JP2016193894A - 生菌含有製剤 - Google Patents
生菌含有製剤 Download PDFInfo
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- JP2016193894A JP2016193894A JP2016067070A JP2016067070A JP2016193894A JP 2016193894 A JP2016193894 A JP 2016193894A JP 2016067070 A JP2016067070 A JP 2016067070A JP 2016067070 A JP2016067070 A JP 2016067070A JP 2016193894 A JP2016193894 A JP 2016193894A
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- bacteria
- solid preparation
- starch
- useful
- agent
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Abstract
Description
本発明として、例えば、下記のものを挙げることができる。
[1]腸内有用菌、および乾燥減量値が4%以下のデンプンを5〜35質量%の範囲内で含むことを特徴とする、固形製剤。
[2]固形製剤が、錠剤、カプセル剤、散剤、または顆粒剤である、上記[1]に記載の固形製剤。
[3]固形製剤が錠剤である、上記[1]に記載の固形製剤。
[4]腸内有用菌が、乳酸菌、ビフィズス菌、糖化菌、および酪酸菌からなる群から選ばれる一種以上の菌である、上記[1]〜[3]のいずれか一項に記載の固形製剤。
[5]腸内有用菌が、乳酸菌、ビフィズス菌からなる群から選ばれる一種以上の菌である、上記[1]〜[3]のいずれか一項に記載の固形製剤。
[7]デンプンが、トウモロコシデンプン、コメデンプン、コムギデンプン、またはバレイショデンプンである、上記[1]〜[6]のいずれか一項に記載の固形製剤。
[8]添加剤としてアメ粉、乳糖水和物、またはD−マンニトールを含む、上記[1]〜[7]のいずれか一項に記載の固形製剤。
[10]固形製剤が錠剤であって、直接打錠することによって製造される、上記[9]に記載の固形製剤の製造法。
[11]腸内有用菌が、乳酸菌、ビフィズス菌、糖化菌、および酪酸菌からなる群から選ばれる一種以上の菌である、上記[9]または[10]に記載の固形製剤の製造法。
[12]腸内有用菌が、乳酸菌およびビフィズス菌からなる群から選ばれる一種以上の菌である、上記[9]または[10]に記載の固形製剤の製造法。
[14]デンプンが、トウモロコシデンプン、コメデンプン、コムギデンプン、またはバレイショデンプンである、上記[9]〜[13]のいずれか一項に記載の固形製剤の製造法。
[15]添加剤としてアメ粉、乳糖水和物、またはD−マンニトールを含む、上記[9]〜[14]のいずれか一項に記載の固形製剤の製造法。
1 本発明製剤
本発明製剤は、腸内有用菌、および乾燥減量値が4%以下のデンプン(以下、単に「デンプン」ともいう。)を5〜35質量%の範囲内で含むことを特徴とする。
腸内有用菌は、消化吸収の補助や免疫刺激などによって、人体の健康維持や老化防止などに有用な腸内細菌である。本発明に係る腸内有用菌は、そのような腸内細菌であれば特に制限されないが、具体的には、例えば、乳酸菌、ビフィズス菌、糖化菌、酪酸菌を挙げることができる。
本発明で用いうるデンプンは、乾燥減量値が4%以下のものであれば特に制限されない。好ましくは3%以下、より好ましくは2%以下のものである。乾燥減量値が小さいデンプンほどよいが、下限値として0.05%または0.1%程度を挙げることができる。
本発明製剤には、腸内有用菌以外の有効成分を配合することができる。その種類は特に制限されないが、そのような有効成分として、例えば、制酸剤、健胃剤、消化剤、整腸剤、止瀉剤、鎮痛鎮痙剤、ビタミン剤、粘膜修復剤、消泡剤、解熱鎮痛消炎薬、向精神薬、抗不安薬、抗うつ薬、催眠鎮静薬、鎮痙薬、中枢神経作用薬、脳代謝改善剤、脳循環改善剤、抗てんかん剤、交感神経興奮剤、胃腸薬、抗潰瘍剤、鎮咳去痰剤、鎮吐剤、呼吸促進剤、気管支拡張剤、アレルギー用薬、歯科口腔用薬、抗ヒスタミン剤、強心剤、不整脈用剤、利尿薬、血圧降下剤、血管収縮薬、冠血管拡張薬、末梢血管拡張薬、高脂血症用剤、利胆剤、抗生物質、化学療法剤、糖尿病用剤、骨粗しょう症用剤、抗リウマチ薬、骨格筋弛緩薬、鎮けい剤、ホルモン剤、アルカロイド系麻薬、サルファ剤、痛風治療薬、血液凝固阻止剤、抗悪性腫瘍剤を挙げることができる。これらの具体例としては、次のものを挙げることができる。
