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Aspirin dipyridamole capsules
Author: JinLing
Tutor: HeZhongGui
School: Shenyang Pharmaceutical University
Course: Pharmacy
Keywords: Dipyridamole Aspirin Salicylic acid Centrifugal granulation Sustained-release pellets Pharmacokinetics
CLC: R94
Type: Master's thesis
Year: 2006
Downloads: 50
Quote: 0
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Abstract
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Aggrenox (the compound aspirin / dipyridamole dipyridamole sustained-release capsules) for immediate-release aspirin and sustained-release dipyridamole composition is an effective anti-platelet aggregation drugs, since the end of 1999, the U.S. FDA approved the listing, it has been listed in a number of countries. The efficacy of twice the efficacy of each of these two drugs alone. Based on the foreign market aspirin / dipyridamole and dipyridamole sustained-release capsules, taken twice a day developed aspirin dipyridamole sustained-release capsules. Established HPLC method for the determination of the content of aspirin dipyridamole dipyridamole sustained-release capsules dual dipyridamole and aspirin; UV spectrophotometry were measured aspirin dipyridamole sustained-release capsules aspirin and dipyridamole release. The Domestic centrifugal granulating equipment, a powder lamination prepared dipyridamole pellets drug loading of about 85%; optional acrylic resin water dispersion (Eudragit ? Sup> NE30D, Eudragit ? sup> L30D-55) as a coating material for the coating. The coating process factors and formulation factors on the drug release rate, the results indicate that the release of sustained release pellets coated pellets dipyridamole sustained-release effect in vitro dissolution curves show the closest a kinetic equation. In the direct powder tabletting aspirin immediate release tablet is prepared to its release rate meet the requirements. Sustained-release pellets of dipyridamole and aspirin film-coated tablets dosed into the capsule. HPLC was used in single and multiple oral aspirin dipyridamole capsules (test formulation) and dipyridamole tablets were measured at different times human plasma aspirin enteric-coated tablets (reference formulation) dipyridamole and aspirin metabolites concentration of salicylic acid. After a single oral dose of aspirin, dipyridamole sustained-release capsules double-crossover trial, the test preparation and reference preparation dipyridamole dipyridamole plasma AUC 0-t 12010.2 ± 5218.6 and 8543.7, respectively. ± 3190.4ng · h · mL -1 sup>, AUC 0-t , the relative bioavailability of dipyridamole average (108.4 ± 33.7)%. Test and reference preparations aspirin metabolite salicylic acid in plasma at the AUC 0-12 were 6632.2 ± 1559.8 and 7058.8 ± 1485.3 ng · h · mL -1 sup > AUC 0-t , the relative bioavailability of salicylic acid average (95.4 ± 18.1)%. After repeated administration of dipyridamole, and its relative bioavailability (97.22 ± 32.5)%; salicylate relative bioavailability (96.7 ± 11.7)%. The statistical test showed that the test tablets and reference bioequivalent.
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