TWI819039B - 含有藤茶萃取物的組成物、錠劑及膠囊劑 - Google Patents
含有藤茶萃取物的組成物、錠劑及膠囊劑 Download PDFInfo
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- TWI819039B TWI819039B TW108126159A TW108126159A TWI819039B TW I819039 B TWI819039 B TW I819039B TW 108126159 A TW108126159 A TW 108126159A TW 108126159 A TW108126159 A TW 108126159A TW I819039 B TWI819039 B TW I819039B
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Abstract
本發明係提供一種大量含有藤茶萃取物,且抑制了藤茶特有的異味(被評價為惡臭的臭味)的組成物及錠劑或膠囊劑。
本發明係將組成物調備並製成錠劑或膠囊劑者,該組成物含有殼聚糖及藤茶萃取物的,每份組成物含有10至35質量%的殼聚糖、5至22質量%的白蘞素,且殼聚糖/白蘞素的質量比為0.6至3.5。
Description
本發明係有關一種抑制了藤茶萃取物的臭味的組成物及含有該組成物的錠劑或膠囊劑。
藤茶為葡萄科蛇葡萄屬的植物,中國名為顯齒蛇葡萄。學名為Ampelopsis grossedentata。主要分佈於中國的廣西、廣東、雲南、貴州、湖南、湖北、江西及福建等省及自治區。中國的廣西、湖南等省或自治區的壯族或瑤族的人們經常飲用由其莖及葉製成的飲料,還用於感冒、咽喉痛等。
對於藤茶萃取物已發現有各種各樣的生理活性,已提案有含有藤茶萃取物的醫藥用途或健康食品用途。例如已提案有肝臟疾病的治療用(專利文獻1)、脂肪酶阻礙用(專利文獻2)、基質蛋白酶阻礙用(專利文獻3)、抗菌用(專利文獻4)、防止香料的劣化用(專利文獻5)及防止色素的褪色用(專利文獻6)等用途。
關於藤茶萃取物,黃酮類化合物的白蘞素(ampelopsin)被鑑定作為擔任上述的各種各樣的作用的成分,得到大量含有該物質的萃取物。該物質,由乾燥後的藤茶莖葉經由水或含水酒精等的溶劑進行萃取,進一步市售有濃縮後的膏狀的濃縮物或噴霧乾燥或冷凍乾燥後的粉末。
藤茶萃取物,已知在用於含有藤茶萃取物的膠囊劑或錠劑化的製劑化步驟中,會產生藤茶萃取物具有的特有的令人不愉快的臭味(異味)。由於此異味在長期保存時會加重,必然不得不縮短保質期。
因此,尋求大量含有藤茶萃取物,長期保存也甚少產生異味,易於飲用的製劑。
[專利文獻1]日本特開2003-026584號公報
[專利文獻2]日本特開2003-012536號公報
[專利文獻3]日本特開2002-173424號公報
[專利文獻4]日本特開2002-159566號公報
[專利文獻5]日本特開2004-018756號公報
[專利文獻6]日本特開2002-065201號公報
本發明者們,以上述背景技術為基礎進行研究,在各種各樣的製劑化條件下對藤茶萃取物進行了研究,發現若將含有殼聚糖及藤茶萃
取物的組成物製劑化,則可以抑制藤茶萃取物特有的異味。基於如此的見識,本發明提出一種含有殼聚糖及藤茶萃取物的組成物及含有該組成物的錠劑或膠囊劑。
即,本發明的課題在於提供一種大量含有藤茶萃取物,且抑制了藤茶特有的異味(被評價為惡臭的臭味)的組成物及錠劑或膠囊劑。
本發明的主要構成如下所示。
(1)一種組成物,含有殼聚糖及藤茶萃取物,每份組成物含有10至35質量%的殼聚糖、5至22質量%的白蘞素,且殼聚糖/白蘞素的質量比為0.6至3.5。
(2)一種錠劑,係含有(1)所述的組成物。
(3)一種膠囊劑,係含有(1)所述的組成物。
根據本發明,提供抑制了藤茶萃取物的異味的組成物及錠劑、膠囊劑。特別根據本發明,長期的保存成為可能,並且由於來自藤茶萃取物的異味的產生得到抑制,從而可以成為即使對於老人或兒童也沒有抗拒感,容易吞嚥的製劑。
本發明係有關含有殼聚糖及藤茶萃取物的組成物、含有該組成物的錠劑或膠囊劑。
