非洛地平缓释片的制备及体外释放行为研究  

Preparation and in vitro release behaviors of felodipine sustained-release tablets

作　　者：王登才 文瑾[3] 杨海宁 汪志强 张宇佳[2] 谭晓川 罗四海 方夏琴 郑稳生 WANG Deng-cai;WEN Jin;YANG Hai-ning;WANG Zhi-qiang;ZHANG Yu-jia;TAN Xiao-chuan;LUO Si-hai;FANG Xia-qin(Anhui University of Chinese Medicine,Hefei 230012;Institute of Materia Medica,Chinese Academy of Medical Sciences & Peking Union Medical College,Beijing Key Laboratory of Drug Delivery Technology and Novel Formulation,Beijing 100050;Chinese Pharmaceutical Association,Beijing 100022)

机构地区：[1]安徽中医药大学,合肥230012 [2]北京协和医学院中国医学科学院药物研究所药物传输技术及新型制剂北京市重点实验室,北京100050 [3]中国药学会,北京100022

出　　处：《中南药学》2019年第3期338-342,共5页Central South Pharmacy

基　　金：十三五国家"重大新药创制"科技重大专项资助(No.2017ZX09101001-005-002);中国医学科学院医学与健康科技创新工程(No.2017-I2M-1-011)

摘　　要：目的制备非洛地平缓释片,并对其进行体外释放行为研究。方法以聚氧乙烯40氢化蓖麻油为增溶剂,羟丙基甲基纤维素(HPMC)和羟丙基纤维素(HPC)为缓释材料制备非洛地平缓释片。通过单因素对处方进行初步筛选,以正交试验筛选出最佳处方,考察自制制剂和参比制剂在不同释放介质中的释放行为,并进行f_2相似因子比较。结果选择HPC(JXF)用量为15%,HPMC(E50)用量为30%,HPMC(E10M)用量为10%时,制备的非洛地平缓释片与参比制剂在不同的释放介质中相似因子f_2均在50以上。结论自制非洛地平缓释片体外释放行为与参比制剂相似。Objective To prepare felodipine sustained-release tablets and determine its in vitro release. Methods Polyoxyethylene 40 hydrogenated castor oil was used as the solubilizing agent, and HPMC and HPC were used as the sustained-release materials to prepare felodipine sustained-release tablets. The prescriptions were screened by single factors, and the best prescriptions were screened by the orthogonal test. The release behaviors of self-made preparations and reference preparations in different release media were investigated, and f2 similar factors were compared. Results When the selected amount of HPC(JXF) was 15%, HPMC(E50) dosage was30%, and HPMC(E10 M) dosage was 10%, the similar factor f2 of the prepared felodipine sustained-release tablets and the reference preparation in different release media were above 50. Conclusion The in vitro release behaviors of self-made felodipine sustained-release tablets are similar to those of the reference preparation.

关 键 词：非洛地平缓释片 羟丙基甲基纤维素(HPMC) 羟丙基纤维素(HPC) 

分 类 号：R94[医药卫生—药剂学]