JP2021525242A - 新たな医薬品使用 - Google Patents
新たな医薬品使用 Download PDFInfo
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- JP2021525242A JP2021525242A JP2020565331A JP2020565331A JP2021525242A JP 2021525242 A JP2021525242 A JP 2021525242A JP 2020565331 A JP2020565331 A JP 2020565331A JP 2020565331 A JP2020565331 A JP 2020565331A JP 2021525242 A JP2021525242 A JP 2021525242A
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Abstract
Description
Ala−Lys−Pro−Ser−Tyr−Hyp−Hyp−Thr−Tyr−Lys、
を含むか、または好ましくはそれからなる、(単離された)ペプチド化合物、その位置異性体、立体異性体、または塩が提供される。
(a)口腔粘膜炎、アフタ性潰瘍、中耳炎、喉頭炎、気管炎、食道炎、胃炎、腸炎、および全腸炎(細菌性赤痢、慢性アメーバ性赤痢、住血吸虫症、非特異的潰瘍性大腸炎、および局所腸炎を含む)、子宮頸管炎および子宮内膜炎、子宮内膜炎、吸入傷害などによって引き起こされる炎症、ならびにがんに関連する粘膜の炎症、および口腔、鼻咽頭、耳、喉、気管、胃腸管、子宮頸部などの粘膜表面に影響を及ぼす、感染(例えば、風邪もしくはインフルエンザなどのウイルス感染)などの粘膜炎症。
●ゲル製剤(これの好適なゲルマトリックス材料には、セルロース誘導体、カルボマーおよびアルギン酸塩、トラガントガム、ゼラチン、ペクチン、カラギーナン、ジェランガム、デンプン、キサンタンガム、カチオン性グアーガム、寒天、非セルロース多糖類、グルコースなどの糖類、グリセリン、プロパンジオール、ビニルポリマー、アクリル樹脂、ポリビニルアルコール、カルボキシビニルポリマー、および特に、ヒアルロン酸が含まれる)、
●ローション(これの好適なマトリックス材料には、セルロース誘導体、グリセリン、非セルロース多糖類、異なる分子量のポリエチレングリコール、およびプロパンジオールが含まれる)、
●ペーストもしくは軟膏(これの好適なペーストマトリックス材料には、グリセリン、ワセリン、パラフィン、異なる分子量のポリエチレングリコールなどが含まれる)、
●クリームもしくは発泡体(これの好適な賦形剤(例えば、発泡剤)には、ヒドロキシプロピルメチルセルロース、ゼラチン、異なる分子量のポリエチレングリコール、ドデシル硫酸ナトリウム、脂肪アルコールポリオキシエチレンエーテルスルホン酸ナトリウム、トウモロコシグルテン粉末、およびアクリルアミドが含まれる)、
●粉末エアロゾル(これの好適な賦形剤には、マンニトール、グリシン、デキストリン、デキストロース、スクロース、ラクトース、ソルビトール、およびポリソルベート、例えば、乾燥粉末吸入剤が含まれる)、ならびに/または
●経口用または吸入用の液体(エアロゾル)スプレー(これの好適な賦形剤には、ヒアルロン酸などの粘度調節剤、グルコースおよびラクトースなどの糖、乳化剤、緩衝剤、アルコール、水、保存剤、甘味料、香料などが含まれる)。
(1)本発明の化合物と、別の抗炎症剤、または副作用として炎症を引き起こすことが知られている薬剤と、医薬的に許容されるアジュバント、希釈剤、または担体とを含む、医薬製剤(この製剤は、以下「組み合わせ調製物」と称される)、および
(2)パーツキットであって、以下の構成要素、
(A)医薬的に許容されるアジュバント、希釈剤、または担体と混合された、本発明の化合物を含む医薬製剤と、
(B)医薬的に許容されるアジュバント、希釈剤、または担体と混合された、別の抗炎症剤、または副作用として炎症を引き起こすことが知られている薬剤を含む医薬製剤とを含む、パーツキットがさらに提供され、
この構成要素(A)および(B)は各々、他方と組み合わせて投与するのに好適な形態で提供される。
(i)別個の製剤(すなわち、互いに独立して)として提供され、その後、併用療法において、互いに組み合わせた使用のために一緒にされても、
(ii)併用療法において互いに組み合わせて使用するための「組み合わせパック」の別個の構成要素として一緒に包装および提示されてもよい、ということを含める。
(I)本明細書に定義される構成要素(A)および(B)のうちの1つを、
(II)その構成要素を2つの構成要素のうちの他方と組み合わせて使用するための指示書と共に含む、パーツキットがさらに提供される。
Ala−Lys−Pro−Ser−Tyr−Hyp−Hyp−Thr−Tyr−Lysの合成
