JP6159128B2 - 抗ロタウイルス剤 - Google Patents
抗ロタウイルス剤 Download PDFInfo
- Publication number
- JP6159128B2 JP6159128B2 JP2013081783A JP2013081783A JP6159128B2 JP 6159128 B2 JP6159128 B2 JP 6159128B2 JP 2013081783 A JP2013081783 A JP 2013081783A JP 2013081783 A JP2013081783 A JP 2013081783A JP 6159128 B2 JP6159128 B2 JP 6159128B2
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- JP
- Japan
- Prior art keywords
- rotavirus
- salt
- agent
- cold
- tranexamic acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Description
感冒性胃腸炎を引き起こす代表的なウイルスとしては、ロタウイルスやノロウイルスが知られており、ロタウイルス感染症では、感冒性胃腸炎とともに呼吸器症状が1/3程度に発現する(以上、例えば、非特許文献2参照)。また、冬場の生後6ヶ月から2歳の乳幼児の嘔吐下痢症の原因の80%は、ロタウイルス感染といわれており、5歳までにほとんどの小児が感染し、保育所、幼稚園、小学校等の小児や、病院、老人ホーム、福祉施設等の成人でも集団発生がみられることがある。しかしながら、ロタウイルス感染症に対する治療法としては、有効な治療薬が未だに存在しないため、ワクチンの接種や、感染を防ぐための予防策がとられているにすぎないのが現状である。
さらに、トラネキサム酸には、抗インフルエンザウイルス作用(特許文献1参照)、抗アデノウイルス作用(特許文献2参照)を有することも報告されている。しかしながら、トラネキサム酸の抗ロタウイルス作用についての報告はない。一般的に、抗インフルエンザウイルス作用や抗アデノウイルス作用を有するからといっても、ウイルスの構造や感染作用メカニズムはそれぞれウイルスによって異なることから、他の種類のウイルスに対しても有効であるとはいえない。
すなわち本発明は、トラネキサム酸又はその塩を含有する、新規な抗ロタウイルス剤、並びに、ロタウイルス感染症の予防用及び/又は治療用の経口組成物であり、より詳しくは、トラネキサム酸又はその塩を有効成分とする感冒性胃腸炎の治療薬である。
(1)トラネキサム酸又はその塩を含有する、抗ロタウイルス剤。
(2)ロタウイルス感染症の予防及び/又は治療に用いる、(1)に記載の抗ロタウイルス剤。
(3)ロタウイルス感染症が、ロタウイルス感染による、発熱、上気道炎、及び、感冒性胃腸症である、(2)に記載の抗ロタウイルス剤。
(4)ロタウイルス感染症が、ロタウイルス感染による感冒性胃腸症である、(2)に記載の抗ロタウイルス剤。
(5)感冒性胃腸症が、胃腸症、嘔吐、及び/又は、下痢である、(4)に記載の抗ロタウイルス剤。
(6)さらに、解熱鎮痛薬、中枢神経興奮薬、鎮静剤、抗ヒスタミン薬、抗炎症薬、鎮咳薬、去痰薬、気管支拡張薬、抗アセチルコリン剤、殺菌消毒剤、局所麻酔剤、ビタミン剤、代謝性成分、生薬、及び、生薬抽出物、からなる群より選ばれる1種又は2種以上を含有する、(1)〜(5)のいずれか1に記載の抗ロタウイルス剤。
本発明におけるトラネキサム酸の塩の具体例としては、例えば、フッ化水素酸塩、塩酸塩、臭化水素酸塩、ヨウ化水素酸塩等のハロゲン化水素酸塩類;硝酸塩、過塩素酸塩、硫酸塩、リン酸塩等の無機酸塩類;メタンスルホン酸塩、トリフルオロメタンスルホン酸塩、エタンスルホン酸塩等の低級アルカンスルホン酸塩類;ベンゼンスルホン酸塩、p−トルエンスルホン酸塩等のアリールスルホン酸塩類;酢酸塩、リンゴ酸塩、フマル酸塩、コハク酸塩、クエン酸塩、アスコルビン酸塩、酒石酸塩、シュウ酸塩、マレイン酸塩等の有機酸塩類;
ナトリウム塩、カリウム塩等のアルカリ金属塩類;カルシウム塩、マグネシウム塩等のアルカリ土類金属塩類;N−メチルモルホリン塩、トリエチルアミン塩、トリブチルアミン塩、ジイソプロピルエチルアミン塩、ジシクロヘキシルアミン塩、N−メチルピペリジン塩、ピリジン塩、4−ピロリジノピリジン塩、ピコリン塩等の有機アミン塩類;及び、
グリシン塩、リジン塩、アルギニン塩、オルニチン塩、グルタミン酸塩、アスパラギン酸塩等のアミノ酸との塩類類;を挙げることができる。
(1)成分(6錠中、mg)
上記成分及び分量をとり、第15改正日本薬局方製剤総則「錠剤」の項に準じて錠剤を製造した。
(1)被験物質
トラネキサム酸は、第一三共プロファーマ(株)製のものを使用した。
ウイルスは、Human rotavirus VR-2018(ATCC)を使用した。
宿主細胞として、MA104細胞RCB0994(独立行政法人理化学研究所バイオリソースセンター)を使用した。
細胞増殖培地として、イーグルMEM培地に牛胎仔血清を10 %加えたものを使用した。また、細胞維持培地として、イーグルMEM培地を使用した。
細胞の培養として、細胞増殖培地を用い、使用細胞を組織培養用フラスコ内に単層培養した。単層培養後にフラスコ内から細胞増殖培地を除き、試験ウイルスを接種した。次に、細胞維持培地を加えて培養した。
ウイルス浮遊液の調製は、培養後、細胞に形態変化(細胞変性効果)が起こっていることを確認した。次に、培養液を遠心分離(3000 r/min、10分間)し、得られた上澄み液をウイルス浮遊液とした。
20μg/mLトリプシン含有細胞維持培地で調製した試験液を室温で30分保存した後、試験液0.9 mLにウイルス浮遊液0.1 mLを添加、混合後、試験液を用いて10倍段階希釈し、ウイルス感染価を測定した。
細胞増殖培地を用い、使用細胞を組織培養用マイクロプレート(96穴)内で単層培養した後、細胞増殖培地を除き、リン酸緩衝生理食塩水を加えた。リン酸緩衝生理食塩水を除いた後、細胞維持培地を0.1 mLずつ加えた。次に、ウイルス浮遊液を添加した試験液及びその希釈液0.1 mLを4穴ずつに接種し、14日間培養した。培養後細胞の形態変化(細胞変性効果)の有無を観察し、Reed-Muench法により50 %組織培養感染量(TCID50)を算出してウイルス浮遊液1 mL当たりのウイルス感染価に換算した。
トラネキサム酸のウイルス感染価を測定した結果を表2に示す。表2より、トラネキサム酸の添加により、濃度依存的にウイルス感染価(log TCID50/mL)の低下が認められ、トラネキサム酸が抗ロタウイルス作用を有することが確認された。
*1:室温で30分保存したもの
*2:ウイルス浮遊液1 mL当たりのTCID50の対数値
対照群:検体未添加の20μg/mLトリプシン含有細胞維持培地
Claims (2)
- ロタウイルス感染による感冒性胃腸症に用いられる、トラネキサム酸又はその塩を含有する、抗ロタウイルス剤。
- 感冒性胃腸症が、胃腸症、嘔吐、及び/又は、下痢である、請求項1に記載の抗ロタウイルス剤。
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