JP2016153416A - 関節の処置のための注射用医薬組成物 - Google Patents
関節の処置のための注射用医薬組成物 Download PDFInfo
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- JP2016153416A JP2016153416A JP2016063344A JP2016063344A JP2016153416A JP 2016153416 A JP2016153416 A JP 2016153416A JP 2016063344 A JP2016063344 A JP 2016063344A JP 2016063344 A JP2016063344 A JP 2016063344A JP 2016153416 A JP2016153416 A JP 2016153416A
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- Prior art keywords
- xylitol
- reduce
- irritation
- injection
- injectable pharmaceutical
- 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.)
- Granted
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Abstract
Description
すなわち、本発明は以下に関する。
(1)キシリトールを有効成分として含む、関節内注射のために製剤された、関節の刺激を軽減若しくは低減するため又は更なる刺激の結果としての既存の関節の炎症の増悪を低減するための注射用医薬製剤。
(2)キシリトールが、D−キシリトールである、上記(1)に記載の注射用医薬製剤。
(3)キシリトールが、L−キシリトール又はD,L−キシリトールである、上記(1)に記載の注射用医薬製剤。
(4)キシリトールの濃度が、水中で0.5%〜10%の間である、上記(1)に記載の注射用医薬製剤。
(5)少なくとも1種のポリマーを含有する、上記(1)に記載の注射用医薬製剤。
(6)500,000ダルトンを超える分子量を有する陰イオン性ポリマーをさらに含む、非ニュートン剪断減粘性を有するよう製剤された上記(1)に記載の注射用医薬製剤。
(7)陰イオン性ポリマーが、0.01%未満の無機塩の存在下で中和されたヒアルロン酸である、上記(6)に記載の注射用医薬製剤。
(8)中和されたヒアルロン酸の濃度が、0.1%〜5%である、上記(7)に記載の注射用医薬製剤。
(9)陰イオン性ポリマーが、その塩の形態であり、製剤が、無機塩を0.01%未満で含有する、上記(6)に記載の注射用医薬製剤。
(10)いかなる水中油又は水中ワックスエマルジョンも実質的に含まない、上記(1)に記載の注射用医薬製剤。
(11)キシリトールが、等張濃度である、上記(1)に記載の注射用医薬製剤。
(12)少なくとも1種の薬学的に許容される賦形剤又は添加剤をさらに含む、上記(1)に記載の注射用医薬製剤。
(13)抗炎症剤、抗酸化剤、ビタミン、別のポリオール及びそれらの組み合わせからなる群から選択される少なくとも1種の更なる医薬剤を含む、上記(1)に記載の注射用医薬製剤。
(14)本質的にポリオール有効成分からなり、前記ポリオール有効成分がキシリトールである、上記(1)に記載の注射用医薬製剤。
(15)罹患関節組織に医薬組成物を注射することを含む関節の疾患、障害又は状態を処置する方法であって、前記医薬組成物がキシリトール及び陰イオン性ポリマーを含み、非ニュートン剪断減粘性を示す、方法。
(16)罹患関節組織に医薬組成物を注射することを含む関節の疾患、障害疾患(disorder disease)、障害又は状態を処置する方法であって、前記医薬組成物がキシリトールと、場合により少なくとも1種の第2の治療薬とを含み、前記第2の治療薬が陰イオン性ポリマー、抗炎症剤、抗酸化剤、ビタミン、第2のポリオール又はそれらの組み合わせを含む、方法。
(17)関節内注射のために製剤される注射用医薬製剤の製造におけるキシリトール及び陰イオン性ポリマーの使用であって、組成物が関節の刺激を軽減若しくは低減するため又は既存の関節の炎症の増悪を低減するために非ニュートン剪断減粘性を示す、使用。
(18)関節内注射のために製剤される注射用医薬製剤の製造におけるキシリトールと場合により少なくとも1種の第2の治療薬との使用であって、前記第2の治療薬が陰イオン性ポリマー、抗炎症剤、抗酸化剤、ビタミン、第2のポリオール又はそれらの組み合わせを含み、組成物が関節の刺激を軽減若しくは低減するため又は既存の関節の炎症の増悪を低減するために非ニュートン剪断減粘性を示す、使用。
[実施例]
ヒアルロン酸塩 1g
キシリトール 4.5g
水を加えて100gにする
pHは約7.0に調整
単回又は連続注射により使用する。
非常に粘性であるが、非ニュートン剪断減粘性特性であるため、注射が容易である。滑沢作用も有する。
キシリトール 4.5g
水を加えて100gにする
pHは約7.0に調整
単回又は連続注射により使用する。
キシリトール 4.5g
レシチンエマルジョン 1g
水を加えて100gにする
pHは約7.0に調整
単回又は連続注射により使用する。
レシチンは滑沢性を与える。
ヒアルロン酸塩 1g
キシリトール 3g
緩衝生理食塩水 0.3g
水を加えて100gにする
pHは約7.0に調整
単回又は連続注射により使用する。
キシリトール 4.5g
酢酸メチルプレドニゾロン 4g(懸濁液中)
緩衝生理食塩水 0.3g
水を加えて100gにする
pHは約7.0に調整
単回又は連続注射により使用する。
キシリトール 3.0g
ジクロフェナクナトリウム 0.3g
緩衝生理食塩水 0.3g
水を加えて100gにする
pHは約7.0に調整
単回又は連続注射により使用する。
