非傳統食用原料薑花捲葉萃取物之降血糖功能研究與安全評估

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Title:	非傳統食用原料薑花捲葉萃取物之降血糖功能研究與安全評估 Study of glycemia lowering effect and safety assessment of non-traditional raw material – Hedychium coronarium J. Koenig aqueous extraction
Authors:	謝玲珊 Tse, Ling-Shan
Contributors:	藥學系(碩博士班) 鄭幼文
Keywords:	野薑花;糖尿病;醛固酮;藥用植物;安全性 Hedychium coronarium;Type 2 diabetes;aldosterone;STZ;metabolic syndrome;herb;supplement safety assessment;Genotoxicity
Date:	2019-06-20
Issue Date:	2020-02-17 13:40:21 (UTC+8)
Abstract:	本論文主要在完成非傳統食品原料”野薑花”之安全性評估，以及探討其降血糖功能。在研究過程中，除了探究如何判定非傳統食品原料的定義與搜尋我國的管理規範之外，也逐步依法規完成此非傳統食材成為可供食用原料之前，所需執行之功效性以及安全性試驗，相當於小規模的生技產品研發實例。野薑花 ( Hedychium coronarium, HC)在不少的國家都有曾被使用在民族療法的記錄；而在台灣，野薑花的不單根莖及果實會被當作中藥使用，其嫩芽及花也會被當作野菜食用。野薑花本身種植容易，生長快速，是一個非常符合經濟效益的農作物，因此有一定的開發潛力。然而，縱使有不少關於野薑花的研究，但卻不屬於台灣可供食品原料之列，也未有足夠相關之毒性資料佐證其安全。依法規要求須執行原料(薑花捲葉水萃物)，以及其全產品之 (1) 基因毒性試驗、 (2) 28天及90 天餵食毒性試驗 (3) 致畸試驗。在原料 (HC) 之安全性試驗結果顯示HC 1.25mg/plate 於Ames test 會呈現陽性反應，於90天重覆餵食SD 大鼠後發現雄性大鼠血中鈉鉀、尿液量及心臟重量 (心臟淨重及心腦比)皆有顯著性變化，然而未有在臟器切片中發現與受試物相關之病變；此外，於致畸胎試驗發現HC高劑量 5 g/kg 可能干擾胎鼠骨骼鈣化之作用，但不會影響胎兒內臟發育，這些反應推測與其抗氧化特性及其可調降血中醛固酮(Aldosterone)之濃度效果有關。根據結果顯示，HC 28天餵食毒性試驗之無害作用劑量（NOAEL）可為5 g/kg，然而雌雄大鼠在90天餵食毒性試驗中反應有異，因此雌性大鼠之NOAEL可為5 g/kg，但雄性大鼠則建議訂在1.5 g/kg。另外致畸試驗之NOAEL會建議低於5 g/kg。糖尿病為全球第七大死因，也是台灣的第五大死因，是一個普遍的文明病。糖尿病分為4大族群，尤其第二型糖尿病(T2DM)佔最大比數。在本研究當中也針對野薑花原料 (HC)，以及含有薑花捲葉水萃物 7.2% 的健康食品“糖順心” (SugarOut, SO)之進行降血糖功效測定。在SO 和HC降血糖之研究當中，採用了Wistar 大鼠並給予streptozotocin (STZ) 65mg/kg 及 Nicotinamide 230 mg/kg 進行糖尿病誘導之第二型糖尿病(T2DM)動物模式進行實驗。實驗結果顯示，HC及SO 雖然未能調降空腹血糖值，但會增加血糖耐量、降低血中醛固酮、三酸甘油酯、膽固醇以及乳酸脫氫，並改善血中胰島素含量和胰臟受傷之程度。根據結果，HC及SO之人類有效劑量分別為0.72 mg/kg 及10mg/kg。此外，依法規也執行了SO 的健康食品第3類安全性評估試驗。SO之安全性試驗結果顯示，經過90天連續餵食SD大鼠後並不會造成生理影響，也不具基因毒性；同時不會影響胎兒內臟形成。根據結果顯示，不論SO 28天或90天餵食毒性試驗之無害作用劑量（NOAEL）可為2 g/kg；SO致畸試驗之NOAEL建議低於2 g/kg。我們結論，不論是野薑花捲葉水萃取物(HC)，或是含7.2 % HC之健康食品 (SO)皆可調節血糖功能，也分別為原料以及全產品訂出了28天、90天以及畸胎試驗的 NOAEL (無觀察到不良作用劑量)，這些毒性試驗資料可供HC 成為可供食品原料或SO申請健康食品之安全評估作參考。 To develop a novel food/ ingredient, the safety and efficacy must be determined. In this study, the definition and regulation of novel food/ ingredient had been explorated, followed by examination of safety and glycemia lowering effect of Hedychium coronarium (HC). Hedychium coronarium (HC) has been used in different countries as food and folk medicine. in tiawan, the rhizome and fruit of HC are used as folk medicine while flowers as vegetable. It is easy to plant and fast growing, hence it is a potential crop with an economical benefit. its pharmacological benefits have been studied, there is insufficient scientific evidence to verify the safety of HC. In this study, the underground part (leaves and stems) of HC was extracted and performed (1) genotoxicity, (2) Subacute (28days) and Subchronic (90days) oral administration toxicity study (3) teratogenic study. The studies showed that 1.25 mg/plate HC had positive response in Ames test, HC would not show effect on subacute toxicity study but would cause physiological changes. Those results might relate to its antioxidant properties and the characteristic of aldosterone regulation. Based on the results, the no observed adverse effect level (NOAEL) of Subacute (28days) toxicity study would be at 5 g/kg; Because substance-related effects were observed only in male rats but not in female rats, we propose 1.5 g/kg/day HC as the NOAEL for male rats. For female rats, the NOAEL was proposed to be 5.0 g/kg/day HC. The NOAEL of teratogenicity would be lower than 5 g/kg. Diabetes is the 7th leading cause of death worldwide and the 5th in Taiwan. There’s 4 type of Diabetes which type 2 takes the most population. In this study, the safety of a HC food supplement: SugarOut(SO) was tested. The studies showed that SO did not cause mutagenicity or clastogenicity in vitro or in vivo, also did not cause any effect of either Subacute (28days) and Subchronic (90days) oral administration toxicity study. Based on the results, both NOAEL in Subacute and subchronic toxicity study would be considered 2.0 g/kg/day (ADI=0.02g/kg/day). Furthermore, glycemia lowering effect of HC and SO was tested. In this study, chemical induced T2DM model was used, streptozotocin (STZ) 65mg/kg and Nicotinamide 230mg/kg was injected to wistar rats. HC and SO both didn’t lower the fast blood glucose level after 28days, but significantly increased glucose tolerance. After 28 days of treatment with HC and SO respectively, the levels of cholesterol, triglyceride, high-density lipoprotein, and low-density lipoprotein were significantly improved. The lesions degree of islet β-cells was decreased after treatment. Although the insulin level increased moderately, the aldosterone level was significantly decreased in the both treatment groups. Therefore, the effective dose (ED) of HC and SO would be 0.72 mg/kg 及10mg/kg. In this study, the NOAEL of Subacute (28days) and Subchronic (90days) oral administration toxicity study, teratogenicity, and efficacy of both HC extract and SO (a HC based (7.2%) health food) have be difined. Hopefully this research can be a reference for novel food developing in the future.
Description:	博士指導教授：鄭幼文委員：王靜瓊委員：顧記華委員：黃聰龍委員：李美賢
Data Type:	thesis
Appears in Collections:	[藥學系] 博碩士論文

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