TW202038920A - 發泡性經口固形製劑 - Google Patents
發泡性經口固形製劑 Download PDFInfo
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- TW202038920A TW202038920A TW108147568A TW108147568A TW202038920A TW 202038920 A TW202038920 A TW 202038920A TW 108147568 A TW108147568 A TW 108147568A TW 108147568 A TW108147568 A TW 108147568A TW 202038920 A TW202038920 A TW 202038920A
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Abstract
本發明提供一種發泡性經口固形製劑,其提高舌、頜下腺唾液之分泌,使該舌、頜下腺唾液之分泌持續且對口腔黏膜或牙齒之牙釉質無危害性。 本發明之發泡性經口固形製劑含有以下之成分(A)、(B)及(C): (A)香辛料萃取物 0.001質量%以上且0.11質量%以下 (B)碳酸鹽 7質量%以上且40質量%以下 (C)有機酸或其鹽,且 成分(C)之酸基之莫耳數為50 mmol/100 g以上且600 mmol/100 g以下,成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25以上且3.0以下。
Description
本發明係關於一種發泡性經口固形製劑。
已知唾液對於維持口腔內之恆常性較為重要,具有自淨作用、緩衝作用、保護黏膜作用、抗菌/抗病毒作用。唾液腺主要有3個,即朝臉頰內側之黏膜開口之腮腺、朝舌下開口之舌下腺、及頜下腺。報告有如下情況:唾液之抗病毒作用在來自舌、頜下腺之唾液中之效果高於在來自腮腺之唾液中之效果(非專利文獻1)。由此可知,為了提高唾液之抗病毒效果而預防病毒感染症,促進舌、頜下腺唾液之分泌尤其有用。
迄今為止,報告有利用有機酸及碳酸鹽或碳酸氫鹽之碳酸發泡(專利文獻1)、屬於山椒屬之植物之果實、其粉碎物、其壓榨物或其等之萃取物(專利文獻2)會促進唾液分泌,提出有調配有發泡成分及香辛料萃取物之經口固形製劑。
(專利文獻1)日本專利特開2002-184號公報 (專利文獻2)日本專利特開2011-68642號公報
(非專利文獻1)Oral Microbiology Immunology 2009年、24(1)、p.18-24
本發明提供一種發泡性經口固形製劑,其含有以下之成分(A)、(B)及(C): (A)香辛料萃取物 0.001質量%以上且0.11質量%以下 (B)碳酸鹽 7質量%以上且40質量%以下 (C)有機酸或其鹽,且 成分(C)之酸基之莫耳數為50 mmol/100 g以上且600 mmol/100 g以下,成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)鹽之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25以上且3.0以下。
然而,有機酸之黏膜刺激性較強,無法為了提高唾液分泌量而調配足夠之量,又,會對口腔黏膜等產生危害性。又,發現利用有機酸及碳酸鹽或碳酸氫鹽之碳酸發泡存在唾液分泌不持續之問題。進而,關於藉由與香辛料萃取物組合所產生之舌、頜下腺唾液之分泌促進效果還未驗證。 本發明係關於提供一種發泡性經口固形製劑,其提高舌、頜下腺唾液之分泌,使該舌、頜下腺唾液之分泌持續,且對口腔黏膜無危害性。
本發明者進行了銳意研究,結果發現:藉由以特定量含有香辛料萃取物、碳酸鹽及有機酸或其鹽,且將碳酸鹽之莫耳數與有機酸或其鹽之酸基之莫耳數設為特定比,可獲得一種發泡性經口固形製劑,其不會對口腔黏膜等產生危害性,提高舌、頜下腺唾液之分泌,且其持續性亦優異。
根據本發明,可提供一種提高舌、頜下腺唾液之分泌,且使該舌、頜下腺唾液之分泌持續之發泡性經口固形製劑。本發明之發泡性經口固形製劑對口腔黏膜或牙齒之牙釉質無危害性,因此使用感亦良好。
於本說明書中,「發泡性經口固形製劑」意指於口腔內與唾液等水分接觸而產生二氧化碳之於20℃±15℃下為固形狀態之製劑。作為具體之製劑(劑型),例如可列舉錠劑(包括咀嚼錠等)、膠囊劑、顆粒劑、散劑、口含劑等。其中,就提高舌、頜下腺唾液分泌量之觀點、及提高舌、頜下腺唾液之分泌持續性之觀點而言,較佳為錠劑或口含劑,更佳為口含劑。
本發明之發泡性經口固形製劑含有香辛料萃取物作為成分(A)。 於本說明書中,「香辛料萃取物」係自香辛料獲得之萃取物,於常溫下可為液狀、固形狀、半固形狀之任一種形態。 香辛料並無特別限制,可使用自植物之種子、果實、葉、花、蕾、莖、樹皮、根塊、根莖等部位所製備者,例如可列舉胡椒、薑、辣椒、山崳菜、芥末、鼠尾草、百里香、山椒、蒜等。該等可使用1種或將2種以上組合而使用。其中,就提高舌、頜下腺唾液之分泌持續性之觀點而言,較佳為薑、辣椒,更佳為薑。
獲得香辛料萃取物之萃取方法可為浸漬、煎出、浸出、回流萃取、蒸餾、超臨界萃取、超音波萃取、微波萃取等之任一種。 萃取溶劑可為極性溶劑、非極性溶劑之任一種,例如可列舉:水;甲醇、乙醇等醇類;次臨界或超臨界二氧化碳;油脂、蠟等其他油類;以及該等之混合物。 關於萃取中之溶劑之使用量、萃取條件,只要為可進行充分萃取之條件,則無特別限定,可適當地進行調整。 香辛料萃取物可為粗純化物,亦可為視需要藉由液液分配、固液分配、過濾膜、活性炭、吸附樹脂、離子交換樹脂、澱出等公知之技術實施了非活性之夾雜物之去除、除臭、脫色等處理者。又,亦可適當地將公知之分離純化方法進行組合而提高純度。作為純化方法,可列舉有機溶劑沈澱、離心分離、限界濾膜、高效液相層析法或管柱層析法等。 香辛料萃取物可使用6-薑酚(6-Gingerol)(富士膠片和光純藥工業(股),純度100%)、6-薑醇(6-Shogaol)(富士膠片和光純藥工業(股),純度100%)等市售品,又,亦可使用薑萃取物粉末E(池田糖化工業(股))等利用糊精或麥芽糖醇等賦形劑將萃取物進行粉末化而成者等。
於成分(A)為薑萃取物之情形時,亦可分別單獨含有6-薑酚及6-薑醇,但較佳為含有6-薑酚及6-薑醇。就提高舌、頜下腺唾液之分泌持續性之觀點而言,薑萃取物較佳為相對於薑萃取物總量含有合計50質量%以上之6-薑酚及6-薑醇,更佳為含有80質量%以上,進而較佳為含有100質量%。即,薑萃取物較佳為6-薑酚及6-薑醇。 又,於成分(A)為辣椒萃取物之情形時,較佳為含有辣椒素。就提高舌、頜下腺唾液之分泌持續性之觀點而言,辣椒萃取物較佳為相對於辣椒萃取物總量含有50質量%以上之辣椒素,更佳為含有80質量%以上,進而較佳為含有100質量%。即,辣椒萃取物較佳為辣椒素。 6-薑酚及6-薑醇、以及辣椒素可依照以下揭示之實施例中所記載之方法進行分析。