本發明的組成物的主要構成成分之一為殼聚糖。所謂殼聚糖,為主要具有藉由β1,4鍵與葡萄糖胺連接的構造,且有時除葡萄糖胺以外還含有N-乙醯葡糖胺作為構成成分的多糖類。
對於本發明中使用的殼聚糖的來源並無特別限制,例如可使用對藉由將鈣或蛋白質等從蝦、蟹等甲殼類動物的甲殼、墨魚骨等去除而得到的甲殼質進行脫乙醯化而得到的物質。
此外,對於本發明中使用的殼聚糖的脫乙醯化度並無特別限制。通常使用脫乙醯化度50至100%的物質即可。另外,殼聚糖的脫乙醯化度為根據膠體滴定法而測定的值。
此外進一步,對於本發明中使用的殼聚糖的平均分子量並無特別限制。
用於本發明的殼聚糖較佳係使用符合市售的食品原料的規格之粉末。
藤茶萃取物可以使用藤茶的葉、莖、花及根中的任意1種或2種以上的萃取物。特佳係利用莖或葉的萃取物。
從藤茶中萃取的方法並無特別限定。實施萃取時可以直接使用藤茶,或者使用其乾燥物,從萃取效率上而言,較佳為乾燥物。此外,粉碎至顆粒狀或粉末狀以供萃取的方式,可以在穩定的條件下短時間內以高萃取效率進行有效成分的萃取。萃取溫度並無特別限定,可以根據藤茶的粉碎物的粒徑或溶劑的種類等適當設定即可。
溶劑的種類並無特別限定。較佳為水、乙醇等低級醇或者此等的混合溶劑。萃取可以在常溫下進行。也可以在加熱的條件下(例如使用溫水或熱水等加熱後的溶劑)進行。
根據上述萃取操作,可以從藤茶中萃取本發明的有效成分,溶解在溶劑中。可以直接使用含有萃取物的溶劑。較佳係在根據需要實施了滅菌、洗滌、過濾、脫色、脫臭等常用的提純處理後使用。進一步,使溶劑全部揮發製成固體狀(乾燥物)。可以將該乾燥物再度溶解於任意的溶劑中,藉由進行噴霧乾燥等操作予以粉末化而使用。在本發明中,較佳係使用上述粉末。
另外,丸善製藥股份有限公司市售有藤茶萃取物(提取物),此等亦可使用。市售的藤茶萃取物係將藤茶的葉中大量含有的黃酮類化合物的一種之白蘞素作為指標並對萃取率進行管理並規範化的粉末,在本發明中也可以利用此粉末。
另外藤茶萃取物,在上述的膠囊劑化、錠劑化的製劑化工序中會產生極其特異的不期望的臭味(異味)。
對於含有殼聚糖和藤茶萃取物的組成物,為了抑制藤茶的臭味,將殼聚糖和藤茶萃取物的粉末均勻地混合。殼聚糖和藤茶萃取物的粉末,其調配量和調配比例非常重要。較佳係使每份組成物含有10至35質量%的殼聚糖。此外,較佳係使每份組成物中的白蘞素的濃度成為5至22質量%而含有藤茶萃取物。此外,使殼聚糖/白蘞素的質量比成為0.6至3.5而進行調配。
此外,含有殼聚糖和藤茶萃取物的組成物,為了藉由壓錠法製成錠劑,可以混合各種賦形劑,例如糖類或澱粉等,且可以根據需要實施粒化的操作製成顆粒劑。藉由將該顆粒劑或粉末遵循常規方法壓錠成型,可以得到抑制了藤茶萃取物的異味的錠劑。
製成膠囊劑時,根據常規方法將組成物填充至硬膠囊中製成膠囊劑。此時,在製成膠囊劑時,可以混合各種賦形劑,例如糖類或澱粉等,且可以根據需要實施粒化的操作製成顆粒劑。藉由將該顆粒劑或粉末組成物遵循常規方法填充至硬膠囊中,可以得到抑制了藤茶萃取物的異味的膠囊劑。
此外在製劑化中,作為可以作為賦形劑使用的物質為纖維素、澱粉、乳糖、麥芽糖醇、環糊精、半纖維素、瓜爾膠、蒟蒻甘露聚糖、海藻酸、瓊脂、卡拉膠、甲殼質、羧甲基纖維素及聚葡萄糖。特佳為纖維素或澱粉。
此外只要不阻礙本發明的目的,可以調配食用油、鈣、鐵、鈉、鋅、銅、鉀、磷、鎂、碘、錳及硒等礦物質,維生素A、維生素C、維生素D、維生素E、維生素K、煙酸、葉酸及泛酸等脂溶性或水溶性維生素群,甘油脂肪酸酯、蔗糖脂肪酸酯、山梨糖醇酐脂肪酸酯、丙二醇脂肪酸酯、磷脂、阿拉伯樹膠、黃原膠、黃蓍膠、槐豆膠、保存劑及抗氧化劑、調味劑或香料,氯化鈉、谷氨酸鈉、甘氨酸、琥珀酸及乳酸鈉等呈味劑,檸檬酸、檸檬酸鈉、乙酸、己二酸、富馬酸及蘋果酸等酸味劑,阿斯巴甜等低熱量甜味劑及著色劑等。
<錠劑>
以下,展示使用實施例、比較例的錠劑實施的試驗例,對本發明的效果進行說明。
1.臭味的評估方法
由於目前藤茶萃取物的臭味的本質還不明確,因此決定根據感官評估進行數值化。數值化係由熟練的專業感官評估人員藉由和標準品的2種比較法進行判斷,給出評分。關於標準品,製備以下的表1的組成的錠劑,將其作為標準品。另外,評估標準於表格的欄外進行明示。標準錠劑設置為 8mm、250mg/粒的錠劑,在將原料混合後,使用單沖式壓錠機(岡田精工公司製)以打擊壓1000kgf進行製備。
