JP6249398B2 - ビタミンb1誘導体組成物 - Google Patents
ビタミンb1誘導体組成物 Download PDFInfo
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- JP6249398B2 JP6249398B2 JP2013238410A JP2013238410A JP6249398B2 JP 6249398 B2 JP6249398 B2 JP 6249398B2 JP 2013238410 A JP2013238410 A JP 2013238410A JP 2013238410 A JP2013238410 A JP 2013238410A JP 6249398 B2 JP6249398 B2 JP 6249398B2
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
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Description
(A)ジセチアミンおよび/またはその塩
(B)アスパラギン酸類および/またはチオクト酸類
(1)以下の成分(A)および(B)
(A)ジセチアミンおよび/またはその塩
(B)アスパラギン酸類および/またはチオクト酸類
を含有することを特徴とする疲労予防および/または回復のための組成物、
(2)成分(A)がジセチアミン塩酸塩である上記(1)記載の組成物、
(3)成分(B)がL−アスパラギン酸および/またはその塩である上記(1)または(2)記載の組成物、
(4)成分(B)が、L−アスパラギン酸カリウムおよび/またはマグネシウムである上記(1)または(2)記載の組成物、
(5)チオクト酸類がチオクト酸アミドである上記(1)〜(4)いずれかに記載の組成物、
(6)ジセチアミン塩酸塩、L−アスパラギン酸カリウムおよびL−アスパラギン酸マグネシウムを含有することを特徴とする疲労予防および/または回復のための組成物、
に関する。
、強肝油等が挙げられる。
酸ナトリウム、ニコチン酸、ニコチン酸アミド、パンテノール、パントテン酸カルシウム
、パントテン酸ナトリウム、パンテチン、ビオチン、葉酸等が挙げられる。
ロール、コハク酸dl−α−トコフェロールカルシウム、酢酸d−α−トコフェロール、
酢酸dl−α−トコフェロール、d−α−トコフェロール、dl−α−トコフェロール等
が挙げられる。
酸、オロチン酸コリン、ガンマ−オリザノール、チオクト酸、チオクト酸アミド、塩化カ
ルニチン、ユビデカレノン、重酒石酸コリン、ルチン等が挙げられる。
リウム、炭酸マグネシウム、炭酸カルシウム、グルコン酸カルシウム、沈降炭酸カルシウ
ム、乳酸カルシウム、無水リン酸水素カルシウム、リン酸水素カルシウム、コンドロイチ
ン硫酸ナトリウム等が挙げられる。
イン等のカフェイン誘導体が挙げられる。
クトン、グルクロン酸、グルクロン酸アミド、グリチルリチン酸、グリチルリチン酸ナト
リウム、アミノエチルスルホン酸、ジクロロ酢酸ジイソプロピルアミン、メチルメチオニ
ンスルホニウムクロライド、肝臓加水分解物、ヨークレシチン等が挙げられる。
ンゾウ、クコシ、ケイヒ、コウジン、サフラン、サンザシ、サンヤク、シャクヤク、シュ
クシャ、ショウキョウ、ジョテイシ、セイヨウサンザシ、タイソウ、チョウジ、チンピ、
トウキ、トシシ、トチュウ、ニクジュヨウ、ニンジン、ブクリョウ、ムイラプアマ、モッ
コウ、ヤクチ、ヨクイニン、リョウガンニク、ローヤルゼリー、ロクジョウ等が挙げられ
る。
下記の方法に従って運動負荷実験を行った。
<試験方法>
7週齢のSlc:SD系雄性ラットを、プラスチック製ケージにおいて5日間の予備飼育を行なった。予備飼育後、第1回の被験薬物投与を行ない、底から1.5cmの高さまで水道水(水温:23℃±1℃)を入れたプラスチックケージ(以下、水浸用ケージともいう)にラットを速やかに移した。その後、試験初日から被験薬物を5日間、1日1回経口投与した。試験6日目、体重7%の錘をラットの尾根部にガムテープで取り付けた後、水道水の入った円形の水槽(直径:18cm、高さ:70cm、水深:40cm、水温23±1℃)中に入れ、遊泳開始からラットの鼻部が水面から10秒間沈むまでの時間(以下、遊泳時間ともいう)を測定した。
被験物質としては、ジセチアミン塩酸塩(以下、実施例において「DCET」と略す。)10mg/kg、アスパラギン酸(以下、実施例において「ASP」と略す。)100mg/kg、およびDCET 10mg/kgとASP 100mg/kgの組み合わせ(以下、実施例において、「DCET+ASP」と略す。)を用い、これらを0.5%メチルセルロース(以下、MCと略す)に懸濁して試験に供した。