同樣地,於成分(A)為胡椒萃取物之情形時,較佳為含有異胡椒鹼及胡椒鹼,於成分(A)為山崳菜萃取物之情形時,較佳為含有黑芥酸鉀,於成分(A)為芥末萃取物之情形時,較佳為含有黑芥酸鉀、異硫氰酸烯丙酯、白芥苷及異硫氰酸對羥基苄酯,於成分(A)為鼠尾草萃取物之情形時,較佳為含有shravan、蒎烯、桉樹腦及冰片,於成分(A)為百里香萃取物之情形時,較佳為含有瑞香草酚及香旱芹酚,山椒萃取物之有效成分較佳為含有山椒醇、雙戊烯、香茅醛、香葉草醇及水芹烯,於成分(A)為蒜萃取物之情形時,較佳為含有二烯丙基二硫醚、丙基烯丙基二硫醚及二烯丙基三硫醚。上述各萃取物較佳為相對於萃取物總量含有50質量%以上之上述各成分,更佳為含有80質量%以上,進而較佳為含有100質量%。異胡椒鹼、胡椒鹼、黑芥酸鉀、異硫氰酸烯丙酯、白芥苷、異硫氰酸對羥基苄酯、shravan、蒎烯、桉樹腦、冰片、瑞香草酚、香旱芹酚、山椒醇、雙戊烯、香茅醛、香葉草醇、水芹烯、二烯丙基二硫醚、丙基烯丙基二硫醚、二烯丙基三硫醚之分析可藉由通常已知之分析法中適合於測定試樣之情況之方法來進行分析。
本發明之發泡性經口固形製劑中之成分(A)之含量為0.001質量%以上且0.11質量%以下。藉由使製劑以該特定量含有成分(A),可提高舌、頜下腺唾液分泌量,且提高舌、頜下腺唾液之分泌之持續性。又,由於不會對口腔黏膜等產生危害性,故而可降低不快感。 關於發泡性經口固形製劑中之成分(A)之含量,就增加舌、頜下腺唾液分泌量之觀點、及提高舌、頜下腺唾液之分泌持續性之觀點而言,為0.001質量%以上,較佳為0.002質量%以上,更佳為0.005質量%以上,進而較佳為0.006質量%以上,進而更佳為0.008質量%以上,又,就降低黏膜之不快感之觀點而言,為0.11質量%以下,較佳為0.10質量%以下,更佳為0.07質量%以下,進而較佳為0.03質量%以下,進而較佳為0.025質量%以下。發泡性經口固形製劑中之成分(A)之含量為0.001~0.11質量%,較佳為0.002~0.10質量%,更佳為0.005~0.07質量%,進而較佳為0.006~0.03質量%,進而更佳為0.006~0.025質量%,尤佳為0.008~0.025質量%。
本發明之發泡性經口固形製劑含有碳酸鹽作為成分(B)。作為碳酸鹽,例如可列舉碳酸鈉、碳酸氫鈉、碳酸鉀、碳酸氫鉀、碳酸銨、倍半碳酸鈉等。該等可使用1種或將2種以上組合而使用。其中,就提高舌、頜下腺唾液分泌量之觀點而言,較佳為碳酸鈉、碳酸氫鈉、碳酸鉀,更佳為碳酸氫鈉。
本發明之發泡性經口固形製劑中之成分(B)之含量為7質量%以上且40質量%以下。藉由以該特定量含有成分(B),可提高舌、頜下腺唾液之分泌,增加舌、頜下腺唾液分泌量。 關於發泡性經口固形製劑中之成分(B)之含量,就增加舌、頜下腺唾液分泌量之觀點、及提高舌、頜下腺唾液之分泌持續性之觀點而言,為7質量%以上,較佳為10質量%以上,更佳為15質量%以上,又,就降低黏膜之不快感之觀點而言,為40質量%以下,較佳為35質量%以下,更佳為30質量%以下。發泡性經口固形製劑中之成分(B)之含量為7~40質量%,較佳為10~35質量%,更佳為15~30質量%。 於本說明書中,成分(B)之含量為碳酸換算值。
本發明之發泡性經口固形製劑中之成分(B)之莫耳數(mmol/100 g)係指換算成成分(B)中之碳酸離子或碳酸氫離子時之莫耳數。 關於發泡性經口固形製劑中之成分(B)之含量,就增加舌、頜下腺唾液分泌量之觀點、及提高舌、頜下腺唾液之分泌持續性之觀點而言,較佳為80 mmol/100 g以上,更佳為115 mmol/100 g以上,進而較佳為175 mmol/100 g以上,又,就降低黏膜之不快感之觀點而言,較佳為480 mmol/100 g以下,更佳為420 mmol/100 g以下,進而較佳為360 mmol/100 g以下。發泡性經口固形製劑中之成分(B)之莫耳數(mmol/100 g)較佳為80~480 mmol/100 g,更佳為115~420 mmol/100 g,進而較佳為175~360 mmol/100 g。
關於本發明之發泡性經口固形製劑中成分(A)相對於成分(B)之含有質量比[(A)/(B)],就增加舌、頜下腺唾液分泌量之觀點、提高舌、頜下腺唾液之分泌持續性之觀點、及降低黏膜之不快感之觀點而言,較佳為0.0001以上,更佳為0.0002以上,進而較佳為0.00025以上,又,就降低黏膜之不快感之觀點而言,較佳為0.0035以下,更佳為0.0015以下,進而較佳為0.001以下,進而更佳為0.0007以下。並且,成分(A)相對於成分(B)之含有質量比[(A)/(B)]較佳為0.0001~0.0035,更佳為0.0002~0.0015,進而較佳為0.0002~0.001,進而更佳為0.00025~0.0007。
本發明之發泡性經口固形製劑含有有機酸或其鹽作為成分(C)。有機酸或其鹽並無特別限制,較佳為選自羥基羧酸、二羧酸、抗壞血酸及該等之鹽中之1種或2種以上。 作為羥基羧酸,例如可列舉乳酸、檸檬酸、異檸檬酸、蘋果酸、酒石酸、葡萄糖酸、奎尼酸等。 作為二羧酸,例如可列舉草酸、丙二酸、琥珀酸、戊二酸、己二酸、富馬酸、馬來酸等。 抗壞血酸中包括作為立體異構物之L-抗壞血酸及異抗壞血酸。 作為鹽,較佳為鹼金屬鹽,進而較佳為選自鈉鹽及鉀鹽中之1種,進而較佳為鈉鹽。 其中,就增加舌、頜下腺唾液分泌量之觀點、提高舌、頜下腺唾液之分泌持續性之觀點、及降低黏膜之不快感之觀點而言,較佳為選自羥基羧酸、抗壞血酸及該等之鹽中之1種或2種以上,更佳為檸檬酸、酒石酸、L-抗壞血酸,就降低黏膜之不快感之觀點而言,進而較佳為檸檬酸。
本發明之發泡性經口固形製劑中之成分(C)之酸基之莫耳數(mmol/100 g)為50 mmol/100 g以上且600 mmol/100 g以下。藉由以成分(C)之酸基之莫耳數成為該特定量之方式含有成分(C),可提高舌、頜下腺唾液之分泌,增加舌、頜下腺唾液分泌量。又,可緩和有機酸之刺激而降低黏膜之不快感。 關於發泡性經口固形製劑中之成分(C)之酸基之莫耳數(mmol/100 g),就增加舌、頜下腺唾液分泌量之觀點、提高舌、頜下腺唾液之分泌持續性之觀點、及降低黏膜之不快感之觀點而言,為50 mmol/100 g以上,較佳為70 mmol/100 g以上,更佳為110 mmol/100 g以上,進而較佳為150 mmol/100 g以上,進而較佳為200 mmol/100 g以上,又,就同樣之觀點而言,為600 mmol/100 g以下,較佳為500 mmol/100 g以下,更佳為470 mmol/100 g以下,進而較佳為360 mmol/100 g以下,進而較佳為280 mmol/100 g以下。發泡性經口固形製劑中之成分(C)之酸基之莫耳數(mmol/100 g)為50~600 mmol/100 g,較佳為70~500 mmol/100 g,更佳為110~470 mmol/100 g,進而較佳為150~470 mmol/100 g,進而更佳為150~360 mmol/100 g,尤佳為200~280 mmol/100 g。 再者,於本發明中,將抗壞血酸作為具有1個酸基之有機酸而計算上述酸基之莫耳數。