Fmoc−Lys−Boc−Wang樹脂(0.3mmol/g、GLS180322−41301、GL Biochem、Shanghai,China)を反応カラムに充填した。
m/z592.65[M+2H]2+(97.89%)。
空気嚢モデル
20〜30gの重さの健康な成体の雄のC57BL/6マウスは、Nanjing Biomedicial Research Institute of Nanjing University(NBRI)から供給された。どの実験を行う前にも、マウスを標準化された条件下(22±2℃の一定温度で、12時間の明暗を交互に繰り返す)で飼育し、約1週間、標準的なマウス飼料を水と共に与えた。
急性創傷モデル
6〜8週齢の雄のC57BL/6マウスは、Changzhou Cvens Experimental Animal Co.Ltd(Changzhou,Jiangsu Province,China)から供給された。どの実験を行う前にも、マウスを標準化された条件下(22±2℃の一定温度で、12時間の明暗を交互に繰り返す)で飼育し、約1週間、標準的なマウス飼料を水と共に与えた。
At/A0×100%、
式中、A0およびAtはそれぞれ、0日目の初期領域および測定日(時間t)の創傷領域を指す。
アレルギー性皮膚炎を治療するための液体スプレー。
化合物B(上記の実施例1を参照されたい)を注射用水(WFI、TC−RO−0.25/h−2Water Treatment Systemから調製、Yangzhou Tiancheng Water Treatment Devices&Engineering Co.,Ltd.、Yangzhou,China)中に溶解した。濃度は、0.3mg/mLであった。
閉微面皰を治療するためのクリーム
化合物B(10mg、上記の実施例1を参照されたい)を最初にWFI(10g)中に溶解した。
本発明の化合物の抗酸化能力の決定
2,2−ジフェニル−1−(2,4,6−トリニトロフェニル)ヒドラジル(DPPH)アッセイを使用して、化合物Bの抗酸化能力を決定した。
本発明の化合物の安定性
(上記の実施例1および3に記載のように得た)化合物AおよびBの安定性を以下のように試験した。
化合物B/モンテルカスト包帯
最初にモンテルカストナトリウム(200mg、Arromax Pharmatech Co.,Ltd、Suzhou,China)をポリエチレングリコール400(20.0g、Sinopharm Chemical Reagent Co.Ltd)中に撹拌しながら溶解することによって、軟膏を作製した。次に、化合物B(16mg、上記の実施例1を参照されたい)をこの溶液に添加した。
化合物B/トリプシンスプレー
化合物B(30mg、上記の実施例1を参照されたい)を10mLの水中に溶解した。トリプシン(30mg、Sichuan Deebio Pharmacutical Co.Ltd.、Guanhan,Sichuan,China)を別の10mLの水中に溶解した。
吸入用の化合物B/トリプシンエアロゾル
本質的に上記の実施例9に記載のように、20mgの化合物Bおよび30mgのトリプシンから、今回はグリセロールなしで、合計99.32mLの水中にエアロゾル製剤を調製した。
風邪の研究
この研究に登録した対象は、風邪と自己診断されるウイルス感染を有した。対象は、咳、喉の痛み、および失声を含む症状を2日間示した。他の抗風邪薬は、治療前には使用されていなかった。
特発性肺線維症(IPF)モデル
実験動物および群分け:40匹の成体の雄のスプラーグドーリーラットを、7日間の適応給餌後、4つの群:偽手術群(偽)、IPFモデル群(無治療、モデル)、試験群(化合物B)、および陽性対照群(陽性対照)に分けた。
鎮咳実験−マウスにおけるアンモニア誘発性咳法。
36匹のICRマウスを、体重に従ってランダムに3つの群に分け、CMC−Na(陰性)対照群、臭化水素酸デキストロメトルファン(陽性)対照群、および化合物B(B)群とラベル付けした。各群は、各々6匹の雄および6匹の雌で12匹のマウスを含有する。
(a)前のマウスが咳をするまでにかかった時間により、次のマウスがアンモニア刺激を受けることが予定された時間(より短い時間)を決定したか、または
(b)前のマウスが咳をしなかった場合、その後のマウスはより長い時間刺激した。
EDT50=lg−1c/n
(Cは、rおよびxの合計に等しく、rは、各刺激時間群における動物の数であり、xは、刺激時間の対数であり、nは、各群における動物の数である)。lgは、10を底とする対数値である。結果を以下の表15に示す。
風邪を治療するための液体スプレー
化合物Bを注射水(WFI、TC−RO−0.25Tより/h−2水処理システム、Yangzhou Tiancheng Water Treatment Devices&Engineering Co.,Ltd.、Yangzhou,China)中に溶解した。濃度は、0.5mg/mLであった。5mLをプラスチック製の水スプレーボトルに充填した。
