Venlafaxine HCl 緩釋劑型處方研發

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標題:	Venlafaxine HCl 緩釋劑型處方研發 The formulation study of sustained release Venlafaxine HCl
作者:	張銘聰 Ming-Tsung Chang
貢獻者:	陳俊仁嘉南藥理科技大學：生物科技研究所
關鍵字:	緩釋小圓粒 Venlafaxine HCl Sustained release Pellet
日期:	2007
上傳時間:	2008-12-03 11:15:15 (UTC+8)
摘要:	憂鬱不只是一個問題和現象而已，它更是真實的一種疾病，帶給患者一種破壞性的傷害。Venlafaxine HCl 是最新的抗憂鬱藥品，藥理學上是屬於SNRI (Serotonin/Norepinephrine Reuptake Inhibitor)藥品，在焦慮與憂鬱症之療效上及安全性皆受到重視，市場上頗受精神科醫師與病人的歡迎。本研究旨在以製劑學技術，將高水溶性之Venlafaxine HCl製成每顆含75 mg (Venlafaxine base)緩釋膠囊，將可此藥的投遞次數從每天三次減為每天一次，以增進病人之用藥順從性，因此將可維持病人穩定的治療效果。　在本製劑的製程中，以HPMC、Avicel為主要賦形劑，經過混合、擠壓、製粒、搓圓等步驟製成圓粒，以aquacoat ECD30為主要包衣原料。包衣後經充填至膠囊。但在製作之前，先以分子量相近且易溶於水之 B 1作為預試材料。所製成膠囊再依中華藥典第五版之規定，進行重量差異、均一度分析與在三種酸鹼度(pH 1.2、pH 4.5及pH 6.8)溶離媒液中之溶離試驗，其緩釋原理為擴散作用。結果顯示其重量差異為321.46 ± 0.59 mg (n=10；CV=0.18%)；均一度含量試驗為87.29 ± 3.16 mg (Venlafaxine HCl ; n=10; CV=3.62%)；在pH 1.2、pH 4.5及pH 6.8之溶離媒液中與原廠藥”Efexor 75mg XR”比較溶離相似度(F2值；N=3)，結果分別為79.2、76.25及56.34。在製粒過程之中，需要加入酒精及A成分之混合液當溶劑，才易完成製粒。aquacoat ECD30 需要包衣兩次才能達到緩釋效果。由所得各種數據推論，本研究所產製的「Venlafaxine HCl」緩釋膠囊應與原廠藥”Efexor 75mg XR”在溶離試驗中相似。 The depression is not only a problem and phenomenon but also a real disease. It brings a destructive injury to patients. Venlafaxine is the newest anti-depression medicine. In the pharmacology, it is a kind of SNRI (Serotonin/Norepinephrine Reuptake Inhibitor) medicine. Due to its curative effect of the depression and safety on the anxious, it is very popular to doctors of psychiatric units and patients in the market. This research studied the technology of making high water soluble Venlafaxine HCl into a sustained release capsule containing 75 mg Venlafaxine base pellets. This would reduce the use of this medicine from three times per day to once. Therefore, the treatment of a patient would be more acceptable. In the pellet preparation, Avicel acted as the main excipient and via mixing, extrusion, rounding to form the pellets. Finally, a capsule was filled with these pellets after they were coated with aquacoat ECD30. B 1 hydrochloride was used as a testing ingredient in the beginning as it is cheaper, water-soluble and has a similar molecular weight with venlafaxine. According to the fifth edition of pharmacopoeia in Taiwan, the weight variation and the dissolution test in three different pH values (pH 1.2, 4.5, and 6.8) of these capsule were carried. The average weight is 321.46 ± 0.59 mg (n =10; CV =0.18%) and equivalent to venlafaxine base 87.29 ± 3.16 mg (Venlafaxine HCl; n =10; CV =3.62%). The comparison of dissolution profiles with the brand name product Efexor 75mg XR shows the f2 values to be 79.2 , 76.25 and 56.34 respectively for pH 1.2、pH 4.5 and pH 6.8 environment. Therefore, it can be concluded that this product of Venlafaxine HCl should be similar to the original brand name product " Efexor 75mg XR " in the dissolution profile.
關聯:	校內一年後公開，校外永不公開
显示于类别:	[生物科技系(所)] 博碩士論文

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