臺灣博碩士論文加值系統

糖尿病為國人主要的慢性疾病之一，然而在中醫藥的產業中卻缺乏有效的植物藥給中醫做糖尿病的治療使用。有鑑於此，本論文透過一連串的研究與資源整合，找出一項有依據且可以協助控制血糖的植物：「武靴葉」。

武靴葉 (gymnema sylvestre) 為印度傳統草藥，可使味覺對甜味麻痺，常用於糖尿病治療。研究指出武靴葉之有效成分為武靴葉酸 ( gymnemic acid )，其結構上接有糖基，可透過結合葡萄糖受器達到抑制糖質吸收之作用。目前已有武靴葉之科學中藥產品，但其中武靴葉酸濃度受限於傳統製程，無法有效提高，應用上受到阻礙。本研究嘗試以各種特殊溶劑對武靴葉內之武靴葉酸進行專一性提取，在提高萃取物中武靴葉酸濃度之前提下，增加回收率，期望開發具有商業應用價值之武靴葉酸萃取製程。除此之外，本研究以超高效液相層析儀為分析儀器，針對武靴葉酸開發出一個快速的檢測方法，且完成方法確效，並將此檢驗方法用在最終產品的品質管控上。

由結果可知，本研究開發之武靴葉製程具有良好之回收率，可直接應用於大量製程，具有經濟效應。本研究有系統地建立武靴葉活性成分萃取方法及產品活性成分品質的控管。在分析方法確效部分，參照「國際醫藥法規協和組織（international conference on harmonization, ICH）規範」，檢量線性範圍介於1-300 µg/mL，且線性關係R2為0.99981 ; LOD為0.25 µg/mL、LOQ為1 µg/mL ; 回收率介於85~110% ; 日內變異係數低於10%、日間變異係數低於14%。

未來可將該植物萃取物成功地製成產品銷售至市場，並讓中醫師做使用 ; 如此，除了滿足中醫師的醫療資源缺乏外，更能提供學術上之參考價值。

Diabetes is one of the major chronic diseases in our nation. However, there is a shortage of effective botanicals for the treatment of diabetes in the traditional Chinese medicine industry. Here, using research and resource integration, we aimed to identify a plant that can improve glycemic control in an evidence-based manner.

Gymnema sylvestre is a traditional Indian herb that helps reduce cravings for sweets; it is commonly used in treating diabetes. Modern studies have shown that the active ingredient of gymnema sylvestre is gymnemic acid, which contains a glycosyl group in its structure; gymnemic acid inhibits glucose absorption by binding to glucose receptors. Currently, several products of gymnema sylvestre are available; however, owing to constraints imposed by traditional processing methods, it has been difficult to efficiently raise the concentration of gymnemic acid, thereby hindering its applications. Here, we tried to extract gymnemic acid from gymnema sylvestre using various special solvents and to increase its recycling rate under the premise of raising the concentration of gymnemic acid in the extract, with the expectation of developing an extractive process of gymnemic acid with commercial value. In addition, this study also aimed to develop a rapid method by ultra-high performance liquid chromatography (UHPLC) for identifying gymnemic acid; the developed method was effective and used in quality control of the final product.

The results indicate that the processing developed in this study has a good recovery rate and can be directly applied for production, thereby generating economic benefits. This study has systematically established the method of extracting gymnemic acid and controlling its activity. Validation of the UHPLC method was carried out according to International Conference on Harmonization (ICH) Q2 (R1) guidelines. Linearity was observed in the range of 1 – 300 µg/mL with correlation coefficient of 0.99981. LOD is 0.25 µg/mL and LOQ is 1 µg/mL. Recoveries ranged between 85 ~ 110%. The Intra-day and Inter-day CVs were mostly below 10% and 14%.

In the future, the plant extraction can be successfully developed into products for sale and can be used by Chinese medicine practitioners. Thus, apart from satisfying the shortage of medical resources in the Chinese medicine industry, the products can also serve as valuable in academic reference.

目次
中文摘要
英文摘要
目錄
第一章、緒論
1.1研究背景
1.1.1糖尿病的介紹
1.2研究動機
1.2.1西藥治療簡介與藥物市場概況
1.2.2治療糖尿病西藥常見的副作用
1.2.3治療糖尿病之中醫用藥及天然植物藥功效性評估
1.2.4藥品法規問題
1.3武靴葉的簡介
1.4分析方法確效法規規範
第二章、實驗材料及方法
2.1實驗架構
2.2實驗材料
2.2.1實驗室萃取
2.2.2大量製程萃取
2.3實驗方法
2.3.1實驗室萃取
2.3.2武靴葉大量試製
2.4分析方法之確效
2.4.1儀器設備
2.4.2材料與試劑
2.4.3檢品前處理方法
2.4.4超高效液相層析分析方法
2.4.5檢量線配置、線性範圍、偵測極限與定量極限
2.4.6方法回收率之評估
2.4.7日內變異與日間變異
第三章、結果與討論
3.1去除干擾物質及萃取溶劑選擇評估
3.2萃取溫度評估
3.3萃取溶劑濃度評估
3.4武靴葉萃取物試製
3.5分析方法確效結果
3.5.1檢量線配置、線性範圍、偵測極限與定量極限
3.5.2方法回收率之評估
3.5.3日內變異與日間變異
第四章、結論
第五章、參考文獻

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