発熱を治療するためのエアロゾル吸入。
上記の実施例14に記載のものと同じ製剤を、1日間発熱(38.5℃超の体温)を有する研究に登録した対象に投与した。他の抗発熱薬は、治療前には使用しなかった。
レーザー手術中の手術の疼痛を緩和するための液体スプレー。
登録した対象は、顔面メラニンを除去するための格子レーザー手術の前後に、顔の半分に、水スプレーボトル中に上記の実施例14に記載のものと同じ製剤を含む1mLの液体スプレーを使用することが必要とされた。
潰瘍性大腸炎の組み合わせ治療
有効成分をメチルセルロース(2.5%)、プロパンジオール(11%)、グリセロール(11%)、および酢酸(pH制御剤、最大0.5g)と組み合わせて、5.5のpHを有するゲル前駆体をもたらすことによって、(上記のように得た)化合物Bおよびmefp−1(USUN Bio Co.、Jiangyin,China)を両方とも1mg/gの濃度で含むゲルを調製した。全ての賦形剤は、Sinopharm Chemical Reagent Co.Ltd.から得た。ゲルは、注射用水で作製された。ゲルを、使い捨ての肛門腸薬物送達系に充填した。
Claims (30)
- 医薬品としての使用のための化合物
Ala−Lys−Pro−Ser−Tyr−Hyp−Hyp−Thr−Tyr−Lys、
その位置異性体、立体異性体、または医薬的もしくは美容的に許容される塩。 - 塩の形態ではない、請求項1または請求項2に記載の使用のための化合物。
- 請求項1〜3のいずれか一項に記載の化合物、またはその医薬的もしくは美容的に許容される塩と、医薬的に許容されるアジュバント、希釈剤、または担体と、を含む、医薬製剤。
- 請求項1〜3のいずれか一項に記載の化合物、またはその医薬的もしくは美容的に許容される塩と、別の抗炎症剤と、医薬的に許容されるアジュバント、希釈剤、または担体と、を含む、医薬製剤。
- パーツキットであって、以下の構成要素、
(A)医薬的に許容されるアジュバント、希釈剤、または担体と混合された、請求項1〜3のいずれか一項に記載の化合物、またはその医薬的もしくは美容的に許容される塩を含む、医薬製剤と、
(B)医薬的に許容されるアジュバント、希釈剤、または担体と混合された、別の抗炎症剤を含む、医薬製剤と、を含み、
この構成要素(A)および(B)が各々、他方と組み合わせて投与するのに好適な形態で提供される、パーツキット。 - 炎症、炎症性障害、および/または炎症を特徴とする障害の治療における使用のための、請求項1〜3のいずれか一項に記載の化合物、またはその医薬的もしくは美容的に許容される塩、請求項4または請求項5に記載の製剤、あるいは請求項6に記載のパーツキット。
- 炎症、炎症性障害、および/または炎症を特徴とする障害の治療のための薬物の製造のための、請求項1〜3のいずれか一項に記載の化合物、またはその医薬的もしくは美容的に許容される塩、請求項4または請求項5に記載の製剤、あるいは請求項6に記載のパーツキットの使用。
- 炎症、炎症性障害、および/または炎症を特徴とする障害の治療方法であって、請求項1〜3のいずれか一項に記載の化合物、またはその医薬的もしくは美容的に許容される塩、請求項4または請求項5に記載の製剤、あるいは請求項6に記載のパーツキットを、そのような治療を必要とする患者に投与することを含む、方法。
- 前記炎症性障害が、乾癬、にきび、湿疹、および皮膚炎、鼻炎、慢性閉塞性肺疾患、および潰瘍性大腸炎から選択される、請求項7に記載の使用のための化合物、製剤、もしくはパーツキット、請求項8に記載の使用、または請求項9に記載の方法。
- 前記皮膚炎が、アトピー性皮膚炎またはステロイド依存性皮膚炎である、請求項10に記載の使用のための化合物、製剤、もしくはパーツキット、使用、または方法。
- 炎症を特徴とする前記障害が、創傷または熱傷である、請求項7に記載の使用のための化合物、製剤、もしくはパーツキット、請求項8に記載の使用、または請求項9に記載の方法。
- 前記創傷が、擦過創、引っ掻き傷、切開、裂傷、皮膚穿刺、裂離、挫傷、瘢痕もしくは水疱、または上記のうちのいずれかに関連するかゆみである、請求項12に記載の使用のための化合物、製剤、もしくはパーツキット、使用、または方法。
- 炎症を特徴とする前記病態または障害が、痔核である、請求項7に記載の使用のための化合物、製剤、もしくはパーツキット、請求項8に記載の使用、または請求項9に記載の方法。
- 炎症を特徴とする前記障害が、ウイルス感染である、請求項7に記載の使用のための化合物、製剤、もしくはパーツキット、請求項8に記載の使用、または請求項9に記載の方法。
- 前記ウイルス感染が、風邪である、請求項15に記載の使用のための化合物、製剤、もしくはパーツキット、使用、または方法。