關於本發明之發泡性經口固形製劑中之成分(C)之含量,就增加舌、頜下腺唾液分泌量之觀點、提高舌、頜下腺唾液之分泌持續性之觀點、及降低黏膜之不快感之觀點而言,較佳為5質量%以上,更佳為7質量%以上,進而較佳為10質量%以上,進而較佳為13質量%以上,又,就同樣之觀點而言,較佳為40質量%以下,更佳為30質量%以下,進而較佳為25質量%以下,進而較佳為18質量%以下。發泡性經口固形製劑中之成分(C)之含量較佳為5~40質量%,更佳為7~30質量%,進而較佳為10~25質量%,進而較佳為13~18質量%。 於本說明書中,成分(C)之含量為有機酸換算值。
本發明之發泡性經口固形製劑中成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25以上且3.0以下。藉由將碳酸鹽之莫耳數與有機酸或其鹽之酸基之莫耳數設為該特定比,可降低黏膜之不快感。又,可提高舌、頜下腺唾液之分泌,增加舌、頜下腺唾液分泌量,且其持續性亦提高。 關於成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol)],就增加舌、頜下腺唾液分泌量之觀點、提高舌、頜下腺唾液之分泌持續性之觀點、及降低黏膜之不快感之觀點而言,為0.25以上,較佳為0.3以上,更佳為0.5以上,進而較佳為0.8以上,又,就同樣之觀點而言,為3.0以下,較佳為2.6以下,更佳為2.5以下,進而較佳為2以下,進而較佳為1.5以下。成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25~3.0,較佳為0.3~2.6,更佳為0.3~2.5,進而較佳為0.5~2,進而較佳為0.5~1.5,進而更佳為0.8~1.5。
關於本發明之發泡性經口固形製劑中成分(B)相對於成分(C)之含有質量比[(B)/(C)],就增加舌、頜下腺唾液分泌量之觀點、提高舌、頜下腺唾液之分泌持續性之觀點、及降低黏膜之不快感之觀點而言,較佳為0.35以上,更佳為0.4以上,進而較佳為0.65以上,進而更佳為1.0以上,又,就同樣之觀點而言,較佳為4.0以下,更佳為3.3以下,進而較佳為2.7以下,進而更佳為2.0以下。並且,本發明之發泡性經口固形製劑中成分(B)相對於成分(C)之含有質量比[(B)/(C)]較佳為0.3~4.0,更佳為0.4~3.3,進而較佳為0.65~2.7,進而更佳為1.0~2.0。
又,關於本發明之發泡性經口固形製劑中成分(B)及(C)之合計量相對於成分(A)之含有質量比[((B)+(C))/(A)],就降低黏膜之不快感之觀點、增加舌、頜下腺唾液分泌量之觀點、及提高頜下腺唾液之分泌之持續性之觀點而言,較佳為500以上,更佳為1,000以上,進而較佳為3,000以上,又,較佳為30,000以下,更佳為20,000以下,進而較佳為7,000以下。並且,本發明之發泡性經口固形製劑中成分(B)及(C)之合計量相對於成分(A)之含有質量比[((B)+(C))/(A)]較佳為500~30,000,更佳為1,000~20,000,進而較佳為3,000~7,000。
本發明之發泡性經口固形製劑除上述成分以外,亦可於不損及本發明之效果之範圍內適當地調配甜味料、維生素、礦物質、表沒食子兒茶素沒食子酸酯、茶黃素或烏龍雙黃烷等茶兒茶素類、萃取物類、香料、著色料、防腐劑等。添加劑之含量可於不損及本發明之目的之範圍內適當地設定。
就降低黏膜之不快感之觀點而言,本發明之飲料用粉末食品中之成分(C)以外之酸味料之含量較佳為1質量%以下,更佳為0.5質量%以下,進而較佳為0.1質量%以下,進而更佳為實質上0質量%。
又,本發明之發泡性經口固形製劑視需要可含有容許之載體。例如可列舉:賦形劑(例如葡萄糖、半乳糖、果糖等單糖類;蔗糖、乳糖、麥芽糖、海藻糖、巴拉金糖等雙糖類;麥芽糖醇、木糖醇、赤藻糖醇、山梨糖醇、還原巴拉金糖等糖醇);結合劑(例如羥丙基甲基纖維素、羥丙基纖維素、明膠、α化澱粉、聚乙烯吡咯啶酮、聚乙烯醇、支鏈澱粉、甲基纖維素、氫化油等);崩解劑(例如羧甲基纖維素、羧甲基纖維素鈣、交聯羧甲基纖維素鈉、交聯聚維酮、玉米澱粉、低取代度羥丙基纖維素等);潤滑劑(例如硬脂酸鈣、硬脂酸鎂、蔗糖脂肪酸酯、硬脂富馬酸鈉、滑石、二氧化矽等);矯味劑(例如甜菊等);寡醣、瓊脂、結晶纖維素、粉末纖維素、輕質矽酸酐、磷酸氫鈣、增量劑、界面活性劑、分散劑、緩衝劑、稀釋劑等載體。載體之含量可於不損及本發明之目的之範圍內適當地設定。
其中,就降低黏膜之不快感之觀點、增加舌、頜下腺唾液分泌量之觀點、及提高頜下腺唾液之分泌之持續性之觀點而言,本發明之發泡性經口固形製劑較佳為含有糖醇。糖醇可為酸酐、水合物之任一者。 關於發泡性經口固形製劑中之糖醇之含量,就降低黏膜之不快感之觀點而言,較佳為10質量%以上,更佳為20質量%以上,進而較佳為30質量%以上,又,就增加舌、頜下腺唾液分泌量之觀點、及提高頜下腺唾液之分泌之持續性之觀點而言,較佳為85質量%以下,更佳為80質量%以下。發泡性經口固形製劑中之糖醇之含量較佳為10~85質量%,更佳為20~85質量%,進而較佳為30~80質量%。 作為糖醇之定量法,可利用HPLC(High Performance Liquid Chromatography,高效液相層析法)。例如,可使用胺基系管柱並藉由示差折射率檢測法進行分析(食物纖維基礎與應用 監修:日本食物纖維學會 編纂:日本食物纖維學會編纂委員會 其他作者:青木誠一郎 出版社:第一出版股份有限公司 發售日:2008年10月)。
作為本發明中用以將發泡性經口錠劑封入之密封容器,較佳為空氣不透過性容器、尤其是二氧化碳不透過性容器,可使用各種塑膠與鋁等金屬之層壓包裝容器、或蒸鍍有鋁、二氧化矽等之包裝容器、以及利用金屬、玻璃等之容器。此處言及之二氧化碳不透過性係指二氧化碳透過度為50 cc/m2
・day・atm(ASTD-1434)以下之性質。藉由將使用此種素材之容器密封等而進行密閉,能夠以二氧化碳不洩露之方式進行密封。
本發明之發泡性經口固形製劑可依照常規方法進行製造,可採用適當之方法。例如,可將成分(A)、成分(B)及成分(C)、視需要之載體及/或添加劑以成分(A)及成分(B)之含量、成分(C)之酸基之莫耳數成為上述範圍內且成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比成為上述範圍內之方式進行混合而製造。各成分之混合順序並無特別限定,可以任意順序添加,亦可同時添加。作為混合方法,可採用攪拌、振盪等適當之方法,亦可使用混合裝置。混合裝置之混合方式可為容器旋轉型,亦可為容器固定型。作為容器旋轉型,例如可採用水平圓筒型、V型、雙錐型、立方型等。又,作為容器固定型,例如可採用帶型、螺旋型、圓錐形螺旋型、槳型、流動層型、飛利浦攪拌機等。 又,亦可藉由公知之造粒法製成造粒物。作為造粒方法,例如可列舉噴霧造粒、流動層造粒、壓縮造粒、滾動造粒、攪拌造粒、擠出造粒、粉末被覆造粒等。造粒條件可根據造粒方法適當地進行選擇。
