JP2022551019A - ホルトノキ抽出物を有効成分として含むコロナウイルス治療剤 - Google Patents
ホルトノキ抽出物を有効成分として含むコロナウイルス治療剤 Download PDFInfo
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Abstract
Description
別途明示されない限り、本明細書で使用された成分、反応条件、成分の含量を表現するすべての数字、値および/または表現は、このような数字が本質的に異なるものうちでこのような値を得るのに発生する測定の多様な不確実性が反映された近似値であるから、すべての場合、「約」という用語により修飾されるものと理解されなければならない。また、本記載において数値範囲が開示される場合、このような範囲は、連続的であり、別途言及されない限り、このような範囲の最小値から最大値が含まれた前記最大値までのすべての値を含む。ひいては、このような範囲が整数を指す場合、別途言及されない限り、最小値から最大値が含まれた前記最大値までを含むすべての整数が含まれる。
以下、実施例、実験例および製造例を通じて本発明の構成および効果をさらに詳細に説明することとする。これらの実施例、実験例および製造例は、ただ本発明を例示するためのものに過ぎず、本発明の範囲がこれらの実施例により限定されるものではない。
済州島一帯の韓国産ホルトノキの葉を入手して乾燥した後、細切した後、ホルトノキ葉100kgを50%エタノール2,000Lで60℃で16時間抽出し、濾過および濃縮後、乾燥して、ホルトノキ抽出物28kg(収率28%)を得た。
Vero-E6細胞は、DMEM(-/-)で培養され、ウイルス感染実験時に、12well-plateに5×105cells/wellの濃度で接種した。37℃、CO2インキュベーターで24時間培養し、細胞培地を除去した後、1×PBSで2回水洗した。ホルトノキ抽出物を濃度別に(25、50、100 μg/mL)前処理した後、37℃、CO2インキュベーターで2時間培養し、以後、ウイルス感染のために細胞培地を除去した後、SARS-CoV-2ウイルスを50pfu/wellの濃度で1時間処理した。以後、細胞培地を除去した後、培地1.5mLを各wellに追加し、72時間反応させた後、結果を確認した。この際、SARS-CoV-2ウイルスに対して治療効果があると知られたレムデシビル(Remdesivir,Rem)5μMとマラリア治療剤クロロキノンホスフェート(Chloroquinone phosphate,C.P)10μMを比較群に設定して実験を進めた。
Vero-E6細胞は、DMEM(-/-)で培養され、12well-plateに5×105cells/wellの濃度で接種した。37℃、CO2インキュベーターで24時間培養し、細胞培地を除去した後、1×PBSで2回水洗した。ウイルス感染のためにSARS-CoV-2ウイルスを50pfu/wellの濃度で1時間処理し、以後、ホルトノキ抽出物が濃度別に(25、50、100 μg/mL)含有された培地1.5mLを各wellに追加し、72時間反応させた後、結果を確認した。この際、SARS-CoV-2ウイルスに対して治療効果があると知らされたレムデシビル(Remdesivir,Rem)5μMとマラリア治療剤クロロキノンホスフェート(Chloroquinone phosphate,C.P)10μMを比較群に設定して実験を進めた。
6週齢のハムスターを入手し、無作為でグループを設定した後、1週間安定化させた。ハムスターにSARS-CoV-2を感染させ、24時間後、4日間ホルトノキ抽出物を25、50、100 mg/kg の濃度で経口投与した。ウイルス投与前と投与後4日間、体重は毎日、体温は感染前後に1回ずつ測定した。
コロナウイルス感染症-19は、ウイルス感染による発熱を伴い、したがって、実験例3の実験で感染0日目と4日目となる日にハムスターの体温を測定することによって、コロナウイルス感染症-19の症状緩和効果を測定した。
コロナウイルス感染症-19は、ウイルス感染による体重減少を誘発し、したがって、実験例3の実験で感染0日目から4日目となる日まで全体5回ハムスター体重を測定することによって、体重減少抑制効果を測定した。
下記製剤例では、本発明の実施例1の抽出物を有効成分として含む薬学的組成物または食品組成物の製造例を説明した。下記製剤例は、本発明を具体的に説明するためのものであり、これにより本発明が限定されるものではない。
製剤例1-1:錠剤の製造
エタノール50gにポビドン10gを溶かして結合液を調製した後、有効成分150gを結合液に入れて均質に撹拌した。ケイ化微結晶セルロース130g、クロスカルメロースナトリウム15g、コロイドシリコンジオキシド20gを混合した後、有効成分と均質に撹拌させた結合液を投入して、顆粒工程を進行後、顆粒物を乾燥および整粒した。製造された顆粒物にクロスポビドン15gを入れて混合し、コロイドシリコンジオキシド3.5gとステアリン酸マグネシウム6.5gを入れ、滑沢工程を進行後、錠剤を製造した。
