TWI380823B - 脂聯素（Ａｄｉｐｏｎｅｃｔｉｎ）濃度上升劑 - Google Patents
脂聯素（Ａｄｉｐｏｎｅｃｔｉｎ）濃度上升劑 Download PDFInfo
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- TWI380823B TWI380823B TW095125385A TW95125385A TWI380823B TW I380823 B TWI380823 B TW I380823B TW 095125385 A TW095125385 A TW 095125385A TW 95125385 A TW95125385 A TW 95125385A TW I380823 B TWI380823 B TW I380823B
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- adiponectin
- guava leaf
- concentration
- drinking
- leaf extract
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Description
本發明係關於一種以番石榴葉萃取物為有效成分之脂聯素濃度上升劑。
自古以來，已知悉番石榴葉萃取物對糖尿病、高血壓、便秘、肥胖、下痢等具有療效，直接或者進行適當加工後可用作健康維持飲料。番石榴(Psidium guajava Linn.)係一種自然生長於熱帶、亞熱帶地區之桃金娘科番石榴屬之常綠樹，其葉如上所述可作為維持健康飲料等，又，其果實除生食外可以果汁形式被利用等。
近年來，番石榴葉萃取物之藥理作用受到人們的關注，目前已提出有如下各種作用或用途：具有抑制α-澱粉酶作用之減肥食品(專利文獻1)、病毒感染預防及治療劑(專利文獻2)、過氧化脂質生成抑制劑(專利文獻3)、腎臟疾病之預防治療劑(專利文獻4)、糖化作用抑制劑(專利文獻5)、脂肪酶抑制劑(專利文獻6)。
另一方面，由於近年來分子生物學之進展，與人類疾病有關之各種因子正被闡明。其中，現已明確脂肪組織特異性激素因子即脂聯素具有增強胰島素敏感性之作用、抗動脈硬化作用等；「低脂聯素血症」係處於糖尿病、動脈硬化症等發病之上游之根本病態(非專利文獻1)。再者，已報告有脂聯素具有治療及預防各種癌、心臟肥大、腸息肉、感染症、纖維症及發炎性疾病之作用(專利文獻7)，治療急
性創傷之作用(專利文獻8)，預防及改善高血壓病之作用(專利文獻9)，預防及治療肝硬化或慢性肝炎之作用(專利文獻10)；因而現已明確脂聯素不僅可糾正糖或脂質之代謝異常，而且與各種疾病有關。
因此，就治療或改善或者預防該等各種疾病之觀點而言，提昇血中之脂聯素濃度或者抑制其降低係非常之重要，因而業者期望具有提昇血中之脂聯素濃度之作用，且可長期攝取及安全性較高之物質。
然而，現狀為具有提昇血中脂聯素濃度之作用之組合物，僅報告有發酵茶萃取物(專利文獻11)，可選擇餘地非常小。又，迄今為止並無番石榴葉萃取物可提昇血中脂聯素濃度之報告。
[專利文獻1]日本專利第2670742號公報
[專利文獻2]日本專利特開2000-273048號公報
[專利文獻3]日本專利特開平11-75770號公報
[專利文獻4]日本專利第3625900號公報
[專利文獻5]日本專利特開2004-250445號公報
[專利文獻6]日本專利特開2000-103741號公報
[專利文獻7]日本專利特開2004-345968號公報
[專利文獻8]日本專利特開2004-331590號公報
[專利文獻9]日本專利特開2004-275041號公報
[專利文獻10]日本專利特開2002-363094號公報