本発明製剤の製剤化のためなどに含みうる添加剤としては、剤形や含有する腸内有用菌の種類、配合する他の薬剤の種類などによって異なるが、例えば、賦形剤、崩壊剤、滑沢剤、甘味剤、矯味剤、流動化剤、安定化剤、緩衝剤、可溶化剤、結合剤、コーティング剤が挙げられる。
本発明製剤が採りうる剤形としては、特に制限されないが、例えば、錠剤、散剤、顆粒剤、カプセル剤を挙げることができる。この中、錠剤、カプセル剤が好ましく、錠剤がより好ましい。
本発明は、乾燥減量値が4%以下のデンプンおよび腸内有用菌、ならびに一種以上の添加剤を含む組成物を用い、造粒工程を経ないで製造されることを特徴とする固形製剤の製造法(以下、「本発明製造法」という。)を含む。
腸内有用菌は、一般に水分により死滅しやすいことから、製剤の平衡相対湿度ERH(Equii Rerative Humidity)(水分活性(Water Activity))が0〜40%、好ましくは0〜30%、より好ましくは0〜25%となるように管理保存することが好ましい。
錠剤硬度計(機種:PTB311E, Pharma Test GmbH Germany社製)を用いて測定した。なお、試験に用いた錠数を試験結果に記す。
(2)崩壊試験
第十六改正日本薬局方・崩壊試験法に記載の方法に従って測定した。
第十六改正日本薬局方・錠剤の摩損度試験法に記載の方法に従い測定した。
(4)乳酸菌の測定
乳酸菌の生菌数は、混合末又は錠剤に希釈液を加えて調製した試料溶液を塗沫法によりカンテンに塗布し、嫌気培養法により測定した。
納豆菌の測定は、混合末又は錠剤に希釈液を加えて調製した試料溶液を混釈法によりカンテンに分注して平板に固め、好気培養法により測定した。
(6)酪酸菌の測定
酪酸菌の測定は、混合末又は錠剤に希釈液を加えて調製した試料溶液を塗沫法によりカンテンに塗布し、嫌気培養法により測定した。
乳酸菌(ラクトミン、天野エンザイム社製) 、アメ粉(サンマルト(登録商標)ミドリ、株式会社林原製)、乾燥減量値が0.3〜12.0%のトウモロコシデンプンおよびステアリン酸マグネシウム(太平化学社製)を表1または2に示す組成で秤量し、ポリ袋内で混合し混合末とした。なお、乾燥減量値が0.3%のトウモロコシデンプンはトウモロコシデンプンST−C(日澱化学社製、0.3%)を用い、12%のトウモロコシデンプンはトウモロコシデンプン(コーンスターチ、日本食品化工社製)を用い、それ以外は上記2種のトウモロコシデンプンを組み合わせて調製した。
実施例1のトウモロコシデンプンをバレイショデンプン(バレイショデンプンST−P(日澱化学社製)、乾燥減量0.5%)に置き換え同様に混合末とした。
実施例1のアメ粉を乳糖水和物(Pharmatose 200M, DMV、実施例5)あるいはD−マンニトール(PEARLITOL 160C,ロケット社製、実施例6)に置き換え同様に混合末とした。
乳酸菌(ラクトミン、天野エンザイム社製) 、アメ粉(サンマルト(登録商標)ミドリ、株式会社林原製)、トウモロコシデンプンST−C(日澱化学社製、乾燥減量0.3%)およびステアリン酸マグネシウム(太平化学社製)を表3に示す組成で秤量し、ポリ袋内で混合し混合末とした。
実施例7のトウモロコシデンプンを3%、アメ粉を95%とした混合末(比較例5)、トウモロコシデンプンを40%、アメ粉を58%とした混合末(比較例6)、トウモロコシデンプンを50%、アメ粉を48%とした混合末(比較例7)を同様の方法で得た。
実施例7〜9および比較例5〜7の混合末をロータリー打錠機(VIRGO、株式会社菊水製作所製)により打錠し、それぞれ実施例10〜12および比較例8〜10の錠剤を得た(質量200mg/錠、錠剤形状:8.0mmφ、平面)。
実施例1〜3および比較例1〜4の混合末を各々ガラス瓶に入れて密栓した後、50℃で、1日および3日間保管した。これら混合末の初期および保管後の生菌数を測定し残菌率を求めた結果を表4に示す。
実施例4の混合末をガラス瓶に入れて密栓した後、50℃で3日間保管した。この混合末の初期および保管品の生菌数を測定し残菌率を求めた結果36%であった。
