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研究生:翁嘉琳
研究生(外文):chia-ling weng
論文名稱:賦型劑對不同水溶性維生素B混合物溶離及安定性之影響
論文名稱(外文):Effects of excipients on dissolution and stability of soluble vitamin B complex
指導教授:黃登福黃登福引用關係
指導教授(外文):Deng-Fwu Hwang
學位類別:碩士
校院名稱:國立海洋大學
系所名稱:食品科學系碩士在職專班
學門:農業科學學門
學類:食品科學類
論文種類:學術論文
論文出版年:2003
畢業學年度:91
語文別:中文
論文頁數:142
中文關鍵詞:維生素B賦型劑安定溶離
外文關鍵詞:Vitamin BExcipientStabilityDissolution
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由於近年來國人食用維生素與礦物質等保健食品有顯著上升的趨勢,因此,本實驗乃針對市面上所販售之維生素B群為主的營養補充劑進行檢測。
首先為建立HPLC分析維生素B混合物之檢測法,乃使用ODS C18層析管 ( 25 X 4.6 mm ) 分析。其中,藉由增加移動相中甲醇的比例,可獲得較適當之條件,並得知移動相之組成為水 / 甲醇 / 冰醋酸為 62 / 38 / 1。其次pH會影響其溶出時間,經檢測以pH 3.0最為適當。此HPLC方法之專一性、精密度、準確度、線性及回收率等,均經實驗證實具有良好之效應。
另外,製備維生素B混合物膠囊,並添加5% 不同的賦型劑Chitosan、Collagen和Ascorbic acid等,與一般的賦型劑進行崩散試驗,經比較其溶解情形,結果得知並無顯著差異。另外,進行溶離試驗以確認主成分之溶出情形,藉以推測營養補充劑經人體服用後之溶解情況。結果發現添加5% Chitosan作為賦型劑者其主成分溶出效果較添加5% Ascorbic acid及傳統賦型劑 Potato starch者差,其中以Thiamine HCl 影響較大,顯示添加5% Chitosan會影響維生素B混合物的主成分釋出率。由結果推測,Chitosan不適合添加於維生素B混合物中作為賦型劑。另外,添加5% Ascorbic acid於初期部分主成分釋出情形有微幅上升趨勢,但經儲存9個月後則無顯著差異。
不同劑型在不同儲藏條件下之維生素B群的安定性,經檢測後得知以室溫儲藏8個月維生素B群之產品,其維生素含量顯著下降,其中尤其以Thiamine HCl下降最為明顯,其安定性情形為:糖衣錠>錠劑>膠囊。控制儲藏溫度於20-25℃時,其安定性情形亦優於室溫儲存者。另外,置於55℃存放者,其安定情形則以錠劑>糖衣錠>膠囊。
添加5% Ascorbic acid作為賦型劑之維生素B複合劑膠囊,經儲存8個月後Thiamine HCl較對照組有顯著下降的情形,而添加5% Chitosan及5% Collagen者,Thiamine HCl含量急速下降,而Riboflavin、
Nicotinamide及Pyridoxine HCl之安定性程度則以添加5% 之Ascorbic acid>Chitosan>Collagen。
其次,採購和檢測市售維生素B群之產品,經比較標示值和實際檢測值後,發現部分市售之標示值不符合實際測定值。其中尤以食品級之兩件檢體,各項維生素B成分均偏低或甚至缺乏,而市售藥品級維生素B群產品之標示尚可信,顯示食品級者須加以管制。
According to survey, nutrition supplement (such as vitamin and mineral) consumption in Taiwan is rising. Our experiments targeted vitamin B complex. First, we tried to build a method using HPLC with ODS C18 (25 X 4.6 mm) to analyze vitamin B. The best conposition of mobile phase was as follows : water / methanol / glacial acetic acid = 40 / 60 / 1. Second, the pH value affected the retention time of vitamin B. We have found pH 3.0 was the best. The determination method was proved to be specificity, accuracy, linearacy, and good recovery.
The vitamin B complex capsule was added 5% excipient such as chitosan, collagen, and ascorbic acid. It was found to be no significant difference for dissolution test. On the other hand, the dissolved main component in the capsule was also determined. We found the dissolution of nutrient from the vitamin B capsule with adding 5% chitosan excipient was worse than that of the vitamin B capsule with adding 5% ascorbic acid excipient or potato starch excipient, especially for thiamine HCl. It indicated that chitosan who not suitable for excipient in vitamin B complex capsule.
Different vitamin B product requires different storage condition to keep its stability. From experiment we found the component of vitamin B product was reduced significantly, especially for thiamine HCl. Among different packags, sugar coated tablet showed the best stability, followed by tablet and capsule, when stored at 20-25℃ range.
The vitamin B capsule with adding 5% ascorbic acid as excipient was stored for eight months, thiamine HCl level was reduced significantly. In addition, the vitamin B component in the capsules with adding 5% chitosan and 5% collagen were reduced rapidly. Components such as riboflavin, nicotinamide and pyridoxine HCl increased the stability by adding 5% with ascorbic acid, followed by collagen and chitosan.
Finally, the commercial vitamin B products collected from the markets were determined. It was found that 2 samples of food grade vitamin were particularly low for all vitamin B components or even lack. The medical grade vitamin B products were more credible on its label.
目 錄
頁次
中文摘要………………………………………………………… 1
英文摘要……………………………………………………………… 3
第一章 文獻整理………………………………………………………5
一、維生素營養補充劑的背景、銷售及相關法規…………………6
二、維生素B群的特性、功能及劑量………………………………11
三、藥品的安定性試驗……………………………………………20
四、影響藥品安定性的因素………………………………………26
五、高分子天然聚合物或抗氧化劑作為藥品載體………………29
1. 幾丁質與幾丁聚醣…………………………………………30
2. 膠原蛋白……………………………………………………38
3. 維生素C ……………………………………………………42
六、維生素B群的檢驗分析…………………………………………42
七、崩散及溶離試驗………………………………………..46
八、圖表…………………………………………………………50
第二章、分析方法驗證及市售樣品檢測…………………………..59
一、前言………………………………………………………………60
二、材料與方法……………………………………………………….62
三、結果……………………………………………………………69
四、討論……………………………………………………………..72
五、圖表………………………………………………………………74
第三章 、安定性試驗…………………………………………………89
一、前言………………………………………………………………90
二、材料與方法……………………………………………………….93
三、結果……………………………………………………………96
四、討論……………………………………………………………..99
五、圖表………………………………………………………………104
第四章、溶離及崩散試驗………………………………………….…….111
一、前言………………………………………………………………112
二、材料與方法……………………………………………………….113
三、結果……………………………………………………………115
四、討論……………………………………………………………..118
五、圖表………………………………………………………………120
總結………………………………………………………………………………..125
參考文獻………………………………………………………………..128
誌謝…………………………………………………………………………139
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