[專利文獻11]日本專利特開2004-315379號公報
[非專利文獻1]Molecular Medicine，Vol.39，No.4，第
416-423頁(2002)
因此，本發明之目的在於提供一種醫藥、飲食品，其具有提昇血中脂聯素濃度之作用且可長期攝取、安全性較高。
本發明者們為解決上述問題而進行精心研究之結果是，發現番石榴葉萃取物具有提昇血中脂聯素濃度之作用，而且即使日常性攝取該番石榴葉萃取物亦不會產生副作用，從而完成本發明。
即，本發明係提供一種以番石榴葉萃取物為有效成分之脂聯素濃度上升劑。
又，本發明係提供一種提昇脂聯素濃度之方法，其特徵在於：以有效量投予番石榴葉萃取物。
進而，本發明係提供一種用以製造脂聯素濃度上升劑之番石榴葉萃取物之用途者。
番石榴葉萃取物表現有優異之脂聯素上升作用，又，該萃取物自古以來就用作健康維持飲料等，食用經驗亦較為豐富，故而係安全性較高者。因此，本發明之脂聯素濃度上升劑，可廣泛應用於與脂聯素有關之糖尿病、動脈硬化症、各種癌、心臟肥大、腸息肉、感染症、纖維症、發炎性疾病、急性創傷、高血壓症、肝硬化及慢性肝炎等各種疾病之治療或改善或者其預防等目的，且副作用較少及安
全。
本發明中所使用之番石榴葉為番石榴(Psidium guajava Linn.)(別名：芭樂)之葉。本發明中所使用之番石榴葉萃取物，可藉由以水及/或親水性有機溶劑萃取番石榴葉而獲得。番石榴葉萃取物因較葉本身具有更強之脂聯素上升作用，嗜好性亦優良，故為較好。
萃取中所使用之番石榴葉，既可為新鮮狀態者，亦可為經乾燥者，可使用將該等切斷成適當大小例如3 mm~5 mm者。又，亦可使用經乾燥後焙煎者，該情形就改善風味方面而言為較好。
至於萃取中所使用之溶劑，可列舉：水，甲醇、乙醇、丙醇、丁醇等低級醇，乙酸乙酯等酯，乙二醇、丁二醇、丙二醇、1,3-丁二醇、丙三醇等醇類，二乙醚、石油醚等醚類，丙酮、乙酸等親水性溶劑，苯、己烷、二甲苯等烴等；較好的是水及/或親水性溶劑。該等溶劑既可單獨使用，亦可將兩種以上組合使用。
萃取時植物與溶劑之比率，較好的是相對於植物乾燥重量，溶劑為1~100重量倍，尤其好的是2~40重量倍。
至於萃取方法，可使用一般性方法，例如可列舉：於溶劑中浸漬番石榴葉之方法、於加溫下(常溫~溶劑沸點之範圍)進行攪拌之方法等，亦可使用壓力式萃取釜等進行萃取。
萃取條件，因原料狀態及所使用溶劑之種類而不同，例
如可列舉：於常壓至加壓條件下，即1大氣壓~2大氣壓之範圍內，於室溫下進行或者將其加溫/加熱；於熱水萃取之情形時，可列舉：於50~130℃之加熱條件下，萃取1分鐘至2小時之例。若藉由上述萃取方法，則亦可對有可能存在於原料番石榴葉中之雜菌例如耐熱芽孢菌等進行滅菌處理，因而無須擔心雜菌污染，亦就衛生之觀點而言安全性極高，故而較好。
又，既可於萃取溶劑中添加碳酸氫鈉水溶液等鹼使pH值升高後進行萃取，亦可添加稀無機酸(例如稀鹽酸)或者有機酸(例如：琥珀酸、檸檬酸、乳酸、蘋果酸、酒石酸)製成弱酸性後再進行萃取。
於本發明中，番石榴葉萃取物，可直接使用以如此方式獲得之萃取物，亦可使用於萃取後藉由常法將萃取液進行分離，且根據需要除去雜質後所獲得者。又，既可使用一旦使用真空濃縮機等進行濃縮且將萃取溶液除去者，亦可採用冷凍乾燥法將其粉末化者。
又，亦可使用將以上述方式獲得之萃取物進而施加適當之層析法處理等純化處理等進行純化者，關於該萃取物之純化程度及利用形態等並無特別限制。
該等番石榴葉萃取物，亦可將萃取方法等不同之2種以上之萃取物混合使用。
如此所獲得之番石榴葉萃取物，含有高濃度之來源於番石榴葉中所含有之天然物質之有效成分，其作用機理並不明確，但若投予生物體內，則具有提昇血中、臟器、組
