黄体酮的热特性分析黄体酮的热特性分析.pdfVIP

— —— — 1994．．—— 药物分析杂志Chin J Pharm Anal 2007，27(12) 黄体酮的热特性分析 虞和永 ，钱晓丹 ，杨腊虎 ，陈唯真 (1．浙江大学医学院附属妇产科医院，杭州310006；2．中国药品生物制品检定所，北京10050) 摘要 目的：观察黄体酮药物的热特性，并测定其纯度。方法：利用差示扫描量热法(DSC)和导数热重法(DTG)测定黄体酮的 熔点、纯度及挥发性物质，在氮气氛下升温速率分别为1．5，10，20℃·min～。结果：用差示扫描量热法，升温速率为1．5℃· min～，测定黄体酮的熔点为130℃，在程序控温下对其吸热峰进行分析，其纯度为99．8％，与高效液相色谱测定的结果 (99．9％)一致。用导数热重法可准确测定其挥发性物质包括水分在内的变化，以及推测其降解历程。结论：该分析法简便、 快捷，可测定黄体酮的晶型、水分及纯度，并为研究降解机理及开发新剂型提供参考。 关键词：黄体酮，差示扫描量热法，热重分析法 中图分类号：R917 文献标识码：A 文章编号：0254—1793(2007)12—1994—02 Determination of progesterone of the thermal characteristic using thermal analysis YU He—yong ，QIAN Xiao—dan ，YANG La—hu ，CHEN Wei—zhen (1．Obestetric and Gynecology Hospital，Zhejiang University，Hangzhou 310006，China； 2．National Institute for the control of Pharmaceutical and Biological Products。Beijing 10050。China) Abstract Objective：The thermal behaviour and purity of progesterone were investigated using thermal analytical techniques．Method：differentical scanning calorimetry(DSC)，thermogravimetric analysis(TGA)are used for determi· nation molting point，purity and volatile solvent at increasing temperature rate of 1．5，10 and 20℃ 。min一，under the atomosphere of nitrogen，respectively．Results：The melting point of progesterone Was 130℃ ，and the purity of proges· terone Was more than 99．8％ determined by DSC at a increasing temperature rate of 1．5℃ ·min一．which was 8alTle as result(99．9％ )measured by HPLC．Exotheric peak appeared in the thermogram．TAG could determine accurafly volatile solvent(including water)in progesterone and infer the degradation process of progesterone．Conclusion：Ther- mal analytical techniques can apply for determination of polyinorphish，water and purity of progesterone and supply reference to study degradation mechanism and to develop new dosage form． Key words：progesterone；differ