氯雷他定片溶出度测验方法的改进_郑淑凤.pdf

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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，11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,androtate1speedwas75r·min.ThechromatographicconditionwasAgilentTC-C18(4.6mm×250mm,5μm)column,themobilephaseconsistedofacetonitrileandwater(0.5%diethylamineadjustedtopH3.0withphosphoricacid)(60∶40),thewavelengthofUV1detectorwas247nm;theflowratewas1.0mL·min,theinjectionvolumewas20µL.

6、RESULTSThecalibrationcurvewas1linerintheconcentrationrangeof1.00632.176µg·mL,r=1.000;severalsamplesfrom31factoriesweredetectedusingthismethodandthefractiondefectivewas74.7%.CONCLUSIONTheimprovedmethodshowsmorebiologicalavailabilitythanbefore,andtheassaymethodisaccurate,highlyspecificandwidely

7、applicable.Throughtheinvestigationofsamplesfromthewholecountry,itisshownthatthemethoddevelopedcanbeapplicabletoallthesamplesandeffectivelycontroltheinternal-qualityofproduct.KEYWORDS:loratadinetablets;dissolution;biopharmaceuticsc