Infusion of ciprofloxacin having reduced acid content and being stable in storage
本发明涉及一种贮藏稳定的1-环丙基-6-氟-1,4-二氢-4-氧代-7-(l-哌嗪基)-喹啉-3-羧酸(环丙氟沙星)输注液,通过将0.015-0.5g活性物质的100ml水溶液与硫酸或硫酸氢钠以等于或低于0.96Mol/1Mol活性物质的足够溶解活性物质并使溶液稳定的量混合而获得。本发明还涉及这种输注液的制备方法及其用途。根据本发明的输注液允许酸含量的减少,就相同的制备酸含量而言比其它已知溶液更为贮藏稳定,并且对比至此通常的环丙氟沙星输注液,在活性物质中能承受更高的次要组分。 The invention relates to aqueous infusion solutions of 1-cy...
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Zusammenfassung: | 本发明涉及一种贮藏稳定的1-环丙基-6-氟-1,4-二氢-4-氧代-7-(l-哌嗪基)-喹啉-3-羧酸(环丙氟沙星)输注液,通过将0.015-0.5g活性物质的100ml水溶液与硫酸或硫酸氢钠以等于或低于0.96Mol/1Mol活性物质的足够溶解活性物质并使溶液稳定的量混合而获得。本发明还涉及这种输注液的制备方法及其用途。根据本发明的输注液允许酸含量的减少,就相同的制备酸含量而言比其它已知溶液更为贮藏稳定,并且对比至此通常的环丙氟沙星输注液,在活性物质中能承受更高的次要组分。
The invention relates to aqueous infusion solutions of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-quinoline-3-carboxylic acid (ciprofloxacin) which are stable in storage and which can be obtained by mixing between 0.015 and 0.5 g of active ingredient for 100 ml of aqueous solution with sulphuric acid or sodium hydrogen sulfate in a quantity equal to or less than 0.96 mole per mole of active ingredient, sufficient for dissolving the active ingredient and stabilizing the solution. The invention also relates to methods for producing the infusions and the use thereof. The inventive infusions enable the acid content to be reduced, are more stable in storage with the same acid content than other known solutions, and enable a larger proportion of secondary components to be tolerated in the active ingredient than previous standard infusions of ciprofloxacins. |
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