一种兽用地美硝唑预混剂的制备及稳定性研究 .pdf

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一种兽用地美硝唑预混剂的制备及稳定性研究

骆桂红厦门惠盈动物药业有限公司福建厦门361023

摘要以地美硝唑为主成分原料袁以聚乙二醇6000尧倍他环糊精作为主成分的助溶剂袁地美硝唑和辅料经过过筛尧混合后进行

粉碎制得地美硝唑预混剂遥该配方的组合为院质量比M渊地美硝唑冤:M渊倍他环糊精冤:M(聚乙二醇6000)=2:2:6遥研究表明地美硝

唑预混剂的溶解度良好袁溶解度可达8.0%曰按地美硝唑预混剂的质量标准要求检测袁合格遥该配方组合可以同时实现药物的饮水

和拌料给药遥在密闭条件下保存袁长期试验2年袁产品的性状和外观几乎没有改变曰地美硝唑含量从初始的100.1%下降至

97.5%袁有效成分含量下降幅度未超过地美硝唑标示量百分含量的10%遥产品质量稳定袁符合兽药典的要求遥地美硝唑预混剂的

配方合理尧生产操作简单袁产品24个月质量稳定袁有效期可暂定为24个月遥

关键词地美硝唑倍他环糊精聚乙二醇6000助溶剂稳定性有效期

文献标识码院A文章编号院1003-4331渊2024冤01-0013-03

PreparationandstabilityofonekindofDimetridazolepremixforanimals

LuoGuihong

渊XiamenHuiyingAnimalPharmaceuticalCo.Ltd,FujianXiamen361023冤

AbstractTheDimetridazolepremixwaspreparedbymixingandpulverizingthemainrawmaterialandauxiliarymaterialofDimetri鄄

dazolewithBetacyclodextrinandPolyethyleneglycol6000asco-solvents.TheformulacombinationisM(Dimetridazole):M(Betacy鄄

clodextrin):M(PolyethyleneGlycol6000)=2:2:6.Theresultsshowedthatthesolubilityofthepreparedpremixwasgood,thesolubili鄄

tywasupto8.0%,AccordingtothequalitystandardofDimetridazolepremix,qualified.Themixedfeedinganddrinkingwateradmin鄄

istrationofinsolubledrugscanberealized.After2yearsoflong-termstorage,thecharacterandappearanceoftheproductwereal鄄

mostunchanged,thecontentofDimetridazoledecreasedfrom100.1%to97.5%,thecontentofactiveingredientdidnotexceed10%

ofthelabeledcontentofDimetridazole.Productqualityisstable,inlinewiththerequirementsofveterinarypharmacopoeia.Thefor鄄

mulationofDimetridazolepremixisreasonable,theproductionoperationissimple,thequalityoftheproductisstablein24months,

andthevalidi