結果を表1および図1に示した。
N=5〜10
*:p<0.05vsコントロールおよびDCET
バルジの方法による相乗効果の判定:1.97(DCET+ASP)>1.06(DCET)×1.25(ASP)
<試験方法>
DCETの投与量を30mg/kg、チオクト酸アミド(以下、実施例において「ALA」と略す。)10mg/kgとした他は、試験例1と同様の方法により実施した。結果を表2および図2に示す。
N=5〜10
*:p<0.05vsコントロールおよびDCET
バルジの方法による相乗効果の判定:2.18(DCET+ALA)>1.45(DCET)×1.33(ALA)
し、本発明の組成物の投与群(DCET+ASPまたはDCET+ALA)においてはコントロール群および各単独投与群と比較して、顕著な遊泳時間の増大が認められた。また、遊泳時間相対値は、試験例1においては、DCET投与群において1.06、ASP投与群において1.25であり、それらの積(1.32)はDCET+ASPの遊泳時間相対値(1.97)より小さく、試験例2においては、DCET投与群において1.45、ALA投与群において1.33であり、それらの積(1.92)はDCET+ALAの遊泳時間相対値(2.18)より小さく、バルジの方法により、(A)ジセチアミンおよび/またはその塩および成分(B)アスパラギン酸類および/またはチオクト酸類の組み合わせは、疲労予防及び/又は回復作用に関し相乗効果を発揮しているものと結論付けられた。
上記の結果より、本発明の医薬は、運動負荷に伴う肉体疲労及び水中環境における環境ストレスにより惹起される精神疲労に対して、(A)ジセチアミンおよび/またはその塩および成分(B)アスパラギン酸類および/またはチオクト酸類の併用による相乗的な疲労予防及び/又は回復作用を有することが明らかとなった。
下記の成分を含有する組成物(1日量、4錠中)を製造する。
*シアノコバラミンを60μg含有する。
**製剤用添加物として、モノラウリン酸ソルビタン、ゼラチン、白糖、タルク、グリセリン脂肪酸エステル、乳糖水和物、結晶セルロース、ヒドロキシプロピルセルロース、カルメロースカルシウム、ステアリン酸マグネシウム、ポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体、ヒプロメロース、酸化チタン、黄色三二酸化鉄、三二酸化鉄を含有する。
[錠剤製造法]
ジセチアミン塩酸塩水和物、リボフラビン、ピリドキシン塩酸塩、コハク酸d−α−トコフェロール、結晶セルロース、乳糖水和物およびカルメロースカルシウムを混合した混合末に精製水に溶解したヒドロキシプロピルセルロースを添加し、流動層造粒を行なう。乾燥し、調粒された調粒末に、理研ドライB12−B1CN−GP、L−アスパラギン酸マグネシウム・カリウム、結晶セルロース、カルメロースカルシウムおよびステアリン酸マグネシウムを混合し、均一になるまで混合する。混合物を打錠機にて打錠し、素錠(270mg)を得た。
素錠に対して、ポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体、ヒプロメロース、酸化チタン、黄色三二酸化鉄、三二酸化鉄、タルク、エタノールおよび精製水を含むスプレー液をスプレーしてフィルムコーティングを行い、フィルムコート錠(278mg)を得た。
Claims (6)
- 以下の成分(A)および(B)
(A)ジセチアミンおよび/またはその塩
(B)アスパラギン酸類および/またはチオクト酸類
を含有することを特徴とする疲労予防および/または回復のための組成物(ただし、組成物中の成分が、ユビデカレノン、アデノシン三リン酸及びその塩、ならびにニンニク加工物からなる群から選択される1以上の場合を除く。)。 - 成分(A)がジセチアミン塩酸塩である請求項1記載の組成物。
- 成分(B)がL−アスパラギン酸および/またはその塩である請求項1または2記載の組成物。
- 成分(B)が、L−アスパラギン酸カリウムおよび/またはマグネシウムである請求項1または2記載の組成物。
- チオクト酸類がチオクト酸アミドである請求項1〜4いずれかに記載の組成物。
- ジセチアミン塩酸塩、L−アスパラギン酸カリウムおよびL−アスパラギン酸マグネシウムを含有することを特徴とする疲労予防および/または回復のための組成物(ただし、組成物中の成分が、ユビデカレノン、アデノシン三リン酸及びその塩、ならびにニンニク加工物からなる群から選択される1以上の場合を除く。)。
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