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1、2006,Vol.30,No.11505#实验与研究#ProgressinPharmaceuticalSciences2006年第30卷第11期第505页盐酸二甲双胍缓释片的实验研究*马成孝,蔡春萍,赵建宗(苏州东瑞制药有限公司研发部制剂所,江苏苏州215128)[摘要]目的:研制具双重控释系统的盐酸二甲双胍缓释片,探讨其片芯和包衣的优化处方及释放机制。方法:以氢化蓖麻油作为蜡质控释材料制备片芯,采用丙烯酸树脂作为半渗透性控释包衣材料,制备具双重控释系统的盐酸二甲双胍缓释片。分别以外观、硬度、流动性、可压性及释放度作为考察指标,对片芯和包衣处方进行优化筛选。结果:所制缓释片的体外释
2、放度不受释放介质和转速影响。处方9片芯表面光滑,硬度、流动性和可压性均较好,0.5、1和3小时的释放度分别为40.2%、56.8%和85.7%;处方5包衣可致片剂在5和8小时的释放度分别达50%和80%。本品可稳定释放达12小时,释放行为符合一级速度方程。结论:本品处方工艺可操作性强,释药持续稳定。[关键词]盐酸二甲双胍;双重控释系统;缓释片;释放度[中图分类号]R977115;R94419[文献标识码]A[文章编号]1001-5094(2006)11-0505-04AnExperimentalStudyonSustained-releaseTabletsofMetforminHy
3、drochloride*MACheng-xiao,CAIChun-ping,ZHAOJian-zong(DepartmentofPharmaceutics,SuzhouDawnraysPharmaceuticalCO.LTD.,Suzhou215128,China)[Abstract]Objective:Toresearchanddevelopsustained-releasetabletsofmetforminhydrochloridewitha/dualcontrolledrelease0systemandtoinvestigatetheoptimizationoftablet
4、coreandcoatingformulationsandtheirreleasingmechanism.Methods:UsinghydrogenatedcastoroilasacontrolledreleasewaxymaterialforthecoreandEudragitNE30Dasacontrolledreleasematerialforthesemipermeablecoating,thetargettabletswereprepared.Basedontheinvestigationintoappearance,hardness,fluidity,tabletabi
5、lityandreleaserateofthetablets,thecoreandcoatingformulationswerescreenedforoptimization.Results:Invitroreleaserateofthetabletswasnotaffectedbyreleasemediumandrevolution.Thecorepreparedwithformulation9wassmooth,withgoodhardness,fluidity,tabletabilityandreleaserate(40.2%,56.8%and85.7%respectivel
6、yat0.5,1and3h).Thetabletscoatedwithformulation5showedreleaseratesof50%and80%respectivelyat5and8h.Thetargettabletscouldreleasesteadilyfor12handtheirreleasebehavioragreedwithfirs-torderequation.Conclusion:Thetechnicalprocessforthetargettablets,whichshowedasteadyandsustainedrelease,iseasytooperat
7、e.[Keywords]Metforminhydrochloride;Dualcontrolledreleasesystem;Sustained-releasetablet;Releaserate盐酸二甲双胍(metforminhydrochloride,MH)是对成年糖尿病病人疗效最好,对幼年稳定型糖尿病一种双胍类口服降糖药物,用于Ò型糖尿病的治疗,病人也有一定疗效。但MH普通制剂临床服用量*[接受日期]2006-06-14通讯作者:马成孝,高级工程师,从事固体制剂
