摘要
目的:制备欧前胡素柔性脂质体凝胶(IMP-UDLs-Gel),并对其进行质量评价。方法:在单因素考察的基础上,以12 h累积透过量(Q12 h)为评价指标,采用正交试验法对IMP-UDLs-Gel处方中的卡波姆940比例、甘油比例和丙二醇比例进行考察,筛选最优处方,并对最优处方所制备的IMP-UDLs-Gel进行质量评价。结果:IMP-UDLs-Gel最优处方为卡波姆940比例1%、甘油比例15%、丙二醇比例10%。所制得的IMP-UDLs-Gel的Q12 h为(11.543±0.241)μg/cm^2;外观为乳白色、半透明状;粒径为(93.13±1.68)nm,多分散系数为0.268±0.012,Zeta电位为(-24.96±1.99)mV;pH为7.32±0.03;黏度为(45.37±1.27)g·s;稳态流量为(0.727±0.002)μg·h/cm^2,滞后时间为(4.358±0.175)h,表观渗透系数为1.392×10^-3cm/h,且具有良好的物理稳定性和光稳定性。结论:建立的制备方法稳定可行,所制备的IMP-UDLs-Gel具有良好的黏附性、稳定性和透皮性。
OBJECTIVE:To prepare Imperatorin ultradeformable liposomes gel(IMP-UDLs-Gel),and to evaluate its quality.METHODS:Based on single factor test,using 12 h accumulative penetration amount(Q12 h)as evaluation index,the proportion of carbomer 940,glycerol and propyl glycol in formulation of IMP-UDLs-Gel were investigated by orthogonal test.The optimal formulation was screened.The quality of IMP-UDLs-Gel prepared with the optimal formulation was evaluated.RESULTS:The optimal formulation of IMP-UDLs-Gel included carbomer 940 proportion of 1%,glycerol proportion of 15%and propyl glycol proportion of 10%.Q12 hof IMP-UDLs-Gel was(11.543±0.241)μg/cm^2;the appearance was milky white and translucent;the particle size was(93.13±1.68)nm,PDI was 0.268±0.012,Zeta potential was(-24.96±1.99)m V;pH was 7.32±0.03;viscosity was(45.37±1.27)g·s;steady flow was(0.727±0.002)μg·h/cm^2,lag time was(4.358±0.175)h,apparent permeability coefficient was 1.392×10^-3 cm/h,and it has good physical and optical stability.CONCLUSIONS:The preparation method is stable and feasible,and the prepared IMP-UDLs-Gel has good adhesion,stability and transdermal property.
作者
崔雪惠
陈世洪
邱金娣
班俊峰
杨楠楠
倪庆纯
潘钊言
谢清春
陈燕忠
吕竹芬
CUI Xuehui;CHEN Shihong;QIU Jindi;BAN Junfeng;YANG Nannan;NI Qingchun;PAN Zhaoyan;XIE Qingchun;CHEN Yanzhong;LYU Zhufen(Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems/New Drug R&D Center,Guangdong Pharmaceutical University,Guangzhou 510006,China;R&D Innovation Team for Controlled-release Microparticle Drug Delivery System/Guangdong Provincial Engineering Center of Topical Precision Drug Delivery System,Guangdong Pharmaceutical University,Guangzhou 510006,China;Guangzhou General Pharmaceutical Research Institute Co.,Ltd.,Guangzhou 510240,China;Xinhua College of Sun Yat-sen University,Guangzhou 510520,China)
出处
《中国药房》
CAS
北大核心
2020年第9期1074-1079,共6页
China Pharmacy
基金
广东省自然科学基金资助项目(No.2019A1515011018)
广东省研究生教育创新计划项目(No.粤教研函〔2018〕17号)。
关键词
欧前胡素
柔性脂质体
凝胶
处方优化
制备
质量评价
透皮性
Imperatorin
Ultradeformable liposomes
Gel
Formulation optimization
Preparation
Quality evaluation
Transdermal characteristics
