茶碱缓释片的制备工艺对释放度的影响研究.docx

茶碱缓释片的制备工艺对释放度的影响研究[摘要]目的:以乙基纤维素为骨架材料以羟丙基甲基纤维素为致孔剂制成茶碱缓释骨架片考察羟丙基甲基纤维素(HPMC)、乙基纤维素(EC)与茶碱缓释片释放度的关系以及制备工艺对茶碱缓释片体外释药速度的影响。方法:均匀设计实验对茶碱缓释片进行体外释放度测定。结果:用羟丙基甲基纤维素制备的茶碱缓释片释放度数据较稳定;调整羟丙基甲基纤维素和乙基纤维素用量配比湿法制粒所得骨架片的释药速度比干法直接压片有所减慢;压片力的大小对释药速度也有一定的影响。结论:通过对茶碱缓释片制备工艺条件的考察找到了适合生产的制备工艺使药效稳定提高了茶碱用药的安全性和有效性。[关键词]茶碱缓释片;羟丙基甲基纤维素(HPMC);乙基纤维素(EC);释放度[中图分类号]R944.4[文献标识码]A[文章编号]1673-7210(2010)03(a)-042-03InfluenceofthepreparationcraftofTheophyllineSustainedReleaseTabletsonthedrugreleaseHUANGHaowu1LUOYuhong1LIANGFeihua2(1.ThePeople'sHospitalofZhuhaiZhuhai519000China;2.TheSecondPeople'sHospitalofZhuhaiZhuhai519000China)[Abstract]Objective:TopreparetheTheophyllineSustainedReleaseMatrixTabletswithethylcelluloseasthematrixmaterialandhydroxypropylmethylcelluloseasthepore-formingagentinvestigatetherelationshipsbetweenhydroxypropylmethylcellulose(HPMC)ethylcellulose(EC)andthedrugreleaseofTheophyllineSustainedReleaseTabletsandinvestigatetheinfluenceofthepreparationcraftofTheophyllineSustainedReleaseTabletsonthereleaserate.Methods:WiththeevendesignexperimenttheinvitrodrugreleaseofTheophyllineSustainedReleaseTabletswasdetermined.Results:ThedrugreleasedataofTheophyllineSustainedReleaseTabletspreparedwiththehydroxypropylmethylcellulosewerestable;thehydroxypropylmethylcelluloseandtheethylcelluloseamountswereadjustedthereleaserateofthematrixtabletspreparedbythewetlegalsystemgrainswasslowerthanthatpreparedbydrydirectcompression;thecompressionforcealsoinfluencedthereleaserateofthedrugtosomedegree.Conclusion:ThepreparationcraftsuitableforproductionisfoundbytheinvestigationofpreparationcraftofTheophyllineSustainedReleaseTabletsthedrugactionsarestablethesafetyandefficacyofTheophyllinedrugsarealsoimproved.[Keywords]TheophyllineSustainedReleas