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1、茶碱缓释片制备工艺对释放度影响探究［摘要］目的:以乙基纤维素为骨架材料，以耗丙基甲基纤维素为致孔剂制成茶碱缓释骨架片，考察軽丙基甲基纤维素(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:用轻丙基甲基纤维素制备的茶碱缓释片，释放度数据较稳定;调整軽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
2、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］茶碱缓释片强丙基甲基纤维素(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)-042-03InflueneeofthepreparationcraftofTheophyllineSustainedReleaseTabletsonthedrugreleaseHUANGHaowul,LUOYuhongl,LIANGFeih
3、ua2(I.ThePeople'sHospitalofZhuhai,Zhuhai519000,China;2.TheSecondPeople'sHospitalofZhuhai,Zhuhai519000,China)[Abstract]Objective:TopreparetheTheophyllineSustainedReleaseMatrixTabletswithethylcelluloseasthematrixmaterialandhydroxypropylmethylcelluloseast
4、hepore-formingagent,investigatetherelationshipsbetweenhydroxypropylmethylcellulose(HPMC),ethylcellulose(EC)andthedrugreleaseofTheophyllineSustainedReleaseTablets,andinvestigatetheinfluenceofthepreparationcraftofTheophyllineSustainedReleaseTabletsonther
5、eleaserate・Methods:Withtheevendesignexperiment,theinvitrodrugreleaseofTheophyllineSustainedReleaseTabletswasdetermined・Results:ThedrugreleasedataofTheophyllineSustainedReleaseTabletspreparedwiththehydroxypropylmethylcellulosewerestable;thehydroxypropyl
6、methylcelluloseandtheethylcelluloseamountswereadjusted,thereleaserateofthematrixtabletspreparedbythewetlegalsystemgrainswasslowerthanthatpreparedbydrydirectcompression;thecompressionforcealsoinfluencedthereleaserateofthedrugtosomedegree.Conclusion:Thep
7、reparationcraftsuitableforproductionisfoundbytheinvestigationofpreparationcraftofTheophyllineSustainedReleaseTablets,thedrugactionsarestable,thesafetyandefficacyofTheophyllinedrugsarealsoimproved・[Keywords]TheophyllineSustainedReleaseTablets;Hydroxypro
8、pylmethylcellulose(HPMC);Ethylcellulose(EC);Drugrelease茶碱能使支气管肌肉强直，收缩减少，松弛平滑肌，但茶碱半衰期也因人治疗血药浓度范围狭窄(5~20pg/ml),清除率、而异，普通茶碱片需日服3次，夜间发作时用药影响睡眠，频繁给药后血药浓度容易出现赠谷”现象，引起头痛、恶心、失眠、抽筋及过敏等毒副作用[1],茶碱缓释片可解决这一问题。采用乙基纤维素(EC)为骨架材料，以轻丙基甲基纤维素(HPMC)为致孔剂制成茶碱
