替米沙坦氨氯地平片处方研究及溶出行为考察  

Study on formulation and dissolution behavior of Telmisartan and Amlodipine Tablets

作　　者：徐斌 崔萍 丁逸梅 周卫[3] XU Bin;CUI Ping;DING Yimei;ZHOU Wei(Jiangsu Province Institute Limited Corporation of Materia Medica,Nanjing 210009,China;School of Pharmaceutical Sciences,Nanjing University of Technology,Nanjing 210009,China;China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]江苏省药物研究所有限公司,江苏南京210009 [2]南京工业大学药学院,江苏南京210009 [3]中国药科大学,江苏南京210009

出　　处：《药学研究》2021年第12期794-798,830,共6页Journal of Pharmaceutical Research

摘　　要：目的研究替米沙坦氨氯地平片最佳处方和制备工艺,以期得到体外溶出行为与参比制剂一致的复方制剂。方法以自制片和参比制剂在pH 7.5缓冲溶液中溶出曲线的相似因子(f_(2))为主要考察指标,采用正交设计试验进行处方优化,优化处方的制剂与参比制剂分别在4种不同溶出介质中进行溶出行为比较,用相似因子法进行评价。结果4种介质中的f_(2)值均大于50,说明按优化得到的处方制备的替米沙坦氨氯地平片与参比制剂体外溶出行为相似。结论制备的替米沙坦氨氯地平片处方合理,工艺可行。Objective To study the optimal formulation and preparation technology of Telmisartan and Amlodipine Tablets and obtain a compound preparation with the same dissolution behavior in vitro as the reference preparation.Methods Taking the similarity factor(f_(2))as the main index,the dissolution profiles of the tablets and the reference preparation in pH 7.5 buffer solution were compared.The formulation was optimized by orthogonal experiment design.The dissolution behaviors of the optimized preparation and the reference preparation in four different dissolution media were compared respectively,and evaluated by the similarity factor.Results The values of f_(2)in the four media were greater than 50,indicating that the in vitro dissolution behavior of telmisartan and amlodipine tablets prepared according to the optimized formulation was similar to that of the reference preparation.Conclusion The formulation composition of Telmisartan and Amlodipine Tablets was rational,and the preparation technology was feasible.

关 键 词：替米沙坦氨氯地平片 双层片 处方优化 正交设计 溶出曲线 

分 类 号：R943[医药卫生—药剂学]