織、或細胞等中之脂聯素濃度之作用，故而可用作脂聯素濃度上升劑，尤其可用作血中脂聯素濃度上升劑。繼而，以上述萃取物為有效成分之脂聯素濃度上升劑，可應用於與脂聯素有關之糖尿病、動脈硬化症、各種癌、心臟肥大、腸息肉、感染症、纖維症、發炎性疾病、急性創傷、高血壓症、肝硬化及慢性肝炎等各種疾病之治療或改善或者預防等目的。又，本發明之脂聯素濃度上升劑，亦可用於重複具有糖尿病、高血壓症、高脂血症等且產生心肌梗塞或腦梗塞等危險性較高之狀態即新陳代謝症候群(Metabolic syndrome)(代謝異常症候群、多危險因素症候群(Multiple risk factor syndrome)、內臟脂肪蓄積症候群)之預防及改善等目的。
本發明之脂聯素濃度上升劑之投予方法，亦可使用經口投予或者非經口投予之任一種方法，但較好的是經口投予。投予時，可將有效成分與適於經口投予、直腸內投予、注射等投予方法之固體或液體之醫藥用無毒性載體混合，而以慣用之醫藥品製劑形態進行投予。
至於如此之製劑，例如可列舉：錠劑、顆粒劑、散劑、膠囊等固體劑，溶液劑、懸濁劑、乳劑等液劑，冷凍乾燥劑等。該等製劑可藉由製劑上之常規方法製備。至於上述醫藥用無毒性載體，例如可列舉：葡萄糖、乳糖、蔗糖、澱粉、甘露糖醇、糊精、脂肪酸甘油酯、聚乙二醇、羥乙基澱粉、乙二醇、聚氧乙烯山梨糖醇酐脂肪酸酯、胺基酸、明膠、白蛋白、水、生理鹽水等。又，亦可根據需要
適當添加穩定劑、濕潤劑、乳化劑、黏合劑、等張劑、賦形劑等慣用之添加劑。
又，本發明之脂聯素濃度上升劑，不僅可用作如上述之醫藥品製劑，而且亦可用作飲食品等。於此情形時，將上述番石榴葉萃取物直接或添加各種營養成分而使之含於飲食品中，可用以提昇脂聯素濃度之目的或用作對與脂聯素有關之糖尿病、動脈硬化症、各種癌、心臟肥大、腸息肉、感染症、纖維症、發炎性疾病、急性創傷、高血壓症、肝硬化及慢性肝炎等疾病之治療或改善等有用之保健用食品或者食品原材料。例如，亦可於上述番石榴葉萃取物中添加可用作飲食品之添加劑後，採用慣用方法成形為適於食用之形態，例如顆粒狀、粒狀、錠劑、膠囊、糊狀物(Paste)等以供食用，又，亦可添加於各種食品例如火腿、臘腸等食肉加工食品，魚糕、魚卷等水產加工食品，麵包、點心、奶油、乳粉、發酵乳製品中使用，或者添加於水、果汁、牛乳、清涼飲料等飲料中使用。
再者，作為飲食品，可適宜使用直接採用番石榴葉萃取物之番石榴葉茶飲料。於製造該番石榴葉茶飲料之情形時，較好的是使用例如：將番石榴葉進行乾燥，於約120℃下焙煎10~20分鐘後，切碎成3~5 mm，以50~100℃水萃取1~60分鐘，較好的是3~25分鐘，將所得之番石榴葉萃取物以適當濃度，較好的是以丹寧酸的含量成為0.05~0.1%左右之方式，進行濃縮或稀釋而製備之番石榴葉萃取物。
本發明之脂聯素濃度上升劑之有效成分即番石榴葉萃取物，先前係用作食品，其安全性亦已被確認，故而將其用作脂聯素濃度上升劑之情形之投予量並無嚴格限制，但其合適之投予量，較好的是作為乾燥固形分，為每天150 mg~2g，尤其好的是400 mg~1.6g。
以下，藉由製造例、試驗例、實施例就本發明之內容加以更詳細之說明，但本發明並非限制於該等者。
將番石榴葉(產於中國)加以乾燥，於121℃下焙煎15分鐘後，切碎成5 mm左右。將75 kg該茶葉加入1500 kg之95℃熱水中萃取5分鐘。將萃取液冷卻至30℃以下，進行離心分離使之澄清化後，加水稀釋使丹甯酸量成為0.06~0.07重量%，獲得番石榴葉萃取物。於該萃取物中添加0.05重量%抗壞血酸鈉，製造番石榴葉茶飲料。
添加2 L水於100 g乾燥番石榴葉中，於80℃下加熱萃取30分鐘，以4層紗布進行過濾，將所獲得之番石榴葉萃取物進行冷凍乾燥處理，製成粉末。產量為約14%。