另外標準5至1的臭味的強度以上述表1中所記載的內容為標準,感官上相當於以下的表述。
標準5:幾乎感覺不到臭味。
標準4:感覺到些許臭味。
標準3:感覺到強烈的臭味但是並不影響飲用。
標準2:感覺到非常強烈的臭味,對於飲用感覺到抗拒。
標準1:感覺到難以飲用的臭味。
2.實施例1至6及比較例1至6的錠劑的製備和評估
根據表2的配方,將原料混合後,以單沖式壓錠機(岡田精工公司製)製作 8mm、250mg/粒的錠劑。將該錠劑20粒裝入鋁製袋中,在40℃75%RH的恆溫箱中保存2周後,由3名接受過專業的訓練的感官評估人員對開封時產生的臭味進行了評估。此外,以如上述製備的5種錠剤作為標準品,與此等藉由2種比較法對等同性進行了判斷。
評估的判定,例如,若試驗品為與標準3等同的令人不愉快的臭味,則評分為3。另外感官試驗結果,求取了3名的評分的平均值。結果如表2的最後一行所示
感官評估平均值4以上判斷為可降低令人不愉快的臭味。
由使用了實施例1至6及比較例1至6的錠劑的實驗結果可知,調配殼聚糖對於抑制含有藤茶萃取物的錠劑中的來自藤茶萃取物的特異性臭味有效。此外,在含有殼聚糖和藤茶萃取物的壓錠前的組成物中,若調整成每份組成物含有5至22質量%的白蘞素、10至35質量%的殼聚糖,且殼聚糖/白蘞素的質量比為0.6至3.5,則可以得到感受不到來自藤茶的特異性臭味的錠劑。
<膠囊劑>
以下,展示使用實施例、比較例的膠囊劑實施的試驗例,對本發明的效果進行說明。
1.臭味的評估方法
與錠劑的試驗相同,由熟練的專業感官評估人員藉由和標準品的2種比較法進行判斷,給出評分。關於標準品,製備以下的表3的組成的膠囊劑,將此作為標準品。另外,評估標準於表格的欄外進行明示。
此外,關於膠囊劑,在將原料混合後,使用硬膠囊填充機(Capsugel公司製“Profill 100”),製備膠囊尺寸2號的硬膠囊(膠囊殼為Capsugel公司製)。
另外標準5至1的臭味的強度以上述表3中所記載的內容為標準,感官上相當於以下的表述。
標準5:幾乎感覺不到臭味。
標準4:感覺到些許臭味。
標準3:感覺到強烈的臭味但是並不影響飲用。
標準2:感覺到非常強烈的臭味,對於飲用感覺到抗拒。
標準1:感覺到難以飲用的臭味。
2.實施例7至12及比較例7至12的膠囊劑的製備和評估
根據表4的配方,將原料混合後,和標準品同樣地使用硬膠囊填充機(Capsugel公司製“Profill 100”),製備膠囊尺寸2號的硬膠囊(膠囊殼為Capsugel公司製)劑。將該膠囊劑20粒密封入鋁製袋中,在40℃75%RH
的恆溫箱中保存2周後,由3名接受過專業的訓練的感官評估人員對開封時產生的臭味進行了評估。
另外,與上述製備的5種標準膠囊劑藉由2種比較法對等同性進行了判斷。
評估的判定,例如,若試驗品為與標準3等同的令人不愉快的臭味,則評分為3。另外感官試驗結果,求取了3名的評分的平均值。結果如表4的最後一行所示。
感官評估平均值4以上判斷為可降低令人不愉快的臭味。
由使用了實施例7至12及比較例7至12的膠囊劑的實驗結果可知,調配殼聚糖對於抑制含有藤茶萃取物的膠囊劑中的來自藤茶萃取物的特異性臭味有效。此外,在含有殼聚糖和藤茶萃取物的膠囊填充前的組成物中,若調整成每份組成物含有5至22質量%的白蘞素、10至35
質量%的殼聚糖,且殼聚糖/白蘞素的質量比為0.6至3.5,則可以得到感受不到來自藤茶的特異性臭味的膠囊劑。
Claims (3)
- 一種組成物,係含有殼聚糖及包含白蘞素之藤茶(Ampelopsis grossedentata)萃取物,每份組成物含有10至35質量%的殼聚糖,並且以含有9至21質量%的白蘞素之方式含有藤茶萃取物,且殼聚糖/白蘞素的質量比為0.6至3.5。
- 一種錠劑,係含有如申請專利範圍第1項所述的組成物。
- 一種膠囊劑,係含有如申請專利範圍第1項所述的組成物。
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