异烟肼缓释固体分散体制备与其体外评价.PDFVIP

·药 剂 · 异烟肼缓释固体分散体的制备及其体外评价 刘颖1,2 1,3 1 2 1* ，常江 ，韩美华 ，阎雪莹 ，王向涛 (1.中国医学科学院药用植物研究所，北京 100193 ；2.江西中医学院，南昌 330004 ； 3.黑龙江中医药大学，哈尔滨 150040) 摘要：目的 制备异烟肼缓释固体分散体，考察其分散状态和体外溶出速率。方法 以水不溶性聚合物乙基纤维素为载 体，用溶剂法制备异烟肼缓释固体分散体。采用X 射线衍射法、差示扫描量热法和红外光谱法鉴别药物在固体分散体中 的存在状态，并对其体外释放情况进行研究。结果 X 射线衍射法表明异烟肼在固体分散体中有一部分是以分子状态分 散，而另一部分可能以微晶体状态分散；差示扫描量热法表明所制备的缓释固体分散体中不存在药物结晶；红外光谱法 结果表明异烟肼与乙基纤维素未发生化学反应；溶出度试验结果表明其具有良好的缓释效果。结论 采用溶剂法制备的 异烟肼缓释固体分散体可以使药物达到高度分散状态，制备的异烟肼缓释固体分散体具有较好的缓释效果。 关键词：异烟肼；乙基纤维素；固体分散体；X 射线衍射法；差示扫描量热法；红外光谱法 中图分类号：R943.41 文献标志码：B 文章编号：1007-7693(2011)02-0142-04 Preparation and in Vitro Release Evaluation of Isoniazid Solid Dispersion 1,2 1,3 1 2 1* LIU Ying , CHANG Jiang , HAN Meihua , YAN Xueying , WANG Xiangtao (1.Chinese Academy of Medical Sciences Peking Union Medical College Institute of Medicinal Plant Development, Beijing 100193, China; 2.Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China; 3.Heilongjiang University of Chinese Medicine, Harbin 150040, China) ABSTRACT: OBJECTIVE To prepare and identify sustained-release of isoniazid solid dispersion(SD) and evaluate its in vitro dissolution profile. METHODS The isoniazid SD was prepared by using water-insoluble polymer ethyl cellulose (EC) as carrier. X-ray diffraction, differential scanning calotimetery (DSC) and infrared spectroscopy (IR) were used to evaluate the dispersing state of isoniazid in SD and in vitro dissolution of isoniazid SD was performed. RESULTS X-ray diffraction analysis showed that the isoniazid was existed in both molecuar and micro-crystal form. DSC curve indicated that there was no isoniazid crystal in the SD. IR spectrum showed that there was no chemical