四氢姜黄素纳米乳的制备与体外质量评价.docxVIP

四氢姜黄素纳米乳的制备与体外质量评价

【摘要】目的：筛选合适纳米乳处方并制备四氢姜黄素纳米乳，对制得的四氢姜黄素纳米乳进行体外质量评价。方法：比较四氢姜黄素在不同油相中溶解度筛选合适油相，运用转相法制备纳米乳并绘制伪三元相图拟定纳米乳处方，借助紫外分光光度法对所制纳米乳进行含量测定，并通过测量粒径、电位、体外释放度等对其进行体外质量评价。结果：实验测得溶解度最大的油相为MCT（3.33mg/mL），利用伪三元相图筛选出纳米乳的较佳处方为纯化水66.6%，MCT8.3%，吐温8016.1%，司盘803.8%，PEG4005.0%。所建立紫外分光光度法测得四氢姜黄素在320nm波长处吸光度最大，其标准曲线方程为y=0.0886x-0.0206，在3.192~8.512mg/mL范围内呈线性。所制得四氢姜黄素纳米乳澄清透明，为O/W型，粒径71.8nm，PDI为0.206，电位-4.30mV，pH值5.39，包封率96.78%，含量6.28mg/mL，24小时体外累积释放百分率83.18%，体外释放规律符合一级动力学方程，稳定性实验结果符合规定，稳定性常数KE1.97%。结论：本研究制备的四氢姜黄素纳米乳质量评价结果优良，制备方式简单可靠。

【关键词】四氢姜黄素；伪三元相图；纳米乳；质量评价

Preparationandinvitroqualityevaluationoftetrahydrocurcuminnanoemulsions

[Abstract]Thepurposeofthisstudywastoscreensuitablenanoemulsionprescriptionsandpreparetetrahydrocurcuminnanoemulsions,andtoevaluatethequalityofthedrug-loadednanoemulsionsinvitro.Firstly,thesolubilityoftetrahydrocurcuminindifferentoilphaseswascomparedandtheappropriateoilphasewasselected.Then,thenanoemulsionwaspreparedbyphasetranspection,andapseudoternaryphasediagramwasdrawntocomparetheemulsionareasizeofdifferentprescriptionstoformulatethenanoemulsionprescription.Finally,theinvitroqualitywasevaluatedbymeasuringparticlesize,potential,invitrorelease,drugcontent,etc.TheoilphasewiththelargestsolubilitymeasuredbytheexperimentwasMCT(3.33mg/mL),andthebestprescriptionsforscreeningnanoemulsionbypseudoternaryphasediagramwerepurifiedwater66.6%,MCT8.3%,Tween8016.1%,Sipan803.8%,PEG4005.0%.Tetrahydrocurcuminhadthelargestabsorbanceatawavelengthof320nm.Thelinearregressionequationisy=0.0886x-0.0206,R2is0.9991,andthelinearrangeis3.192~8.512g/mL.Theaveragedosingrecoverywas100.43%,thestabilityRSD0.23%,theprecisionRSD0.23%,andtherepeatabilityRSD0.38%.Thetetrahydrocurcuminnanoemulsionwasclearandtransparent,withO/Wtype,particlesize71.8nm,PDIof0.206,potential-4.30mV,pHva