Parecoxib sodium freeze-dried preparation and preparation method thereof

The invention, which belongs to the technical field of medicines, particularly relates to a parecoxib sodium freeze-dried preparation and a preparation method thereof. The parecoxib sodium freeze-dried preparation provided by the invention comprises parecoxib sodium, disodium hydrogen phosphate, vit...

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Bibliographische Detailangaben
Hauptverfasser: SUN YUNBEI, CHEN YU, ZHANG KUIQIANG
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention, which belongs to the technical field of medicines, particularly relates to a parecoxib sodium freeze-dried preparation and a preparation method thereof. The parecoxib sodium freeze-dried preparation provided by the invention comprises parecoxib sodium, disodium hydrogen phosphate, vitamin E, a stabilizer, 3, 4, 5-trihydroxybenzoic acid and a pH regulator. The Vitamin E and the stabilizer are mixed for use and the 3, 4, 5-trihydroxybenzoic acid is added in the preparation process, so that generation of main impurities, especially sulfonate impurities, in parecoxib sodium is effectively inhibited; the 3, 4, 5-trihydroxybenzoic acid is added when the parecoxib sodium is dissolved due to the fact that the 3, 4, 5-trihydroxybenzoic acid is dissolved in hot water and slightly dissolved in cold water, and then cooling and filtering are conducted, so that the product redissolution clarity is not affected while the quality is guaranteed. 本发明属于医药技术领域,具体涉及一种帕瑞昔布钠冻干制剂及其制备方法。本发明提供的帕瑞昔布钠冻干制剂包括帕瑞昔布钠、磷酸氢二钠、维生素