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1、二性霉素B阴道泡腾片制备工艺探究[摘要]目的:用正交设计方法优选二性霉素B阴道泡腾片的制备工艺。方法:采用正交设计,选择干颗粒水分、制粒筛网的孔径、黏合剂的用量3个因素,每个因素安排3个水平,按L9(34)进行正交实验,用外观和稳定性2个指标的综合评分确定制备工艺条件。按选定的工艺制备3批样品,考察各项质量指标和加速试验稳定性,并与上市品对比。结果:选择本品的制备工艺如下:称取碳酸氢钠90g,加入淀粉27g,以10%淀粉浆制软材,40目筛制粒,干燥至水分1%,整粒,备用;称取酒石酸90g,硼酸78g,淀粉27g,混匀,加入10%淀粉
2、浆制软材,40目筛制粒,干燥至水分1%,整粒,备用。将二性霉素B2.5g,PEG60006g混合均匀,与上述两种颗粒混匀压片,即得。制得的样品具有较好的外观,各项质量指标合格,加速试验结果表明稳定性较好,与上市品相当。结论:本研究确定的处方工艺可用于制备二性霉素B阴道泡腾片。[关键词]二性霉素B;阴道泡腾片;制备;稳定性[中图分类号]R943[文献标识码]C[文章编号]1674-4721(2010)06(c)-125-03PreparationprocessresearchofamphotericinBvaginalefferves
3、centtabletsFUXuemeng1,DONGYan2,ZHUANGRangxiao39(1.HangzhouGuoguangPharmaceuticalCo,Ltd,ZhejiangProvince,Hangzhou310018,China;2.People’sHospitalofChangxingCounty,ZhejiangProvince,Changxing313100,China;3.6thPeople’sHospitalHangzhouCityZhejiangprovinceHangzhou310014,China
4、)[Abstract]Objective:SeektheoptimumtechniquetoprepareamphotericinBvaginaleffervescenttabletsbyorthogonaltest.Methods:Theinfluencingfactorssuchasthemoistureofdriedgaranules,theapertureofgranulatingsift,theconsumptionofbinderwerestudiedandeachwasarranged3levelsaccordingt
5、oL9(34)orthogonaltable.Thecomprehesivescoreofthetwoindexes,appearenceandstability,wasusedtoassessthefigurationcharacterofatechnique.Theselectedtechniquewasvalidatedbypreparing3batchsofamphotericinBvaginaleffervescenttablets,thuscheckingtheirqualityandstabilityviaaccele
6、ratedexperimentsandcomparingwiththesameproductfromthemarkettreatedatthesameway.Results:Theadvisabletechniqueisfollowing:take9NaHCO390g,starch27g,mixevenlywith10%starchpaster,makegranulesby40-meshedsift,thendryuntilthemoisturereach1%andsiftagain,standby;taketartaricacid
7、90g,boricacid78gandstarch27g,mixevenlywith10%starchpaster,makegranulesby40-meshedsift,thendryuntilthemoisturereach1%,andsiftagain;finallyblendamphotericinB2.5gandPEG60006g,thenmixwiththeformergranulesandtablet.Theproducstwithsatisfactoryappearancescanmeettherelevantnor
8、m.Theirstabilitywerealsoacceptedthroughacceleratedexperimentsaftercomparedwiththesamemarketedproduct.Conclusion:These