エタノール50gにポビドン19gを溶かして結合液を調製した後、有効成分150gを結合液に入れて均質に撹拌した。ケイ化微結晶セルロース143g、クロスカルメロースナトリウム15g、ノイシリン20gを混合した後、有効成分と均質に撹拌させた結合液を投入して、顆粒工程を進行後、顆粒物を乾燥および整粒した。製造された顆粒物にクロスポビドン15gを入れて混合し、コロイドシリコンジオキシド5gとステアリン酸マグネシウム8gを入れ、滑沢工程を進行後、錠剤を製造した。
エタノール50gにポビドン12.5gを溶かして結合液を調製した後、有効成分150gを結合液に入れて均質に撹拌した。ケイ化微結晶セルロース62.5g、乳糖水和物65g、クロスカルメロースナトリウム15g、コロイドシリコンジオキシド20gを混合した後、有効成分と均質に撹拌させた結合液を投入して、顆粒工程を進行後、顆粒物を乾燥および整粒した。製造された顆粒物にクロスポビドン15gを入れて混合し、コロイドシリコンジオキシド3.5gとステアリン酸マグネシウム6.5gを入れ、滑沢工程を進行後、錠剤を製造した。
エタノール33.5gにポビドン19gを溶かして結合液を調製した後、有効成分150gを結合液に入れて均質に撹拌した。ケイ化微結晶セルロース105g(主成分が含有しているエタノールの量分だけ、ケイ化微結晶セルロースの量を追加する)、クロスカルメロースナトリウム17.5g、ノイシリン20gを混合した後、有効成分と均質に撹拌させた結合液を投入して、顆粒工程を進行後、顆粒物を乾燥および整粒した。製造された顆粒物にクロスポビドン17.5gとケイ化微結晶セルロース33gを入れて混合し、コロイドシリコンジオキシド7.5gとステアリン酸マグネシウム8gを入れ、滑沢工程を進行後、錠剤を製造した。
前記製剤例1-1~1-4で製造した錠剤755mg(有効成分300mgを含む)を通常のパンコーティングシステム(Opadry(登録商標)、Opadry200(登録商標)またはOpaglos(登録商標))を用いてコーティング錠を製造した。
有効成分1g、塩化ナトリウム0.6gおよびアスコルビン酸0.1gを蒸留水に溶解させて100mlを製造した。この溶液を瓶に入れ、20℃で30分間加熱して滅菌させた。
有効成分1000mg、クエン酸1000mg、オリゴ糖100g、タウリン1gを混合して、これに精製水を加えて、全体体積が900mlになるようにした。約1時間85℃で撹拌加熱した後、製造された溶液を濾過して、滅菌された2リットル容器に入れて、密封滅菌して、飲料を製造した。
Claims (9)
- ホルトノキ(Elaeocarpus sylvestris)抽出物を有効成分として含む、コロナウイルス感染の予防、軽減または治療用薬学的組成物。
- 前記抽出物は、水、炭素数1~5の低級アルコールまたは炭素数1~5の低級アルコール水溶液の抽出物である、請求項1に記載のコロナウイルス感染の予防、軽減または治療用薬学的組成物。
- 前記抽出物は、30%~95%エタノール水溶液で抽出したものである、請求項1に記載のコロナウイルス感染の予防、軽減または治療用薬学的組成物。
- 前記抽出物は、40%~60%エタノール水溶液で抽出したものである、請求項1に記載のコロナウイルス感染の予防、軽減または治療用薬学的組成物。
- 前記ホルトノキ抽出物は、ホルトノキ葉抽出物である、請求項1に記載のコロナウイルス感染の予防、軽減または治療用薬学的組成物。
- 前記コロナウイルスは、ブタ伝染性胃腸炎ウイルス(TGEV,transmissble gastroenteritis virus)、ブタ流行性下痢ウイルス(PEDV,porcine epidemic diarrhea virus)、犬コロナウイルス(canine coronavirus)、牛コロナウイルス(bovine Coronavirus)、サルスコロナウイルス(SARS-CoV)およびコロナ-19ウイルス(SARS-CoV-2)よりなる群から1つ以上選ばれるものである、請求項1に記載のコロナウイルス感染の予防、軽減または治療用薬学的組成物。
- 前記薬学的組成物は、薬剤学的に許容可能な担体、賦形剤または希釈剤を含むものである、請求項1に記載のコロナウイルス感染の予防、軽減または治療用薬学的組成物。
- 前記薬学的組成物は、散剤、顆粒剤、錠剤、カプセル剤および液体形態よりなる群から選ばれて、経口投与するものである、請求項1に記載のコロナウイルス感染の予防、軽減または治療用薬学的組成物。
- ホルトノキ(Elaeocarpus sylvestris)抽出物を有効成分として含む、コロナウイルス感染の予防または改善用食品組成物。
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