体重2〜3kgのウサギの後足の膝関節に、先の実施例に従って、以下の表に記載された通り調製された滅菌溶液を注射した。24時間後、ウサギを屠殺して関節を取り出し、滑膜の組織学的試験を実施した。
以下の組織学的所見それぞれを、0〜3で評価した。
a.滑膜表層過形成
b.フィブリンの存在
c.炎症性浸潤
d.壊死
0.5%SLS 0.25mlを注射したことによる重篤な刺激及び炎症の徴候が見出された(表1参照)。0.5%SLS 0.25mlを含む特定の化合物を注射した場合に、滑膜損傷の軽減が見出された。
ヒト軟骨試料を得て、ヒト関節摩擦試験を、Merkher Y. et .al., (2006) Tribology Letters 22: 29 - 36に記載された通り実施した。上側のヒト軟骨試料は、およそ4mm口径を有し、下側のヒト軟骨試料は、およそ6mm口径を有していた。試料1d及び2sの2種の滑沢剤を検査した。1dは、等張性塩を含まない非ニュートン粘性プロファイル製剤中の1%ヒアルロン酸ナトリウムに対応し、2sは、等張性生理食塩水の存在下であり、それゆえニュートン粘性プロファイル製剤である1%ヒアルロン酸ナトリウムに対応している。負荷10Nを、距離4mmにわたり温度36〜37℃、速度1mm/sで加えた。
Claims (11)
- キシリトールを関節の刺激を軽減若しくは低減するため又は更なる刺激の結果としての既存の関節の炎症の増悪を低減するための有効成分として含む、哺乳動物対象における関節内注射のために製剤された、注射用医薬製剤(但し、ヒアルロン酸を有効成分とするものを除く)。
- キシリトールの濃度が、水中で0.5%〜10%の間である、請求項1に記載の注射用医薬製剤。
- 少なくとも1種のポリマーをさらに含有する、請求項1又は2に記載の注射用医薬製剤。
- 少なくとも1種のポリマーが陰イオン性ポリマーであり、非ニュートン剪断減粘性を有するように、500,000ダルトンを超える分子量を有する陰イオン性ポリマーで製剤された請求項3に記載の注射用医薬製剤。
- 関節の刺激を軽減若しくは低減するため又は更なる刺激の結果としての既存の関節の炎症の憎悪を低減するための、哺乳動物対象の関節内注射のために製剤された、請求項1〜4のいずれかに記載の注射用医薬製剤。
- いかなる水中油又は水中ワックスエマルジョンも含まない、請求項1〜5のいずれかに記載の注射用医薬製剤。
- キシリトールが、等張濃度で含まれる、請求項1〜6のいずれかに記載の注射用医薬製剤。
- 少なくとも1種の薬学的に許容される賦形剤又は添加剤をさらに含む、請求項1〜7のいずれかに記載の注射用医薬製剤。
- 抗炎症剤、抗酸化剤、ビタミン、別のポリオール及びそれらの組み合わせからなる群から選択される少なくとも1種の更なる医薬剤を含む、請求項1〜8のいずれかに記載の注射用医薬製剤。
- 0.01%未満の任意の無機塩を有する、請求項1〜9のいずれかに記載の注射用医薬製剤。
- キシリトールが関節の刺激を軽減若しくは低減するため又は更なる刺激の結果としての既存の関節の炎症の憎悪を低減するための、唯一の有効成分である、請求項1〜10のいずれかに記載の注射用医薬製剤。
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CN101669962A (zh) * | 2009-09-18 | 2010-03-17 | 杭州市第六人民医院 | 复合甘草酸氨基酸注射液及其制备方法和应用 |
IL206739A (en) | 2010-06-30 | 2016-06-30 | David Segal | An injectable drug containing silitol as an active substance |
US20140038917A1 (en) | 2011-04-19 | 2014-02-06 | Anteis S.A. | Sterile and injectable aqueous formulation for administration in the intra-articular space of an intra-articular joint |
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WO2022168968A1 (ja) * | 2021-02-05 | 2022-08-11 | 学校法人近畿大学 | 末梢神経障害の予防又は改善剤 |
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EP2588080A4 (en) | 2015-01-07 |
JP2013529679A (ja) | 2013-07-22 |
IL206739A0 (en) | 2010-12-30 |
ES2679279T3 (es) | 2018-08-23 |
CA2803257C (en) | 2019-01-08 |
IL206739A (en) | 2016-06-30 |
HUE039724T2 (hu) | 2019-02-28 |
JP6166811B2 (ja) | 2017-07-19 |
KR101842295B1 (ko) | 2018-03-27 |
US20130289131A1 (en) | 2013-10-31 |
CA2803257A1 (en) | 2012-01-05 |
US9913808B2 (en) | 2018-03-13 |
US20170112782A1 (en) | 2017-04-27 |
EP2588080A1 (en) | 2013-05-08 |
WO2012001679A1 (en) | 2012-01-05 |
EP2588080B1 (en) | 2018-05-16 |
US9707190B2 (en) | 2017-07-18 |
KR20130135731A (ko) | 2013-12-11 |
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