於製成錠劑之情形時,可將成分(A)、成分(B)及成分(C)、視需要之載體及/或添加劑之混合物作為原料粉末直接壓縮而成形,亦可藉由上述造粒方法進行造粒後利用壓錠成形機將造粒物進行壓縮而成形。 於直接或將造粒物進行壓縮而成形而製造錠劑之情形時,作為壓錠成形機,可使用旋轉式壓錠機或單銃式壓錠機等通常使用之壓錠成形機。 關於壓錠時之壓縮成形壓力,就維持成形物之硬度之觀點而言,較佳為10~30 MPa左右。 又,錠劑硬度較佳為可耐受搬運或保存等之硬度,較佳為10 N~200 N左右。 錠劑之形狀可為圓形或橢圓形、長圓形、四邊形等具有面形之各種異形錠,就服用性之觀點而言,較佳為圓形。於為圓形錠之情形時,就服用性之觀點而言,直徑較佳為3~30 mm,更佳為10~20 mm。又,就簡便性及有效性之方面而言,錠劑較佳為每一製劑設為0.1~6 g、進而為0.3~3 g之重量。
由於本發明之發泡性經口固形製劑使唾液中抗病毒活性較高之舌、頜下腺唾液之分泌量增加,進而使其分泌持續,故而作為要求日常頻繁之預防應對之流行性感冒、感冒等之預防病毒感染用之製劑較有用。
就降低黏膜之不快感之觀點、增加舌、頜下腺唾液分泌量之觀點、及提高頜下腺唾液之分泌之持續性之觀點而言,本發明之發泡性經口固形製劑較佳為如下之發泡性經口固形製劑,其含有以下之成分(A)、(B)及(C): (A)選自薑萃取物及辣椒萃取物中之1種以上 0.001質量%以上且0.11質量%以下 (B)碳酸鹽 7質量%以上且40質量%以下 (C)有機酸或其鹽,且 成分(C)之酸基之莫耳數為50 mmol/100 g以上且600 mmol/100 g以下,成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)鹽之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25以上且3.0以下,成分(B)及(C)之合計量相對於成分(A)之含有質量比[((B)+(C))/(A)]為500以上且30,000以下。
就降低黏膜之不快感之觀點、增加舌、頜下腺唾液分泌量之觀點、及提高舌、頜下腺唾液之分泌之持續性之觀點而言,本發明之發泡性經口固形製劑較佳為如下之發泡性經口固形製劑,其含有以下之成分(A)、(B)及(C): (A)選自薑萃取物及辣椒萃取物中之1種以上 0.001質量%以上且0.11質量%以下 (B)碳酸鹽 7質量%以上且40質量%以下 (C)有機酸或其鹽,且 成分(C)之酸基之莫耳數為50 mmol/100 g以上且600 mmol/100 g以下,成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)鹽之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25以上且3.0以下,成分(A)相對於成分(B)之含有質量比[(A)/(B)]為0.0001以上且0.0035以下,成分(B)及(C)之合計量相對於成分(A)之含有質量比[((B)+(C))/(A)]為500以上且30,000以下。
就降低黏膜之不快感之觀點、增加舌、頜下腺唾液分泌量之觀點、及提高舌、頜下腺唾液之分泌之持續性之觀點而言,本發明之發泡性經口固形製劑較佳為如下之發泡性經口固形製劑,其含有以下之成分(A)、(B)及(C): (A)薑萃取物 0.001質量%以上且0.11質量%以下 (B)碳酸鹽 7質量%以上且40質量%以下 (C)有機酸或其鹽,且 成分(C)之酸基之莫耳數為50 mmol/100 g以上且600 mmol/100 g以下,成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)鹽之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25以上且3.0以下,成分(A)相對於成分(B)之含有質量比[(A)/(B)]為0.0001以上且0.0035以下,成分(B)及(C)之合計量相對於成分(A)之含有質量比[((B)+(C))/(A)]為500以上且30,000以下。
關於上述實施形態,本發明揭示以下之發泡性經口固形製劑。
<1>一種發泡性經口固形製劑,其含有以下之成分(A)、(B)及(C): (A)香辛料萃取物 0.001質量%以上且0.11質量%以下 (B)碳酸鹽 7質量%以上且40質量%以下 (C)有機酸或其鹽,且 成分(C)之酸基之莫耳數為50 mmol/100 g以上且600 mmol/100 g以下,成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)鹽之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25以上且3.0以下。
<2>如<1>記載之發泡性經口固形製劑,其中成分(A)較佳為選自薑萃取物及辣椒萃取物中之1種或2種以上,更佳為薑萃取物。 <3>如<1>或<2>記載之發泡性經口固形製劑,其中成分(A)之含量為0.001質量%以上,較佳為0.002質量%以上,更佳為0.005質量%以上,進而較佳為0.006質量%以上,進而更佳為0.008質量%以上,又,為0.11質量%以下,較佳為0.10質量%以下,更佳為0.07質量%以下,進而較佳為0.03質量%以下,進而較佳為0.025質量%以下,又,為0.001~0.11質量%,較佳為0.002~0.10質量%,更佳為0.005~0.07質量%,進而較佳為0.006~0.03質量%,進而更佳為0.006~0.025質量%,尤佳為0.008~0.025質量%。 <4>如<1>至<3>中任一項記載之發泡性經口固形製劑,其中成分(B)較佳為選自碳酸鈉、碳酸氫鈉、碳酸鉀、碳酸氫鉀、碳酸鈣、碳酸鎂及倍半碳酸鈉中之1種或2種以上,更佳為選自碳酸鈉及碳酸氫鈉中之1種或2種,進而較佳為碳酸氫鈉。 <5>如<1>至<4>中任一項記載之發泡性經口固形製劑,其中成分(B)之含量為7質量%以上,較佳為10質量%以上,更佳為15質量%以上,又,為40質量%以下,較佳為35質量%以下,更佳為30質量%以下,又,為7~40質量%,較佳為10~35質量%,更佳為15~30質量%。 <6>如<1>至<5>中任一項記載之發泡性經口固形製劑,其中成分(B)之含量較佳為80 mmol/100 g以上,更佳為115 mmol/100 g以上,進而較佳為175 mmol/100 g以上,又,較佳為480 mmol/100 g以下,更佳為420 mmol/100 g以下,進而較佳為360 mmol/100 g以下,又,較佳為80~480 mmol/100 g,更佳為115~420 mmol/100 g,進而較佳為175~360 mmol/100 g。 <7>如<1>至<6>中任一項記載之發泡性經口固形製劑,其中成分(A)相對於成分(B)之含有質量比[(A)/(B)]較佳為0.0001以上,更佳為0.0002以上,進而較佳為0.00025以上,又,較佳為0.0035以下,更佳為0.0015以下,進而較佳為0.001以下,進而更佳為0.0007以下,又,較佳為0.0001~0.0035,更佳為0.0002~0.0015,進而較佳為0.0002~0.001,進而更佳為0.00025~0.0007。 <8>如<1>至<7>中任一項記載之發泡性經口固形製劑,其中成分(C)較佳為選自羥基羧酸、二羧酸、抗壞血酸及該等之鹽中之1種或2種以上,更佳為選自乳酸、檸檬酸、異檸檬酸、蘋果酸、酒石酸、葡萄糖酸、奎尼酸、草酸、丙二酸、琥珀酸、戊二酸、己二酸、富馬酸、馬來酸、L-抗壞血酸、異抗壞血酸及該等之鹽中之1種或2種以上,更佳為選自檸檬酸、蘋果酸、酒石酸、琥珀酸、富馬酸、L-抗壞血酸及該等之鹽中之1種或2種以上,進而較佳為選自檸檬酸、酒石酸、L-抗壞血酸及該等之鹽中之1種或2種以上,進而更佳為選自檸檬酸及該等之鹽中之1種或2種以上。 <9>如<1>至<8>中任一項記載之發泡性經口固形製劑,其中成分(C)之酸基之莫耳數(mmol/100 g)為50 mmol/100 g以上,較佳為70 mmol/100 g以上,更佳為110 mmol/100 g以上,進而較佳為150 mmol/100 g以上,進而較佳為200 mmol/100 g以上,又,為600 mmol/100 g以下,較佳為500 mmol/100 g以下,更佳為470 mmol/100 g以下,進而較佳為360 mmol/100 g以下,進而較佳為280 mmol/100 g以下,又,為50~600 mmol/100 g,較佳為70~500 mmol/100 g,更佳為110~470 mmol/100 g,進而較佳為150~470 mmol/100 g,進而更佳為150~360 mmol/100 g,尤佳為200~280 mmol/100 g。 <10>如<1>至<9>中任一項記載之發泡性經口固形製劑,其中成分(C)之含量較佳為5質量%以上,更佳為7質量%以上,進而較佳為10質量%以上,進而較佳為13質量%以上,又,較佳為40質量%以下,更佳為30質量%以下,進而較佳為25質量%以下,進而較佳為18質量%以下,又,較佳為5~40質量%,更佳為7~30質量%,進而較佳為10~25質量%,進而較佳為13~18質量%。 <11>如<1>至<10>中任一項記載之發泡性經口固形製劑,其中成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25以上,較佳為0.3以上,更佳為0.5以上,進而較佳為0.8以上,又,為3.0以下,較佳為2.6以下,更佳為2.5以下,進而較佳為2以下,進而較佳為1.5以下,又,為0.25~3.0,較佳為0.3~2.6,更佳為0.3~2.5,進而較佳為0.5~2,進而較佳為0.5~1.5,進而更佳為0.8~1.5。 <12>如<1>至<11>中任一項記載之發泡性經口固形製劑,其中成分(B)相對於成分(C)之含有質量比[(B)/(C)]較佳為0.35以上,更佳為0.4以上,進而較佳為0.65以上,進而更佳為1.0以上,又,較佳為4.0以下,更佳為3.3以下,進而較佳為2.7以下,進而更佳為2.0以下,又,較佳為0.3~4.0,更佳為0.4~3.3,進而較佳為0.65~2.7,進而更佳為1.0~2.0。 <13>如<1>至<12>中任一項記載之發泡性經口固形製劑,其中成分(B)及(C)之合計量相對於成分(A)之含有質量比[((B)+(C))/(A)]較佳為500以上,更佳為1,000以上,進而較佳為3,000以上,又,較佳為30,000以下,更佳為20,000以下,進而較佳為7,000以下,又,較佳為500~30,000,更佳為1,000~20,000,進而較佳為3,000~7,000。 <14>如<1>至<13>中任一項記載之發泡性經口固形製劑,其中成分(C)以外之酸味料之含量較佳為1質量%以下,更佳為0.5質量%以下,進而較佳為0.1質量%以下,進而更佳為實質上0質量%。 <15>如<1>至<14>中任一項記載之發泡性經口固形製劑,其進而含有糖醇。 <16>如<15>記載之發泡性經口固形製劑,其中糖醇之含量較佳為10質量%以上,更佳為20質量%以上,進而較佳為30質量%以上,又,較佳為85質量%以下,更佳為80質量%以下,又,較佳為10~85質量%,更佳為20~85質量%,進而較佳為30~80質量%。 <17>如<1>至<16>中任一項記載之發泡性經口固形製劑,其被封入至較佳為空氣不透過性容器、更佳為二氧化碳不透過性容器中。 <18>如<1>至<17>中任一項記載之發泡性經口固形製劑,其形態較佳為錠劑、膠囊劑、顆粒劑、散劑或口含劑,更佳為錠劑或口含劑,進而較佳為口含劑。 [實施例]
[6-薑酚、6-薑醇之分析] 6-薑酚、6-薑醇之含量係藉由高效液相層析法(HPLC)進行測定。將向試樣中添加水及甲醇並進行10分鐘超音波處理後進行定容所獲得者設為HPLC用分析試樣。 HPLC之分析條件如下所述。 <HPLC分析條件> 管柱:Inertsil ODS-2、4.6 mm×250 mm、5 μm(GL Science(股)) 管柱溫度:40℃ 檢測器:UV(ultraviolet,紫外線)=280 nm 流動相:水、乙腈、甲酸之混合液 流速:1.0 mL/min
[辣椒素之分析] 辣椒素之含量係藉由高效液相層析法(HPLC)進行測定。將向試樣中添加甲醇並進行10分鐘超音波處理後進行定容所獲得者設為HPLC用分析試樣。 HPLC之分析條件如下所述。 <HPLC操作條件> 管柱:Shim-pack FC-ODS4.6 mm×7.5 cm(SHIMADZU GLC(股)) 管柱溫度:50℃ 檢測器:螢光檢測器(激發波長:283 nm,測定波長:316 nm) 流動相:水、乙腈、乙酸之混合液 流速:1.0 mL/min
[碳酸鹽之分析] 發泡性經口固形製劑中之碳酸鹽之含量之分析方法如下所述。 採集發泡性經口固形製劑0.1~0.2 g,添加水10 mL及50%磷酸2 mL並栓緊。進行10分鐘超音波處理後,放置1小時而將頂隙氣體供於氣相層析儀而求出CO2
量,根據所產生之CO2
量算出。 <氣相層析儀操作條件> 機種:GC-14B、島津製作所(股) 檢測器:TCD(Thermal Conductivity Detector,熱導偵檢器) 管柱:Chromosorb101、80~100 mesh 玻璃管、3.2 mm×2 m 溫度:管柱50℃、注入口及檢測器100℃ 槽電流:75 mA 氣壓:氦氣(載體氣體)100 kPa 注入量:頂隙氣體0.2 mL
[有機酸之分析] 發泡性經口固形製劑中之有機酸之含量之分析方法如下所述。 採集發泡性經口固形製劑1 g,添加5%過氯酸20 mL,振盪10分鐘,藉此進行萃取。利用水將其定容為200 mL並進行10分鐘超音波處理。於過濾後供於高效液相層析儀(HPLC)。 <HPLC操作條件> 機種:LC-20AD、島津製作所(股) 檢測器:紫外可見吸光光度計SPD-20AV、島津製作所(股) 管柱:Shim-pack SCR-102H 300×80(長度×內徑(mm)) 島津製作所(股) 管柱溫度:40℃ 流動相:3 mmol/L之過氯酸 反應液:含有0.2 mmol/L溴瑞香草酚藍之15 mmol/L之磷酸氫二鈉溶液 流量:流動相1.0 mL/min、反應液1.4 mL/min 測定波長:445 nm
