，长沙 410011 ；2. 中南大学药学院， 长沙 410013 ；3.湖南师范大学，长沙 410012) 摘要：目的 介绍氨甲环酸分析测试方法的研究进展，供药品质控、新药开发、药动学以及生物等效性研究参考，确保 药品质量和临床用药安全。方法 查阅近20 年的国内外文献，对氨甲环酸分析测试方法进行概述。结果 氨甲环酸制剂 以及体液的分析测试方法主要有容量分析法、光谱分析法、色谱分析法、核磁共振波谱法等。结论 氨甲环酸的检测方 法在不断提高，为促进临床安全合理用药及进一步开发新型的氨甲环酸药物制剂提供依据与参考。 关键词：氨甲环酸；制剂分析；体液分析 中图分类号：R917 文献标志码：A 文章编号：1007-7693(2014)07-0900-07 DOI: 10.13748/ki.issn1007-7693.2014.07.034 Research Progress of Tranexamic Acid Analysis Methods 1,2 1,3 1,3 1,2 3 1* WANG Xia , WANG Qiong , JIANG Ai , HU Yan , QIU Ximin , LI Jianhe (1.Department of Pharmacy, the Second Xiangya Hospital of Central South University, Changsha 410011, China; 2.Pharmacy of Central South University, Changsha 410013, China; 3.Hunan Normal University, Changsha 410012, China) ABSTRACT: OBJECTIVE To introduce the analysis methods of tranexamic acid for the reference of drug quality control, development of new drugs, pharmacokinetics, bioequivalence study, and to ensure the quality of medicines and the safety of clinical drug application. METHODS Domestic and foreign literatures in recent 20 years were consulted to provide an overview of tranexamic acid analysis methods. RESULTS The analysis methods of tranexamic acid preparation and body fluids included volumetry, spectroscopy, chromatography, nuclear magnetic resonance spectroscopy, etc. CONCLUSION The analysis methods of tranexamic acid are constantly improved to provide references of using medicines reasonably and safely, and further developing new pharmaceutical formulations of tranexamic acid. KEY WORDS: tranexamic