- 特発性肺線維症の治療における使用のための、請求項1〜3のいずれか一項に記載の化合物、またはその医薬的もしくは美容的に許容される塩、請求項4または請求項5に記載の製剤、あるいは請求項6に記載のパーツキット。
- 特発性肺線維症の治療のための薬物の製造のための、請求項1〜3のいずれか一項に記載の化合物、またはその医薬的もしくは美容的に許容される塩、請求項4または請求項5に記載の製剤、あるいは請求項6に記載のパーツキットの使用。
- 特発性肺線維症の治療方法であって、請求項1〜3のいずれか一項に記載の化合物、またはその医薬的もしくは美容的に許容される塩、請求項4または請求項5に記載の製剤、あるいは請求項6に記載のパーツキットを、そのような治療を必要とする患者に投与することを含む、方法。
- 製剤またはパーツキットで提示される前記化合物(複数可)またはその塩が、局所製剤の形態で局所投与される、請求項1〜19のいずれか一項に記載の化合物、製剤、もしくはパーツキット、使用、または方法。
- 前記投与が、粘膜表面への直接局所投与である、請求項20に記載の化合物、製剤、もしくはパーツキット、使用、または方法。
- 前記投与が、肺への直接局所投与である、(請求項1〜10または17〜19のいずれか一項に従属する)請求項21に記載の化合物、製剤、もしくはパーツキット、使用、または方法。
- 前記投与が、前記皮膚への直接局所投与である、(請求項1〜16のいずれか一項に従属する)請求項20に記載の化合物、製剤、もしくはパーツキット、使用、または方法。
- 前記他の抗炎症剤が、モンテルカストまたはその医薬的に許容される塩であり、前記病態が、創傷、熱傷、または痔核である、(請求項5〜14のいずれか一項に従属する)請求項20、21、または23のいずれか一項に記載の製剤もしくはパーツキット、使用、または方法。
- 前記他の抗炎症剤が、モンテルカストまたはその医薬的に許容される塩であり、前記病態が、慢性閉塞性肺疾患または特発性肺線維症である、(請求項5〜10、13、または17〜19のいずれか一項に従属する)請求項20〜22のいずれか一項に記載の製剤もしくはパーツキット、使用、または方法。
- 前記他の抗炎症剤が、mefp−1であり、前記病態が、潰瘍性大腸炎である、(請求項5〜10のいずれか一項に従属する)請求項20〜22のいずれか一項に記載の製剤もしくはパーツキット、使用、または方法。
- 前記他の抗炎症剤が、トリプシンであり、炎症を特徴とする前記病態が、ウイルス感染である、(請求項5〜9、15、または16のいずれか一項に従属する)請求項20または請求項21に記載の製剤もしくはパーツキット、使用、または方法。
- 前記ウイルス感染が、風邪である、請求項27に記載の製剤もしくはパーツキット、使用、または方法。
- 請求項1〜3のいずれか一項に記載の化合物を、前記1つ以上のアジュバント、希釈剤、または担体と関連付けることを含む、請求項4〜28のいずれか一項に記載の医薬製剤の調製のためのプロセス。
- 前記パーツキットの構成要素(A)を、前記パーツキットの構成要素(B)と関連付けることを含む、請求項5〜28のいずれか一項に記載のパーツキットの調製のためのプロセス。
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MA54707A (fr) * | 2019-01-10 | 2021-11-17 | Jiangyin Mucocare Pharmaceutical Co Ltd | Nouvelles formulations contenant des antagonistes des récepteurs des leucotriènes |
MX2022003057A (es) * | 2019-09-14 | 2022-06-16 | Jiangyin Usun Pharmaceutical Co Ltd | Nuevos peptidos. |
TW202133882A (zh) * | 2019-12-02 | 2021-09-16 | 大陸商江陰貝瑞森生化技術有限公司 | 肽與多醣的新共軛物 |
US20230372324A1 (en) * | 2020-10-13 | 2023-11-23 | Diomed Developments Ltd. | Gel formulations comprising montelukast |
US20240165247A1 (en) * | 2021-03-17 | 2024-05-23 | Jiangyin Usun Pharmaceutical Co., Ltd. | New peptide conjugates |
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