[原料] 薑萃取物:薑萃取物粉末E(池田糖化工業(股),6-薑酚之含量:0.93質量%,6-薑醇:2.30質量%,6-薑酚+6-薑醇:3.23質量%) 辣椒萃取物:辣椒素(富士膠片和光純藥工業(股)) 碳酸氫鈉:碳酸氫鈉(食品添加劑C)(Tosoh(股)) 檸檬酸:扶桑檸檬酸(酐)(扶桑化學工業(股)) 酒石酸:L-酒石酸(扶桑化學工業(股)) 抗壞血酸:L-抗壞血酸、Vitamin C TypeS(扶桑化學工業(股)) 麥芽糖醇:Amalty MR-50(三菱商事食品技術(股)) 粉末纖維素:KC Flock W400-G(NIPPON PAPER Chemicals(股)) 硬脂酸鈣:硬脂酸鈣(植物性)(太平化學產業(股)) 二氧化矽:Carplex FPS-500(DSL Japan)
實施例1~16及比較例1~14 以表1中所記載之調配組成將各成分進行混合。繼而,使用單銃式壓錠機(RIKEN製造)利用孔徑15 mm之環狀杵以18 MPa之壓錠壓力進行壓錠,獲得錠劑重量1 g/1錠、直徑15 mm之圓形錠劑。再者,於各組合物中,例如,於使用薑萃取物粉末E(池田糖化工業(股))製成錠劑之情形時,組合物中不可避免地含有糊精等賦形劑,但其等於表中未具體明示,包含於麥芽糖醇之含量中。 對所獲得之錠劑進行以下之評價。
[舌、頜下腺唾液分泌量] 對將上述各實施例及比較例中所獲得之錠劑於舌上靜置1分鐘時之舌、頜下腺唾液分泌量進行評價。評價基準設為如下,3名專業官能檢查員進行官能試驗,求出專業官能檢查員之評分之平均值,將小數點後第2位四捨五入而決定評價分數。再者,將服用時強烈確認到唾液分泌之實施例16評價為「5」,將略微確認到唾液分泌之比較例5評價為評價基準之「2」而以5個階段進行評價。評價基準
5:強烈確認到唾液分泌 4:確認到唾液分泌 3:稍微確認到唾液分泌 2:略微確認到唾液分泌 1:未確認到唾液分泌
[舌、頜下腺唾液分泌之持續性] 將上述各實施例及比較例中所獲得之錠劑於舌上靜置1分鐘後,將錠劑取出,對取出後10分鐘後之舌、頜下腺唾液分泌之持續性進行評價。評價基準設為如下,3名專業官能檢查員進行官能試驗,求出專業官能檢查員之評分之平均值,將小數點後第2位四捨五入而決定評價分數。再者,將服用時強烈確認到唾液分泌之實施例16評價為「5」,將略微確認到唾液分泌之比較例4評價為評價基準之「2」而以5個階段進行評價。評價基準
5:強烈確認到唾液分泌 4:確認到唾液分泌 3:稍微確認到唾液分泌 2:略微確認到唾液分泌 1:未確認到唾液分泌
[無黏膜之不快感] 對將上述各實施例及比較例中所獲得之錠劑於舌上靜置1分鐘時之黏膜之不快感進行評價。評價基準設為如下,3名專業官能檢查員進行官能試驗,求出專業官能檢查員之評分之平均值,將小數點後第2位四捨五入而決定評價分數。再者,將服用時完全感受不到刺激性味道所導致之不快感之實施例1評價為「5」,將強烈感受到刺激性味道所導致之不快感之比較例4評價為評價基準之「1」而以5個階段進行評價。評價基準
5:完全感受不到不快感 4:極少地感受到不快感 3:略微感受到不快感 2:感受到不快感 1:強烈感受到不快感 將結果示於表1-1及表1-2。
[表1-1]
(質量%) | 實施例1 | 實施例2 | 實施例3 | 實施例4 | 實施例5 | 實施例6 | 實施例7 | 實施例8 | 實施例9 | 實施例10 | 實施例11 | 實施例12 | 實施例13 | 實施例14 | 實施例15 | 實施例16 |
(A)薑萃取物1) | 0.002 | 0.002 | 0.002 | 0.002 | 0.006 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.03 | 0.03 | 0.03 | 0.10 |
(B)碳酸氫鈉 | 8.50 | 10.00 | 20.00 | 30.00 | 20.00 | 10.00 | 10.00 | 20.00 | 20.00 | 20.00 | 25.00 | 30.00 | 10.00 | 20.00 | 30.00 | 30.00 |
(C)檸檬酸 | 6.50 | 7.60 | 15.30 | 22.90 | 15.30 | 7.60 | 15.30 | 7.60 | 15.30 | 30.00 | 7.60 | 22.90 | 7.60 | 15.30 | 22.90 | 22.90 |
麥芽糖醇 | 77.00 | 74.40 | 56.70 | 39.10 | 56.69 | 74.39 | 66.69 | 64.39 | 56.69 | 41.99 | 59.39 | 39.09 | 74.37 | 56.67 | 39.07 | 39.00 |
粉末纖維素 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 |
硬脂酸鈣 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 |
二氧化矽 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 |
(合計) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
(B)之莫耳數[mmol/100 g] | 101.18 | 119.03 | 238.07 | 357.10 | 238.07 | 119.03 | 119.03 | 238.07 | 238.07 | 238.07 | 297.58 | 357.10 | 119.03 | 238.07 | 357.10 | 357.10 |
(C)之莫耳數[mmol/100 g] | 33.83 | 39.56 | 79.64 | 119.20 | 79.64 | 39.56 | 79.64 | 39.56 | 79.64 | 156.15 | 39.56 | 119.20 | 39.56 | 79.64 | 119.20 | 119.20 |
(C)之酸基之莫耳數[mmol/100 g] | 101.50 | 118.68 | 238.91 | 357.59 | 238.91 | 118.68 | 238.91 | 118.68 | 238.91 | 468.46 | 118.68 | 357.59 | 118.68 | 238.91 | 357.59 | 357.59 |
(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol) | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 0.50 | 2.01 | 1.00 | 0.51 | 2.51 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 |
