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研究生:洪馨霞
研究生(外文):Hsin-hsia Hung
論文名稱:潤滑劑與滑動劑存在下膠原蛋白對崩散劑吸水行為之影響
論文名稱(外文):Influence of Collagen on the water-uptake behaviors ofvarious disintegrants in the presence of lubricant and glidants
指導教授:王澤川
指導教授(外文):Tzer-Chuan Wang
學位類別:碩士
校院名稱:大仁科技大學
系所名稱:製藥科技研究所
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2008
畢業學年度:96
語文別:中文
論文頁數:124
中文關鍵詞:吸水行為膠原蛋白崩散劑潤滑劑滑動劑
外文關鍵詞:lubricantdisintegrantcollagenglidantwater uptakeIbuprofen
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膠原蛋白(Collagen)是一種普遍存在於人體內的醣蛋白(Glyco-protein),主要是以不溶性纖維蛋白的形式存在,是人體內重要成分,與人體有著密不可分的關係。在應用上,因膠原蛋白的吸水性,經常被當作保濕劑使用。
另一方面,時至今日,藥物劑型仍以固體製劑為主流,其中錠劑之療效是否能確實發揮,主要由崩散劑控制的崩散作用是重要的步驟。而崩散劑作用之發揮,吸取水分(water-uptake)是必要的過程,又為使製程順利,在其處方中大多含有少量的潤滑劑及滑動劑等。
本研究基於膠原蛋白的低免疫性(low immungenicity)及易吸水之特性,利用虹吸現象及水位平衡之設備,以吸水行為(Water-uptake behavior)為指標,檢討崩散劑與潤滑劑及滑動劑之間的交互作用是會受到膠原蛋的的影響,及疏水性有效成分,是否可以改變此等影響。
在本研究中,以0.1N HCl溶液為媒質,在潤動劑(Magnesium stearate、Stearatic acid及Talc)和水溶性滑動劑(Aerosil 200)之存在下,檢討Sodium starch glycolate (Primogel)、Croscarmellose sodium (Discolcel)、Crospovidone (Kollidone CL)及Partially pregelatinized starch (Starch 1500)之吸水行為(water-uptake behavior),結果顯示,這些潤滑劑和滑動劑對崩散劑的吸水行為有明顯的影響,但在加入膠原蛋白時,Stearic acid或Talc共存時,此等檢體之吸水行為受膠原蛋白影響較明顯,又當有疏水性有效成分(Ibuprofen)共存時,以Talc為潤滑劑者,其吸水行為受影響較明顯。
另一方面,曾有文獻藉熱示差掃描分析(DSC),指出Ibuprofen和Stearic acid之間存有互作用,而本研究顯示此種交互作用應不會因膠原蛋白的加入而改變。
Collagens, a glycol-protein, commonly exist in human body. The majority of collagens are present in the insoluble fibrous form and they play important physiologic roles in human body. In practical uses, the collagens are used as moisturizer because of their water up-take ability in nature.
Today, the tablet formulation still is one of major pharmaceutical dosage forms. Disintegration, it is primarily regulated by disintegrants, is an important process for achieving the therapeutic effect of solid dosage forms. Further, it is necessary to absorb water from environment to drive the disintegration action. On the other hand, a small amount of lubricants and gliants are consist in the dosage form make the manufacture process easier for tablet formulations.
Based on the literatures that the collagen has the characteristics of low immugenicity and water up-take ability, collagen can be a candidate as a choice of disintegration adjustor. In this study, we used the water-uptake behavior experiment in simulated gastrous liquid (0.1N HCl solution) as indicator to investigate the influence of collagen on the interaction among various disintegrants, lubricants and gliants composition as well as with or without the presence of hydrophobic active ingredient influences on the exoeriment formulation by means of siphon phenomena.
Experimentally, we used Magnesium stearate, Stearic acid and Talc as lubricant, Aerosil 200 as gliant and Ibuprofen as hydrophobic model drug to study water-uptake behaviors of Sodium starch glycolate (Primogel), Croscarmellose sodium (Discolcel), Crospovidone (Kollidone CL) and Partially pregelatinized starch (Starch 1500) which are common disintegrants. The result shown, the formulation only with lubricant and / or gliant, the water-uptake properties obviously were affected. But after addition of collagen, the water-uptake behaviors were not significantly influenced except the formulations using stearic acid and talc as lubricant. Additionally, in the presence of lubricant, glidant, the influence of collagen on the water-uptake properties was changed only when the talc was used as lubricant.
Furthermore, the literature shown that the Ibuprofen was interacted with stearic acid using Differential scanning Calometry (DSC). In this study, we shown that the addition of collagen was not change the above phenomena.
目錄
中文摘要……………………………………………………………………..I
英文摘要……………………………………………………………….…….II
誌謝…………………………………………………………………………….IV
目錄……………………………………………………………………………..V
表次目錄………………………………………………………………….......VIII
圖次目錄………………………………………………………………………..XI
本文
壹、緒論
一.研究動機………………………………………………………………1
二.文獻回顧與材料介紹…………………………………………………2
貳、研究目的……………………………………………………………….11
叁、材料與儀器
一.材料……………………………………………………………………12
二.儀器……………………………………………………………………13
肆、實驗方法
一、Collagem之萃取………..…………………………………………..14
二、黏度試驗……………………………………………………………..14
三、Collagem之定性試驗
1)Sodium dodecyl sulfate-polyacrylamide (SDS-PAGE)….................14
2)高速液相層析(High performance liquid chromatograph, HPLC)...17
四、吸水行為之測量
1)各種潤滑劑對不同崩散劑組成與吸水行為之測量……………...19
A.測量方法與吸水量之計算…………………………………….22
B.檢體之製備方法及處方表…………………………………..…22
2)含Collagem配方粉體之吸水行為測量………...…………………25
A.檢體之製備方法及處方表………………….…………………25
3)含Ibuprofen配方粉體之吸水行為測量……………………..…....34
A.檢體之製備方法及處方表…………………………………….34
五、熱示差掃描儀(Differential Scanning Calorimetry)……….………43
1)檢體之製備方法及處方表……………………………………...…43
伍、結果
一、Collagem之萃取…………………………………………..………44
二、萃取物之分析
1)電泳分析……………………………………...…………..……..…44
2)高速液相層析分析……………………………………………..….45
三、崩散劑吸水行為檢討
1)潤滑劑與滑動劑存在下之崩散劑吸水行為………………..…….46
2)潤滑劑、滑動劑與Collagem存在下之崩散劑吸水行為……….....47
3)潤滑劑、滑動劑、Collagem與Ibuprofen存在下之崩散劑吸水
行為……………………………………………………...………....50
4)膠原蛋白、Stearic acid、Aerosil 200存在時之Ibuprofen的示差熱掃描分析………………………………………………………....53
陸、討論
一、Collagem之萃取……………………………………………...….111
二、萃取物之分析
1)電泳分析………………………………………………………….111
2)高速液相層析分析…………………………………………...…..111
三、崩散劑吸水行為檢討………………………………………………111
1)滑劑劑與滑動劑存在下之崩散劑吸水行為………………...…..112
2)滑劑劑、滑動劑與Collagem存在下之崩散劑吸水行為……….114
3)潤滑劑、滑動劑、Collagem與Ibuprofen存在下之崩散劑吸水
行為………………………………………………...………….115
4) Collagem、Stearic acid、Aerosil 200存在時之Ibuprofen
的熱示差掃描分析………………………………………………..117
柒、結論……………………………………………………………………119
捌、參考文獻………………………………………………………………123
作者簡介…………………………………………………………………124
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