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盐酸文拉法辛固体口服缓释制剂的制备

时间:2018-01-08 18:33来源:毕业论文
论文的主要内容是以盐酸文拉法辛为主要原料,以羟丙甲基纤维素和甲基纤维素作为辅料,制备缓释胶囊
摘要:盐酸文拉法辛,全称:(R/S)-1-[2-(二甲胺)-1-(4-甲氧苯基)乙基]环己醇盐酸盐。属于苯乙胺类药物。盐酸文拉法辛作为一种新型抗抑郁药物,由于其疗效肯定、起效快、副作用小、耐受性好,而备受关注。缓释制剂能够提供平稳、持久的血药浓度,将药物在体内的释放时间相对延长,吸收和药物的分布情况相对较好。本重庆时时彩的规律的主要内容是以盐酸文拉法辛为主要原料,以羟丙甲基纤维素和甲基纤维素作为辅料,制备缓释胶囊。主要结果如下: (1)建立了盐酸文拉法辛的定量分析方法。采用紫外分光光度法,测得盐酸文拉法辛的最佳吸收波长为272nm;其他相关辅料在该波长处均无吸收峰;分别考察了盐酸文拉法辛在水、0.1mol•L-1盐酸溶液、PH=5.0磷酸盐缓冲液、PH=6.8磷酸盐缓冲液中的回收率,得到回收率分别为101.51、100.20、100.47、100.37%;考察了方法的精密度,得到RSD为1.53%,精密度良好;考察了溶液的稳定性,得到RSD为1.03%,稳定性亦良好。      (2)考察了盐酸文拉法辛缓释胶囊的制备工艺。分别考察了辅料种类、辅料配比、制粒目数、助流剂的加入量对盐酸文拉法辛胶囊的影响,并得到最佳制备处方为:选择羟丙甲基纤维素和甲基纤维素作为辅料,加入量分别为羟丙甲基纤维素100mg、甲基纤维素25mg;助流剂微粉硅胶加入2.5%;过16目的药筛制粒,制备得到的盐酸文拉法辛胶囊符合国家药典关于缓释体外溶出度的要求。17191
(3)考察释放介质对盐酸文拉法辛缓释胶囊体外溶出曲线的影响。本文所制备的盐酸文拉法辛胶囊在pH=6.8的磷酸缓冲盐溶液中有良好的溶出曲线,其体外溶出曲线经拟合后符合一级动力学方程。
关键词:盐酸文拉法辛;缓释;体外溶出;紫外分光光度 源自六/维\论]文[网!加7位QQ324.9114 重庆时时彩的规律 www.mamitama.com
Preparation of Oral Solid Sustained-Release Formulation of Venlafaxine Hydrochloride
Abstract: Venlafaxine hydrochloride, chemical name: (R/S)-1-[2-(dimethylamine)-1-(4-a oxygen phenyl) ethyl] cyclohexano hydrochloride. It belongs to benzene procedures. As a new type of antidepressant drug, because of its curative effect ,working quickly, low side effects , great tolerance, so that it has been concerned. Sustained release preparation provides stable and durable drug concentration in blood, the drug release in vivo is a relatively extended period, as a result,the absorption and drug distribution will be relatively better. The main content of this thesis is to take the Venlafaxine hydrochloride as main raw materials, with hydroxypropyl methyl cellulose and methyl cellulose as the main accessories to make these capsules. The following tips are the contest:
(1) To established the quantitative analysis method of venlafaxine hydrochloride. The ultraviolet spectrophotometry of venlafaxine hydrochloride, measured the best absorption wave length, is 272nm; other related accessories in the wave length have no absorption peak of 272nm; Recovery rates were investigated in water; 0.1mol•L-1hydrochloric acid solution; PH=5.0 phosphate buffer solution and PH=6.8 phosphate buffer solution, recovery rates were101.51, 100.20, 100.47, 100.37%; To examine the precision , so RSD is 1.53%, precision is good; To examine the solution stability, the RSD 1.03%,which is good stability.
(2) To study of venlafaxine hydrochloride sustained-release capsule and its preparation technology. Different accessories, the ratio of accessories, granulating mesh, flow agent dosage on the effects of venlafaxine hydrochloride capsules, and get the best preparation prescription : choice hydroxypropyl methyl cellulose and methyl cellulose as material, adding quantity of hydroxypropyl methyl cellulose, methyl cellulose were 100mg and 25mg; flow agent silica powder were added in 2.5%;the NO.16 medicine sieve granulator, obtained by the preparation of venlafaxine hydrochloride capsules meet  with the national pharmacopoeia on release in vitro dissolution requirements. 盐酸文拉法辛固体口服缓释制剂的制备:/a/yixue/20180108/18767.html
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