(B)/(C) | 1.31 | 1.32 | 1.31 | 1.31 | 1.31 | 1.32 | 0.65 | 2.63 | 1.31 | 0.67 | 3.29 | 1.31 | 1.32 | 1.31 | 1.31 | 1.31 |
(B)+(C) | 15.00 | 17.60 | 35.30 | 52.90 | 35.30 | 17.60 | 25.30 | 27.60 | 35.30 | 50.00 | 32.60 | 52.90 | 17.60 | 35.30 | 52.90 | 52.90 |
(A)/(B) | 0.00024 | 0.00020 | 0.00010 | 0.00007 | 0.00030 | 0.00100 | 0.00100 | 0.00050 | 0.00050 | 0.00050 | 0.00040 | 0.00033 | 0.00300 | 0.00150 | 0.00100 | 0.00333 |
[(B)+(C)]/(A) | 7500.0 | 8800.0 | 17650.0 | 26450.0 | 5883.3 | 1760.0 | 2530.0 | 2760.0 | 3530.0 | 5000.0 | 3260.0 | 5290.0 | 586.7 | 1176.7 | 1763.3 | 529.0 |
舌、頜下腺唾液分泌量 | 3.7 | 3.7 | 4.3 | 4.7 | 4.7 | 3.7 | 4.3 | 4.0 | 4.7 | 4.0 | 4.0 | 5.0 | 4.0 | 4.7 | 5.0 | 5.0 |
舌、頜下腺唾液分泌之持續性 | 4.0 | 4.3 | 4.3 | 4.3 | 4.7 | 4.0 | 4.3 | 4.0 | 4.7 | 4.7 | 4.0 | 4.7 | 4.3 | 4.7 | 4.7 | 5.0 |
無黏膜之不快感 | 5.0 | 5.0 | 5.0 | 4.3 | 5.0 | 5.0 | 3.7 | 3.0 | 5.0 | 3.7 | 4.0 | 4.0 | 3.7 | 3.3 | 3.0 | 2.7 |
1)於表中之實施例中,薑萃取物為6-薑酚+6-薑醇,數值表示6-薑酚+6-薑醇合計量 |
[表1-2]
(質量%) | 比較例1 | 比較例2 | 比較例3 | 比較例4 | 比較例5 | 比較例6 | 比較例7 | 比較例8 | 比較例9 | 比較例10 | 比較例11 | 比較例12 | 比較例13 | 比較例14 |
(A)薑萃取物1) | 0.00 | 0.00 | 0.00 | 0.00 | 0.006 | 0.10 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.03 | 0.12 | 0.12 |
(B)碳酸氫鈉 | 20.00 | 30.00 | 0.00 | 0.00 | 0.00 | 0.00 | 10.00 | 10.00 | 20.00 | 20.00 | 5.00 | 5.00 | 20.00 | 30.00 |
(C)檸檬酸 | 15.30 | 22.90 | 7.60 | 15.30 | 0.00 | 0.00 | 2.00 | 40.00 | 2.00 | 40.00 | 3.80 | 3.80 | 15.30 | 22.90 |
麥芽糖醇 | 56.70 | 39.10 | 84.40 | 76.70 | 91.99 | 91.90 | 79.99 | 41.99 | 69.99 | 31.99 | 83.19 | 83.17 | 56.58 | 38.98 |
粉末纖維素 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 | 5.00 |
硬脂酸鈣 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 |
二氧化矽 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 |
(合計) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
(B)之莫耳數[mmol/100 g] | 238.07 | 357.10 | 0.00 | 0.00 | 0.00 | 0.00 | 119.03 | 119.03 | 238.07 | 238.07 | 59.52 | 59.52 | 238.07 | 357.10 |
(C)之莫耳數[mmol/100 g] | 79.64 | 119.20 | 39.56 | 79.64 | 0.00 | 0.00 | 10.41 | 208.20 | 10.41 | 208.20 | 19.78 | 19.78 | 79.64 | 119.20 |
(C)之酸基之莫耳數[mmol/100 g] | 238.91 | 357.59 | 118.68 | 238.91 | 0.00 | 0.00 | 31.23 | 624.61 | 31.23 | 624.61 | 59.34 | 59.34 | 238.91 | 357.59 |
(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol) | 1.00 | 1.00 | - | - | - | - | 3.81 | 0.19 | 7.62 | 0.38 | 1.00 | 1.00 | 1.00 | 1.00 |
(B)/(C) | 1.31 | 1.31 | - | - | - | - | 5.00 | 0.25 | 10.00 | 0.50 | 1.32 | 1.32 | 1.31 | 1.31 |
(B)+(C) | 35.30 | 52.90 | 7.60 | 15.30 | 0.00 | 0.00 | 12.00 | 50.00 | 22.00 | 60.00 | 8.80 | 8.80 | 35.30 | 52.90 |
(A)/(B) | - | - | - | - | - | - | 0.00100 | 0.00100 | 0.00050 | 0.00050 | 0.00200 | 0.00600 | 0.00600 | 0.00400 |
[(B)+(C)]/(A) | - | - | - | - | - | - | 1200.0 | 5000.0 | 2200.0 | 6000.0 | 880.0 | 293.3 | 294.2 | 440.8 |
舌、頜下腺唾液分泌量 | 3.7 | 4.3 | 2.7 | 3.3 | 2.0 | 3.3 | 2.0 | 3.3 | 2.0 | 4.0 | 2.0 | 2.0 | 4.3 | 5.0 |
舌、頜下腺唾液分泌之持續性 | 1.7 | 2.0 | 2.0 | 2.0 | 3.3 | 4.0 | 3.7 | 3.7 | 3.7 | 3.7 | 3.7 | 3.7 | 4.7 | 5.0 |
