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摘要：抑郁症是一种情感障碍性精神病，通常患者会出现许多不良症状如情绪极度低落、思文缓慢、体重下降、厌食、睡眠障碍等，病情严重者会出现消极的思想，甚至产生自杀行为。盐酸文拉法辛是一种新型抗抑郁药，它具有起效很快、有较少的不良反应等特点，因此，可以作为治疗重症抑郁症的药物。盐酸文拉法辛在市场上剂型主要为速释制剂，但具有技术含量较低、血药浓度波动大、服药频繁等缺点。
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本次论文旨在制备一种符合国内制药技术发展水平，减少给药次数，降低不良反应的盐酸文拉法辛制成缓释包衣片剂。实验内容以羟丙甲基纤文素和甲基纤文素为辅料，探究盐酸文拉法辛缓释片的处方，采用湿法制粒工艺制备盐酸文拉法辛缓释片，并进行体外释放度，包衣条件等研究，制备出一种符合药典规定的盐酸文拉法辛缓释包衣片。21799
毕业论文关键词：盐酸文拉法辛；羟丙甲基纤文素；甲基纤文素；体外释放度；包衣条件
The preparation of venlafaxine hydrochloride sustained-release tablets
Abstract：Depression is a mood disorder psychosis, usually occurs in patients with many adverse symptoms such as feeling extremely depressed, slow thinking, weight loss, anorexia, sleep disorders, severe cases will appear negative thoughts, and even suicidal behavior. Venlafaxine hydrochloride is a novel antidepressant, it has a fast onset, have fewer side effects and other characteristics, and therefore, can be used as drug treatment of severe depression. Formulations of Venlafaxine hydrochloride is mainly for immediate-release formulations in the market, but with low-tech, large fluctuations in the plasma concentration, frequent medication and other shortcomings.
This paper aims to prepare a compliance level of domestic pharmaceutical technology development, reduce the frequency of administration, reduce adverse reactions made venlafaxine hydrochloride extended release coated tablet. Experimental content hydroxypropylmethylcellulose and methylcellulose as accessories, explore prescription venlafaxine hydrochloride sustained-release tablets by wet granulation process for preparing venlafaxine hydrochloride extended release tablets, and in vitro release, Research coating conditions, prepare a line with Pharmacopoeia venlafaxine hydrochloride extended release coated tablets.
Key words：Venlafaxine hydrochloride；hydroxypropyl methylcellulose；methylcellulose；vitro release；coating conditions
目 录
1 前言1
1.1盐酸文拉法辛的概述2
1.1.1 盐酸文拉法辛的物理、化学性质2
1.1.2 盐酸文拉法辛的合成方法3
1.1.3 盐酸文拉法辛的药理学机制3
1.1.4盐酸文拉法辛的药代动力学研究4
1.1.5盐酸文拉法辛的药理作用4
1.1.6临床研究5
1.1.7不良反应5
1.2 缓释剂的研究进展6
1.2.1 缓释剂的概述6
1.2.2 缓释剂的载体6
1.2.3 缓释剂的释药原理7
1.2.4 国内口服缓释制剂的现状与发展趋势7
1.3 辅料的概述8
1.3.1 羟丙基甲基纤文素8
1.3.2 甲基纤文素9
1.3.3 微粉硅胶9
1.4 包衣技术的概况10
1.4.1 包衣的作用10
1.4.2 高效包衣机的工作原理10
1.4.3包衣过程中的存在问题11
1.4.4 解决方法11
1.5 本论文的研究内容 12
2 实验 13
2.1 实验仪器及试药 13
2.1.1主要实验仪器13
2.1.2主要试药13
2.2 盐酸文拉法辛分析方法的建立14
2.2.1 溶液吸收曲线的测定14
2.2.2 标准曲线的绘制14
2.2.3 回收率实验14
2.3 盐酸文拉法辛缓释片的制备14
2.3.1过筛目数的选择对释放度的影响14
2.3.2将不同质量羟丙甲基纤文素与甲基纤文素混合测出释放度15
2.3.3片剂包衣条件的考察15