磷酸川芎嗪包衣缓释滴丸制备的研究.doc

PAGE  PAGE 18 磷酸川芎嗪包衣缓释滴丸制备的研究 摘要：本研究根据磷酸川芎嗪代谢快、半衰期短的特点，将其研制成缓释包衣滴丸，使其具有持效性，方便用药，使血药浓度平稳，降低副作用，主要用于凌晨易发作疾病如心绞痛、脑梗塞的预防。本研究采用聚乙二醇6000（PEG6000）和聚乙二醇400（PEG400）为作为滴丸基质通过摸索得出合适的处方将其制成滴丸丸心，然后用乙基纤维素（EC），丙烯酸树脂高渗（RL）和丙烯树脂低渗(RS)，邻苯二甲酸二乙酯（DEP）为包衣材料，95%的乙醇为包衣溶剂，对其进行包衣，并考察了各因素对磷酸川芎嗪缓释滴丸释放度的影响。数据显示本药物制剂的释放速度受EC,丙烯酸树脂的用量和包衣厚度的影响比较大，受药物的含药量，DEP的用量及包衣液的浓度的影响比较小。 关键词：磷酸川芎嗪；缓释；滴丸；包衣 STUDY ON LIGUSTRAZINE PHOSPHATE SLOW RELEASE DROP PILL Abstract: This study in order to retrieve the disadvantages of short HWZ and fast metabolism of Ligustrazine Phosphate that it has been made into coating slow release drop pill .Because of this new dosage form the drug action would be kept longer. It is convenient to cpalend, safety and no side reaction. Which was in order be used to preventing the patients from subjecting with the disease of angina cordis and cerbral infarction.PEG6000 and PEG400 were used as the adjuvant of the drop pill and we have found out the method that how to make the drop pills and also found out the anagraph of coating liquid which were made from ethocel (EC), Eudragit RS(Rs) 100, Eudragit RL100 (RL), diethyl phthalate(DEP),EtOH95%.We have investigated all the factors of the coating slow release drop pill in order to find out which factor play the important role on the release speed .The result shows that release speed are effected by EC, RL, RS, coating thickness manifest but DEP and the concentration of the coating solution. Keyword: Ligustrazine Phosphate slow release drop pill coating 目录  TOC \o 1-3 \h \z \u  HYPERLINK \l _Toc229296980 1 前言  PAGEREF _Toc229296980 \h 6  HYPERLINK \l _Toc229296981 1.1磷酸川芎嗪的物理性质和药理作用  PAGEREF _Toc229296981 \h 7  HYPERLINK \l _Toc229296982 1.2磷酸川芎嗪的药代动力学  PAGEREF _Toc229296982 \h 8  HYPERLINK \l _Toc229296983 1.3磷酸川芎嗪制剂的概况  PAGEREF _Toc229296983 \h 8  HYPERLINK \l _Toc229296984 1.4缓控释制剂的发展及类型  PAGEREF _Toc229296984 \h 8  HYPERLINK \l _Toc229296985 1.5缓控释包衣滴丸的优点和缺点  PAGEREF _Toc229296985 \h