無黏膜之不快感 | 4.7 | 3.7 | 1.3 | 1.0 | 3.7 | 1.7 | 3.3 | 1.7 | 2.7 | 1.7 | 4.3 | 3.3 | 1.3 | 1.3 |
1)於表中之實施例中,薑萃取物為6-薑酚+6-薑醇,數值表示6-薑酚+6-薑醇合計量 |
實施例17及18 以表2中所記載之調配組成將各成分均勻地混合,並藉由與實施例1相同之方法獲得錠劑。 藉由與實施例1相同之方法對所獲得之錠劑進行測定與官能評價。將其結果示於表2。
[表2]
(質量%) | 實施例17 | 實施例18 | ||
(A)薑萃取物1 ) | 0.01 | 0.01 | ||
(B)碳酸氫鈉 | 20.00 | 20.00 | ||
(C) | 酒石酸 | 18.00 | 0.00 | |
抗壞血酸 | 0.00 | 40.00 | ||
麥芽糖醇 | 53.99 | 31.99 | ||
粉末纖維素 | 5.00 | 5.00 | ||
硬脂酸鈣 | 2.00 | 2.00 | ||
二氧化矽 | 1.00 | 1.00 | ||
(合計) | 100.00 | 100.00 | ||
(B)之莫耳數[mmol/100 g] | 238.07 | 238.07 | ||
(C)之莫耳數[mmol/100 g] | 119.93 | 227.12 | ||
(C)之酸基之莫耳數[mmol/100 g] | 239.86 | 227.12 | ||
(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol) | 0.99 | 1.05 | ||
(B)/(C) | 1.11 | 0.50 | ||
(B)+(C) | 38.00 | 60.00 | ||
(A)/(B) | 0.00050 | 0.00050 | ||
[(B)+(C)]/(A) | 3800.0 | 6000.0 | ||
舌、頜下腺唾液分泌量 | 4.7 | 4.7 | ||
舌、頜下腺唾液分泌之持續性 | 4.7 | 4.7 | ||
無黏膜之不快感 | 4.0 | 3.3 | ||
1)於表中之實施例中,薑萃取物為6-薑酚+6-薑醇,數值表示6-薑酚+6-薑醇合計量。 |
實施例19~21 以表3中所記載之調配組成將各成分均勻地混合,並藉由與實施例1相同之方法獲得錠劑。 藉由與實施例1相同之方法對所獲得之錠劑進行測定與官能評價。將其結果示於表3。
[表3]
(質量%) | 實施例19 | 實施例20 | 實施例21 |
(A)辣椒萃取物2) | 0.01 | 0.002 | 0.10 |
(B)碳酸氫鈉 | 20.00 | 20.00 | 20.00 |
(C)檸檬酸 | 15.30 | 15.30 | 15.30 |
麥芽糖醇 | 56.69 | 56.70 | 56.60 |
粉末纖維素 | 5.00 | 5.00 | 5.00 |
硬脂酸鈣 | 2.00 | 2.00 | 2.00 |
二氧化矽 | 1.00 | 1.00 | 1.00 |
(合計) | 100.00 | 100.00 | 100.00 |
(B)之莫耳數[mmol/100 g] | 238.07 | 238.07 | 238.07 |
(C)之莫耳數[mmol/100 g] | 79.64 | 79.64 | 79.64 |
(C)之酸基之莫耳數[mmol/100 g] | 238.91 | 238.91 | 238.91 |
(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol) | 1.00 | 1.00 | 1.00 |
(B)/(C) | 1.31 | 1.31 | 1.31 |
(B)+(C) | 35.30 | 35.30 | 35.30 |
(A)/(B) | 0.00050 | 0.00010 | 0.00500 |
[(B)+(C)]/(A) | 3530.0 | 17650.0 | 353.0 |
舌、頜下腺唾液分泌量 | 4.7 | 4.3 | 4.7 |
舌、頜下腺唾液分泌之持續性 | 4.7 | 4.3 | 5 |
無黏膜之不快感 | 4.3 | 4.3 | 2.3 |
2)於表中之實施例中,辣椒萃取物為辣椒素,數值表示辣椒素量。 |
根據表1~3確認到:藉由將成分(A)及成分(B)之含量、成分(C)之酸基之莫耳數設為特定範圍內,且使成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比成為特定範圍內,可獲得提高舌、頜下腺唾液之分泌,進而使舌、頜下腺唾液之分泌持續之發泡性經口固形製劑。又,該發泡性經口固形製劑之黏膜之不快感亦較少。
可藉由常規方法分別製備下文所示之配方作為本發明之發泡性經口固形製劑。
[配方例1 發泡性經口固形製劑] 茶黃素 0.5質量% 薑萃取物(6-薑酚及6-薑醇) 0.01質量% 碳酸氫鈉 20.00質量% 檸檬酸 15.30質量% 麥芽糖醇 56.19質量% 粉末纖維素 5.00質量% 硬脂酸鈣 2.00質量% 二氧化矽 1.00質量% 共計 100質量% [配方例2 發泡性經口固形製劑] 茶黃素 1.0質量% 薑萃取物(6-薑酚及6-薑醇) 0.01質量% 碳酸氫鈉 20.00質量% 檸檬酸 15.30質量% 麥芽糖醇 55.69質量% 粉末纖維素 5.00質量% 硬脂酸鈣 2.00質量% 二氧化矽 1.00質量% 共計 100質量% [配方例3 發泡性經口固形製劑] 茶黃素 2.0質量% 薑萃取物(6-薑酚及6-薑醇) 0.01質量% 碳酸氫鈉 20.00質量% 檸檬酸 15.30質量% 麥芽糖醇 54.69質量% 粉末纖維素 5.00質量% 硬脂酸鈣 2.00質量% 二氧化矽 1.00質量% 共計 100質量%
Claims (5)
- 一種發泡性經口固形製劑,其含有以下之成分(A)、(B)及(C): (A)香辛料萃取物 0.001質量%以上且0.11質量%以下 (B)碳酸鹽 7質量%以上且40質量%以下 (C)有機酸或其鹽,且 成分(C)之酸基之莫耳數為50 mmol/100 g以上且600 mmol/100 g以下,成分(B)之莫耳數(mol)與成分(C)之酸基之莫耳數(mol)的比[(B)之莫耳數(mol)/(C)之酸基之莫耳數(mol)]為0.25以上且3.0以下。
- 如請求項1之發泡性經口固形製劑,其中成分(A)為薑萃取物及/或辣椒萃取物。
- 如請求項1或2之發泡性經口固形製劑,其中成分(C)為選自羥基羧酸、抗壞血酸及該等之鹽中之1種或2種以上。
- 如請求項1或2之發泡性經口固形製劑,其中成分(B)及(C)之合計量相對於成分(A)之含有質量比[((B)+(C))/(A)]為500以上且30,000以下。
- 如請求項1或2之發泡性經口固形製劑,其進而含有10質量%以上且85質量%以下之糖醇。
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