実施例5および6の混合末を各々ガラス瓶に入れて密栓した後、50℃で3日間保管した。これら混合末の初期および保管品の生菌数を測定し残菌率を求めた結果、それぞれ79%と90%であった。
実施例7〜9および比較例5〜7の混合末を各々ガラス瓶に入れて密栓した後、50℃で3日間保管した。そして、これら混合末の初期および保管品の生菌数を測定し残菌率を求めた。その結果を表5に示す。
実施例7〜9の混合末より得られた錠剤(実施例10〜12)について、成形前の混合末および錠剤中の乳酸菌数を測定し、打錠時の乳酸菌の残菌率を求めた。また、錠剤の硬度を測定した。その結果を表6に示す。
コンクビオゼニン(2%)、ビフィズス菌(0.5%)、ビオナットミン(2%)、酪酸菌(4%)、ニコチン酸アミド(0.2%)、ビオヂアスターゼ(1%)、炭酸カルシウム(20%)、アメ粉(58%)、トウモロコシデンプン(10%、乾燥減量0.3%)、軽質無水ケイ酸(0.1%)、ステアリン酸マグネシウム(1%)および香料を混合機で混合し、この混合末をロータリー式打錠機(VIRGO、株式会社菊水製作所製)により1錠当たり250mgの錠剤(8mmφ、R形状)を製造した。
実施例14の錠剤を乾燥剤とともに錠剤瓶に入れ、40℃,75%RHに保管した。
6ヵ月保存後の生菌数の残菌率、錠剤硬度、崩壊時間を表7に示す。
ビオナットミン(5%)、ビフィズス菌(1%)、乳酸菌(有胞子)(2%)、ニコチン酸アミド(0.1%)、ビオヂアスターゼ(1%)、炭酸カルシウム(21%)、アメ粉(59%)、トウモロコシデンプン(10%、乾燥減量0.3%品)、軽質無水ケイ酸(0.1%)、ステアリン酸マグネシウム(1%)および香料を混合機で混合し、この混合末をロータリー式打錠機(VIRGO、株式会社菊水製作所製)により1錠当たり240mgの錠剤(8mmφ、R形状)を製造した。
実施例15の錠剤を乾燥剤とともに錠剤瓶に入れ、40℃,75%RHに保管した。
6ヵ月保存後の生菌数の残菌率、錠剤硬度、崩壊時間を表8に示す。
Claims (15)
- 腸内有用菌、および乾燥減量値が4%以下のデンプンを5〜35質量%の範囲内で含むことを特徴とする、固形製剤。
- 固形製剤が、錠剤、カプセル剤、散剤、または顆粒剤である、請求項1に記載の固形製剤。
- 固形製剤が錠剤である、請求項1に記載の固形製剤。
- 腸内有用菌が、乳酸菌、ビフィズス菌、糖化菌、および酪酸菌からなる群から選ばれる一種以上の菌である、請求項1〜3のいずれか一項に記載の固形製剤。
- 腸内有用菌が、乳酸菌およびビフィズス菌からなる群から選ばれる一種以上の菌である、請求項1〜3のいずれか一項に記載の固形製剤。
- さらに、制酸剤、健胃剤、消化剤、整腸剤、止瀉剤、鎮痛鎮痙剤、ビタミン剤、粘膜修復剤、および消泡剤からなる群から選ばれる一種以上の有効成分を含む、請求項1〜5のいずれか一項に記載の固形製剤。
- デンプンが、トウモロコシデンプン、コメデンプン、コムギデンプン、またはバレイショデンプンである、請求項1〜6のいずれか一項に記載の固形製剤。
- 添加剤としてアメ粉、乳糖水和物、またはD−マンニトールを含む、請求項1〜7のいずれか一項に記載の固形製剤。
- 乾燥減量値が4%以下のデンプンおよび腸内有用菌、ならびに一種以上の添加剤を含む組成物を用い、造粒工程を経ないで製造されることを特徴とする、固形製剤の製造法。
- 固形製剤が錠剤であって、さらに直接打錠することによって製造される、請求項9に記載の固形製剤の製造法。
- 腸内有用菌が、乳酸菌、ビフィズス菌、糖化菌、および酪酸菌からなる群から選ばれる一種以上の菌である、請求項9または10に記載の固形製剤の製造法。
- 腸内有用菌が、乳酸菌およびビフィズス菌からなる群から選ばれる一種以上の菌である、請求項9または10に記載の固形製剤の製造法。
- さらに、制酸剤、健胃剤、消化剤、整腸剤、止瀉剤、鎮痛鎮痙剤、ビタミン剤、粘膜修復剤、および消泡剤からなる群から選ばれる一種以上の有効成分を含む、請求項9〜12のいずれか一項に記載の固形製剤の製造法。
- デンプンが、トウモロコシデンプン、コメデンプン、コムギデンプン、またはバレイショデンプンである、請求項9〜13のいずれか一項に記載の固形製剤の製造法。
- 添加剤としてアメ粉、乳糖水和物、またはD−マンニトールを含む、請求項9〜14のいずれか一項に記載の固形製剤の製造法。
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