於500 mL之50%含水乙醇中，將25 g乾燥番石榴葉於常壓及室溫下萃取1週。將所獲得之番石榴葉萃取物以紗布進行過濾後，將濾液進行減壓乾燥固化而製成粉末。產量約為30%。
使用製造例1之番石榴葉茶飲料，研究其對於血中脂聯素濃度所帶來的影響。給23名(15名女性，8名男性)含有試驗前之總膽固醇值為180 mg/dL以上之邊緣區域之輕度高血脂症者飲用8週製造例1之番石榴葉茶飲料，1天3次，1次200 mL。於飲用開始前及飲用第4、8週，進行血液生化學檢查、尿檢查、診斷等，又，於飲用開始飲用後第1週、第4~5週及飲用結束前1週，對飲食內容進行問卷調查。
再者，給對象者中之7名處方給要作為抗高血脂藥之氟伐他汀鈉(Lochol)、普伐他汀(Mevalotin，HMG-CoA還原酶抑制劑))、匹伐他汀(Pitavastatin，高膽固醇血症治療藥)、Cholebine(膽固醇吸收抑制劑)、廿六烷五烯酸乙酯(Epadel，降甘油三酸脂(Triglycerides)藥)，但在番石榴葉茶飲料飲用期間並未改變藥物之種類或數量。
將對象者飲用開始前及飲用第8週之血中脂聯素濃度分為小於4 μg/mL、4 μg/mL以上且小於7 μg/mL、7 μg/mL以上之3組，且示於表1。
如表1所示，飲用第8週時，可發現向更高血中脂聯素濃
度組轉移，在整體上血中脂聯素濃度増加，尤其是在15名女性中增加至9名。又，對象者全體之血中脂聯素濃度之平均值，自飲用前之8.6 μg/mL增加至飲用第8週之8.9 μg/mL。
其次，飲用開始前之體脂肪率為肥胖區域(女性：30%以上，男性：25%以上)者於飲用開始前、飲用第4週及飲用第8週之血中脂聯素濃度，示於表2。飲用開始前之HbA1c(糖化血色素)為糖尿病區域(6.5%以上)者之結果，亦示於表2。
如表2所示，飲用開始前之體脂肪率為肥胖區域之對象者之脂聯素濃度，於飲用第8週増加。又，飲用開始前之HbA1c(糖化血色素)為糖尿病區域之對象者之脂聯素濃度，亦於飲用第8週増加。
此外，獲得以下結果。
1.研究血中膽固醇值之結果為，在女性中，飲用第8週血中總膽固醇值呈下降趨勢(p=0.07)，且LDL-膽固醇值呈下降趨勢(p=0.05)。另一方面，HDL-膽固醇值無變化。
2.於飲用開始前之總膽固醇值為220 mg/dL以上之高值者
中，可見飲用第4週總膽固醇值之下降趨勢(p=0.06)，於第8週可見顯著下降(p<0.05)。又，LDL-膽固醇值亦呈下降趨勢(p=0.06)，該結果在女性中表現顯著。
3.於飲用第8週HbA1c值顯著下降(p<0.05)。
4.其它血液檢查值或尿檢查值中未見異常值或較大波動。又，並無下痢或便秘、食欲不振、不適感等不良現象，於飲用期間飲食內容未見大的變動。
根據以上結果，可知將番石榴葉萃取物給人飲用可提高血中之脂聯素濃度。飲用中飲食內容並無大的變動，又，並不改變原先開處方之藥物之種類或數量，故而一般認為血中脂聯素濃度上升作用係起因於飲用番石榴葉萃取物。
再者，因於飲用期間並未產生不良現象，未見血液檢查值或尿檢查值中之異常值，故而可確認其安全性。現揭示有，尤其是若脂聯素在人血中之濃度為4 μg/mL以下，則冠狀動脈疾病之危險率上升(Bio Clinica，19，第18-30頁，2004)。於此次試驗中，於飲用第8週，脂聯素濃度小於4 μg/mL者減少，對象者全體之血中脂聯素濃度之平均值増加，由此可知飲用番石榴葉萃取物對生物體而言具有意義。再者，於飲用開始前體脂肪率為肥胖區域之對象者或HbA1c為糖尿病區域之對象者中，血中脂聯素濃度増加，由此揭示飲用番石榴葉萃取物尤其是對預防及改善代謝綜合症有效。
按下述處方將各種成分混合進行造粒、乾燥、整粒，之
後打錠而製造錠劑。
