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1、氯雷他定片溶出度测验方法的改进郑淑凤,郭伟斌,王玉,唐立超,黄剑英,李玲玲(厦门市药品检验所,福建厦门361012)摘要:目的改进氯雷他定片的溶出度测验方法,考察国内31家企业氯雷他定片的内在质量。方法根据本品的溶解吸收特性,采用生物药剂学分类系统Ⅱ类药物的两点测定法,拟定既符合氯雷他定人体吸收特点又能区分产品内在质量的1溶出度检查方法。采用浆法,以pH3.0缓冲液为溶出介质,转速为75r·min。液相色谱条件:AgilentTC-C18(4.6mm×250mm,5μm)色谱柱,流动相为乙腈-水(含0.5%二乙胺,用磷酸调pH值为3.0±0.05)(60∶40);检测波长为247
2、nm,11流速:1.0mL·min,柱温:35℃;进样量:20µL。结果氯雷他定在1.006~32.176µg·mL内呈现良好的线性关系,r=1.000,采用此法检测31家企业各若干批样品的溶出度,不合格率达74.7%,与溶出曲线考察结果一致。结论拟定的溶出试验方法更能体现药品的生物利用度,溶出液测定方法准确、重现性好、操作简单。对全国范围样品考察结果显示,方法能够有效控制产品的内在质量。关键词:氯雷他定片;溶出度;生物药剂学分类系统;高效液相色谱法中图分类号:R917.101文献标志码:B文章编号:1007-7693(2015)02-0178-04DOI:10.13748/j.
3、cnki.issn1007-7693.2015.02.012ImprovedDissolutionMethodofLoratadineTabletsZHENGShufeng,GUOWeibin,WANGYu,TANGLichao,HUANGJianying,LILingling(XiamenInstituteforDrugControl,Xiamen361012,China)ABSTRACT:OBJECTIVEToimproveatestmethodforthedissolutionofloratadinetabletstoinspectthedeterminationoflorat
4、adinetabletsfrom31factoriesinChina.METHODSAccordingtoloratadinetablets’specialityofdissolutionandabsorption,setadiscriminatingspecificationfordissolutiontesting,usingtwopointsforbiopharmaceuticsclassificationsystemⅡdrugs’assessment.Thedissolutionwasdeterminedbypaddlemethod,themediumwaspH3.0buff
5、ersolution,androtate1speedwas75r·min.ThechromatographicconditionwasAgilentTC-C18(4.6mm×250mm,5μm)column,themobilephaseconsistedofacetonitrileandwater(0.5%diethylamineadjustedtopH3.0withphosphoricacid)(60∶40),thewavelengthofUV1detectorwas247nm;theflowratewas1.0mL·min,theinjectionvolumewas20µL.
6、RESULTSThecalibrationcurvewas1linerintheconcentrationrangeof1.00632.176µg·mL,r=1.000;severalsamplesfrom31factoriesweredetectedusingthismethodandthefractiondefectivewas74.7%.CONCLUSIONTheimprovedmethodshowsmorebiologicalavailabilitythanbefore,andtheassaymethodisaccurate,highlyspecificandwidely
7、applicable.Throughtheinvestigationofsamplesfromthewholecountry,itisshownthatthemethoddevelopedcanbeapplicabletoallthesamplesandeffectivelycontroltheinternal-qualityofproduct.KEYWORDS:loratadinetablets;dissolution;biopharmaceuticsc