利福平海藻酸钠微球栓塞剂的体外释放性质研究-药物分析专业论文 word格式.docxVIP

这种结构有利于释放介质的渗入从而将药物溶解释放出来；含药量上，高剂量组微球的含药量符合标示量，但低剂量组和中剂量组微球的含药量与标示量相差较大；不同浓度、体积的释放介质和摇床转速对利福平海藻酸钠微球的释放有所影响，但总体还是表现出微球的药物缓释性能；利福平在释放介质中不稳定，易降解，在进行释放试验结果分析时应考虑。关键词海藻酸钠微球栓塞剂体外释放稳定性AbstractObjective:Studyontherifampicinsodiumalginatemicrosphereembolizationagentinvitroreleaseindifferentconditionsandtheagent’sdrugcontent,stability,degradationtomakepreliminaryevaluationontheagentandprovidereferencefortheclinicaltests andapplications.Methods:To observe the surface and the inner structure of the alginate microsphereembolization agentbyscanningelectronicmicroscope(SEM).Thedrugcontent,stabilityanddegradationwereanalyzedbyHighPerformanceLiquidChromatography(HPLC)；PlacedtherifampicinsodiumalginatemicrospheresinreleasemediumofdifferentconcentrationsofBSAanddifferentvolumeandindifferentrotationspeedtoobserveandstudytheagentsreleasebehavior；Besides,wealsoresearchontheagentdegradationinthereleasemedium.Results：TheresultsofSEMshowthatthealginatemicrosphereembolizationagentis roughandhasirregularprotrusionsinitssurfaceandlooseandporousinitsinternalstructure.TheoptimizationresultofHPLCistoadjusttheproportionofmobilephasetomethanol：acetonitrile：0.075mol/Lpotassiumdihydrogenphosphate：1.0mol/Lcitricacid（30:32:36:4）,columntemperature35℃.The test result of drug content shows that the drug content of low-dosage（100±10mg/g）、mid-dosage（200±10mg/g）andhigh-dosage（400±10mg/g）agentare178.7024±9.0310mg/g、282.8304±5.3136mg/g、387.6569±15.5793mg/grespectively。Thetestresultofinvitroreleaseshowsthatmaximumcumulative releaseincreaseswiththeincreaseoftheBSAconcentrationandthevolumeofreleasemediumandtherotationspeed,butthedifferenceofmaximumcumulativereleasein10mLreleasemediumandin30mLand50mLreleasemediumisgreat.RifampicinreferencesubstancehasthesamedegradationinreleasemediumwhichhasthedifferentBSAconcentrationandindifferentrotationspeed.Thedegradationspeedinfluencedbythevolumeof releasemedium,itaccelerateswiththevolumeincrease.Conclusion:SEMshowsthattheroughsurfaceandtheinternalporestructureofthemicropa