RU2011107878A - Гели на основе гиалуроновой кислоты, включающие обезболивающие агенты - Google Patents
Гели на основе гиалуроновой кислоты, включающие обезболивающие агенты Download PDFInfo
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Abstract
1. Способ получения композиции наполнителя мягких тканей, включающий следующие стадии: ! получение компонента ГК (гиалуроновой кислоты), перекрестно-сшитого с помощью по меньшей мере одного перекрестно-сшивающего агента, выбранного из группы, состоящей из 1,4-бутандиолдиглицидильного эфира (БДДЭ), 1,4-бис(2,3-эпоксипропокси)бутана, 1,4-бисглицидилоксибутана, 1,2-бис(2,3-эпоксипропокси)этилена, 1-(2,3-эпоксипропил)-2,3-эпоксициклогексана, 1,4-бутандиолдиглицидильного эфира или их комбинаций; ! доведение рН указанного компонента ГК до рН больше приблизительно 7,2; и ! добавление раствора, содержащего по меньшей мере один обезболивающий агент, к указанному компоненту ГК, имеющему указанный доведенный рН, с получением указанной композиции наполнителя мягких тканей. ! 2. Способ по п.1, где указанная композиция наполнителя мягких тканей является когезионной. ! 3. Способ по п.1, где указанный по меньшей мере один обезболивающий агент представляет собой лидокаин. ! 4. Способ по п.1, где указанную композицию наполнителя мягких тканей стерилизуют путем автоклавирования с образованием стерилизованной композиции наполнителя на основе ГК, и где указанная стерилизованная композиция стабильна при температуре окружающей среды в течение по меньшей мере 6 месяцев. ! 5. Способ по п.1 где указанный доведенный рН составляет больше чем приблизительно 7,5. ! 6. Способ по п.1, дополнительно включающий стадию гомогенизации компонента ГК во время или после стадии добавления указанного раствора, содержащего указанный обезболивающий агент. ! 7. Способ по п.1, где на указанной стадии гомогенизации указанную композицию подвергают смешиванию с контролируемым
Claims (13)
1. Способ получения композиции наполнителя мягких тканей, включающий следующие стадии:
получение компонента ГК (гиалуроновой кислоты), перекрестно-сшитого с помощью по меньшей мере одного перекрестно-сшивающего агента, выбранного из группы, состоящей из 1,4-бутандиолдиглицидильного эфира (БДДЭ), 1,4-бис(2,3-эпоксипропокси)бутана, 1,4-бисглицидилоксибутана, 1,2-бис(2,3-эпоксипропокси)этилена, 1-(2,3-эпоксипропил)-2,3-эпоксициклогексана, 1,4-бутандиолдиглицидильного эфира или их комбинаций;
доведение рН указанного компонента ГК до рН больше приблизительно 7,2; и
добавление раствора, содержащего по меньшей мере один обезболивающий агент, к указанному компоненту ГК, имеющему указанный доведенный рН, с получением указанной композиции наполнителя мягких тканей.
2. Способ по п.1, где указанная композиция наполнителя мягких тканей является когезионной.
3. Способ по п.1, где указанный по меньшей мере один обезболивающий агент представляет собой лидокаин.
4. Способ по п.1, где указанную композицию наполнителя мягких тканей стерилизуют путем автоклавирования с образованием стерилизованной композиции наполнителя на основе ГК, и где указанная стерилизованная композиция стабильна при температуре окружающей среды в течение по меньшей мере 6 месяцев.
5. Способ по п.1 где указанный доведенный рН составляет больше чем приблизительно 7,5.
6. Способ по п.1, дополнительно включающий стадию гомогенизации компонента ГК во время или после стадии добавления указанного раствора, содержащего указанный обезболивающий агент.
7. Способ по п.1, где на указанной стадии гомогенизации указанную композицию подвергают смешиванию с контролируемым усилием сдвига.
8. Способ по п.1, где на указанной стадии получения компонента ГК получают сухое не сшитое перекрестно вещество NaГК и гидратируют указанное сухое не сшитое перекрестно вещество NaГК в щелочном растворе с получением щелочного не сшитого перекрестно геля NaГК.
9. Способ по п.8, где указанный щелочной не сшитый перекрестно гель NaГК имеет рН больше чем приблизительно 8,0.
10. Способ по п.9, где указанный щелочной не сшитый перекрестно гель NaГК имеет рН больше чем приблизительно 10.
11. Способ по п.1, где указанный компонент ГК содержит высокомолекулярный компонент ГК и низкомолекулярный компонент.
12. Способ по п.11, где указанный высокомолекулярный компонент ГК имеет молекулярную массу по меньшей мере приблизительно 1 миллион Да.
13. Способ получения когезионной композиции наполнителя на основе ГК, включающий следующие стадии:
получение сухого не сшитого перекрестно вещества NaГК и гидратирования указанного сухого не сшитого перекрестно вещества NaГК в щелочном растворе с получением щелочного не сшитого перекрестно геля NaГК;
перекрестное сшивание указанного не сшитого перекрестно геля NaГК с БДДЭ с образованием перекрестно-сшитой щелочной композиции ГК, имеющей рН больше приблизительно 7,2;
добавление раствора, содержащего лидокаин HCl, к указанному компоненту ГК, имеющему указанный доведенный рН, с получением указанной композиции наполнителя на основе ГК;
гомогенизация указанной композиции наполнителя на основе ГК, приводящая к образованию гомогенизированной композиции наполнителя на основе ГК; и
стерилизация указанной гомогенизованной композиции наполнителя на основе ГК, приводящая к образованию указанной когезионной композиции наполнителя на основе ГК,
где указанная когезионная композиция наполнителя на основе ГК обладает силой выталкивания от приблизительно 10 Н до приблизительно 13 Н при скорости выталкивания приблизительно 12,5 мм/мин и обладает вязкостью от приблизительно 5 Па·с до приблизительно 450 Па·с, при измерении при приблизительно 5 Гц.
Applications Claiming Priority (11)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US8595608P | 2008-08-04 | 2008-08-04 | |
US61/085,956 | 2008-08-04 | ||
US8793408P | 2008-08-11 | 2008-08-11 | |
US61/087,934 | 2008-08-11 | ||
US9627808P | 2008-09-11 | 2008-09-11 | |
US61/096,278 | 2008-09-11 | ||
US12/393,768 | 2009-02-26 | ||
US12/393,768 US8450475B2 (en) | 2008-08-04 | 2009-02-26 | Hyaluronic acid-based gels including lidocaine |
US12/393,884 US8357795B2 (en) | 2008-08-04 | 2009-02-26 | Hyaluronic acid-based gels including lidocaine |
US12/393,884 | 2009-02-26 | ||
PCT/IB2009/005048 WO2010015901A1 (en) | 2008-08-04 | 2009-03-02 | Hyaluronic acid-based gels including anesthetic agents |
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