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1、大豆苷元固體自乳化釋藥系統(tǒng)的制備及其性質(zhì)考察廖九中1,張建2,崔升淼2**作者簡介:廖九中(1969-),男,副主任藥師,主要從事醫(yī)院藥學工作,Tel:(0755)28867178E-mail:liaoajiu@126.com;通訊作者:崔升淼(1974-),女,副教授,主要從事中藥新劑型研究,Tel:(020)39352169,E-mail:cuishengmiao@yahoo.com(1.深圳市龍崗區(qū)橫崗人民醫(yī)院,廣東深圳518115;2.廣東藥學院中藥學院,廣東 廣州 510006)摘要目的:優(yōu)化大豆苷元固體自乳化釋
2、藥系統(tǒng)的處方。方法:通過處方配伍實驗和偽三元相圖的繪制,以乳化程度和乳化時間為指標,確定乳化劑、油相和助乳化劑種類,采用星點設(shè)計-效應(yīng)面法,以粒徑與電位為指標,優(yōu)選最佳自乳化處方。以β-環(huán)糊精為吸附材料,制備大豆苷元固體自乳化釋藥系統(tǒng),并采用差示熱分析和X-射線衍射鑒別藥物在載體中的存在狀態(tài)。結(jié)果:優(yōu)化后的處方組成為:大豆苷元:吐溫-80:TranscutolP:油酸乙酯:β-環(huán)糊精(9.4:54.2:20.1:25.7:400)。DSC和X-射線分析結(jié)果顯示,藥物在載體中以無定形或分子形式存在。大豆苷元固體自乳化釋藥系統(tǒng)
3、45min溶出度達85%以上。結(jié)論:固體自乳化釋藥系統(tǒng)能夠提高大豆苷元的體外溶出度。關(guān)鍵詞大豆苷元;三元相圖;星點設(shè)計;固體自乳化中圖分類號:R943.3文獻標識碼:APreparationandcharacteristicsinvitroofSolidself-emulsifyingdrugdeliverysystemsforDaidzeinLIAOJiuzhong1,ZHANGJian2,CUISheng-miao2(1.ShenzhenLonggangDistrictHenggangPeoplesHospital,S
4、henzhen,Shenzhen5181152.ChencunHospitalOfShundeFoshan,528313,GuangdongPharmaceuticalUniversity,Guangzhou510006)Abstract:ObjectiveTooptimizetheformulationofDaidzeinSolidself-emulsifyingdrugdeliverysystems(S-SEDDS).MethodsThevariousoilsandsurfactantswerescreenedbyco
5、mpatibilitytestsandpseudo-ternaryphasediagramswiththedegreeofemulsificationandlocatedintheTomb,DongShenJiabang,deferthenextdayfocusedontheassassination.Linping,Zhejiang,1ofwhichliquorwinemasters(WuzhensaidinformationisCarpenter),whogotAfewbayonets,duetomissedfatal
6、,whennightcame9emulsifyingtime.TheoptimalformulationofSEDDSfordaidzeinwasoptimizedusingcentralcompositedesignresponsesurfacemethodologywithparticlesizeandZetapotentialasdependentvariables.TheS-SEDDSforDaidzeinwaspreparedwithβ-CD.ThestateofDaidzeinincarrierswaside
7、ntifiedbyDSCscanandX-diffraction.ResultsThebestformulationofDaidzeinS-SEDDSwasmadeupofDaidzein-Tween-80-TranscutolP-Ethyloleate-β-CD(9.4:54.2:20.1:25.7:400).TheresultsofDSCscanandX-diffractionindicatedthatthedrugwasintheamorphousstate.ThedissolutionofDaidzeinS-SED
8、DSwasmorethan85%in45min.ConclusionThedissolutionofDaidzeincouldbeenhancedbyS-SEDDS.Keywords:Daidzein;pseudo-ternaryphasediagram;centralcompositedesign;S