按下述處方根據常法添加各成分，且將其勻質化而獲得清涼飲料。將所獲得之清涼飲料填充於褐色瓶中，之後以鋁蓋進行密封，且實施加熱處理。
於15%脫脂乳中添加3%葡萄糖，於120℃下進行3秒之殺菌，之後接種1%酪蛋白乳酸桿菌(Lactobacillus casei)YIT9029株之菌種，於37℃下培養至pH 3.6，獲得210 g酸乳基質。另一方面，將97 g砂糖、0.2 g檸檬酸鐵及5 g製造例2之萃取物溶解於水，且添加水將總量調整為790 g，將該溶液於110℃下進行3秒殺菌，獲得糖漿。將以
上述方式獲得之酸乳基質與糖漿混合且添加1 g香料，之後於15 Mpa下將其勻質化後再填充於容器中而獲得發酵乳製品。
Claims (2)
- 一種脂聯素濃度上升劑，其係以藉由水及/或親水性溶劑進行萃取所得之番石榴葉萃取物作為有效成分。
- 一種藉由水及/或親水性溶劑進行萃取所得之番石榴葉萃取物之用途，其係用以製造脂聯素濃度上升劑。
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| JP2010105922A (ja) * | 2008-10-28 | 2010-05-13 | Uha Mikakuto Co Ltd | Ｌｏｘ−１アンタゴニスト作用剤 |
| WO2011083586A1 (ja) * | 2010-01-07 | 2011-07-14 | 株式会社 エコビジネス | グァバ葉抽出ポリフェノール成分エキスを含んだ乳製品の組み合わせ食材 |
| JP2011231078A (ja) * | 2010-04-30 | 2011-11-17 | Nagaoka Koryo Kk | 非アルコール性脂肪性肝疾患の予防および／または治療に有効な経口摂取用組成物 |
| JP2012050335A (ja) * | 2010-08-31 | 2012-03-15 | Ken Ganaha | グァバ茶葉の製造方法 |
| CN104415187A (zh) * | 2013-09-02 | 2015-03-18 | 张培轩 | 一种用纯中药降低高血脂的药品 |
| CN104189075A (zh) * | 2014-09-25 | 2014-12-10 | 胡向荣 | 一种用于治疗慢性乙肝的中药 |
| CN104474014A (zh) * | 2014-10-22 | 2015-04-01 | 赵常萍 | 用于疏通心脑血管的中药组合物 |
| CN104491242B (zh) * | 2014-11-27 | 2018-10-23 | 宇特金 | 一种治疗认知功能障碍的药物组合物及其制备方法和用途 |
| CN104606404A (zh) * | 2015-02-06 | 2015-05-13 | 苏州市天灵中药饮片有限公司 | 一种治疗高血脂的中药组合物及其制备方法 |
| CN104784371A (zh) * | 2015-04-30 | 2015-07-22 | 陈大忠 | 一种抗酒精性肝损伤的药物组合物及其制备方法 |
| CN107375483B (zh) * | 2017-08-01 | 2018-03-23 | 孙维伯 | 一种降血脂口服组合物及其制备方法 |
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| JP5597345B2 (ja) | 2014-10-01 |
| EP1902722B1 (en) | 2020-12-16 |
| EP1902722A1 (en) | 2008-03-26 |
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