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標題: Development of a slow release vitamin B-enriched food supplement
作者: Chiu-Pei Li
關鍵字: 維生素B;緩釋錠;vitamin B;slow release tablet
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本實驗擬將一般錠劑的維生素B群保健食品,開發成可緩釋的保健食品,目的使B群活性成分於體內緩慢釋出,可持續補充維生素B群。實驗設計為使用羥丙基甲基纖維素(hydroxypropyl methyl cellulose , HPMC 2208)及海藻酸鈉(包括:MANUCOL® LKX、PROTANAL® 8233和KIMICA ALGIN),設計8個緩釋錠配方進行試製並建立緩釋錠關鍵製程管制點,確認直打法可適用於本研究B群緩釋錠的開發。在素錠的溶離速率的實驗中發現海藻酸鈉系列緩釋劑可當作本實驗之緩釋劑,且以添加海藻酸鈉(KIMICA ALGIN 15%)之配方,較符合實驗設計緩釋之效果。接著,利用光照試驗及50 ± 2°C / 75 ± 5% RH加速虐待試驗後,確認膜衣增重4%為最佳配方,確認未來市售應以塑膠瓶為最佳包材,鋁箔袋次之,較能確保產品品質。成品經加速安性試驗3個月,檢驗主成分維生素B1、維生素B2及維生素B6,含量皆符合規格標準,於80%至120%之合格範圍內,顯示此配方其品質安定性穩定。

This study was to develop a slow release vitamin B complex table. The purpose was to make the vitamin B complex slowly releasing in our body to give a better absorption vitamins, hydroxypropyl methyl cellulose (HPMC 2208) and sodium alginate (including MANUCOL® LKX, PROTANAL® 8233, and KIMICA ALGIN) were used and eight slow release formulas of B complex tablets for trial production were designed in this study. After the trial production, some key process control points of the targeted slow release tablet production were established. It was confirmed that the direct compression method could be applied in the development of B complex slow release tablets. By comparing the dissolution rate of an uncoated tablet, it was found that sodium alginate could be used as a slow release agent. The formulation with 15% of sodium alginate (KIMICA ALGIN) gave a better slow release performance. After the photostability and stress studies (50°C ±2°C / 75% RH ± 5% RH), the formula with is 4% in the film weight gain was suggested for the film-coated tablet. The best option was of packaging materials in the commercial product was plastic bottle and the second was aluminum bags to ensure the product quality. After a three months of accelerated stability study, the contents of activity ingredients including vitamin B1, B2, and B6, in the finished product were all between 80% and 120% and met the specifications. The results showed that the formula was stable in terms of quality and could be used for scale-up production.
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