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四乙酰基葛根素固体自微乳化双层片的研究
引用本文:谢欢,周伟,刘姹,杨大坚.四乙酰基葛根素固体自微乳化双层片的研究[J].中国新药杂志,2011(9).
作者姓名:谢欢  周伟  刘姹  杨大坚
作者单位:香港理工大学现代中药研究所暨深圳市中药药学及分子药理学研究重点实验室;
基金项目:深圳市深港创新圈专项资助计划(SG200710190095A)
摘    要:目的:探索固体自微乳化释药系统,制备四乙酰基葛根素固体自微乳化双层片。方法:考察各吸附材料对自微乳化液的吸附能力;以片剂外观、硬度、崩解时限等为指标筛选速释层处方;采用相似因子(f2)法评价双层片释药曲线的相似性,通过单因素考察,确定影响药物释放的主要因素;利用中心复合设计法对双层片处方进行优化,以HPMC K100LV和PEO400用量的各水平分别进行多元线性回归和二项式方程拟合,用效应面法预测最佳处方。结果:速释层的最佳处方为10%四乙酰基葛根素,30%自微乳化液,15%微粉硅胶,15%微晶纤维素,30%交联聚维酮,粘合剂为20%淀粉浆。缓释层中HPMC K100LV用量是影响药物释放的主要因素。中心复合设计优化处方的体外释放度预测值与实验值很接近。结论:中心复合设计法优化的固体自乳化双层片处方良好,双层片体外释放度达到了设计要求。

关 键 词:四乙酰基葛根素  固体自微乳化  双层片  中心复合设计  

Preparation of bi-layered solid self-microemulsifying tablets of tetra-acetylated puerarin
XIE Huan,ZHOU Wei,LIU Cha,YANG Da-jian.Preparation of bi-layered solid self-microemulsifying tablets of tetra-acetylated puerarin[J].Chinese Journal of New Drugs,2011(9).
Authors:XIE Huan  ZHOU Wei  LIU Cha  YANG Da-jian
Institution:XIE Huan,ZHOU Wei,LIU Cha,YANG Da-jian(Hong Kong Polytechnic University Institute of Mordern Chinese Medicine & State Key Laboratory of Chinese Medicine and Molecular Pharmacology,Shenzhen 518057,China)
Abstract:Objective:To investigate solid self-microemulsifying drug delivery systems and prepare bi-layered solid self-microemulsifying tablets of tetra-acetylated puerarin.Methods:The adsorption capacity of different absorbents on microemulsion was evaluated.The formulation of rapid-release layer was selected according to appearance,hardness,friability and disintegration,etc.The similarity of the drug release curve was evaluated by similarity factor method(f2).The formulation was developed based on a single-factor t...
Keywords:tetra-acetylated puerarin  solid self-microemulsifying drug delivery systems  bi-layered tablets  central composite design  
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