头孢拉定缓释制剂的制备及释放特征研究

摘要

目的：头孢拉定为第1代半合成头孢菌素，为了满足临床特殊用途，进行缓释片的研究。方法采用羟丙甲纤维素（HPMC）、丙烯酸树脂Ⅱ号等缓释材料制备头孢拉定缓释制剂，并考察丙烯酸树脂Ⅱ号含量、剂型、释放介质等对体外累积释放率的影响。结果头孢拉定缓释片体外释药测定结果符合缓释制剂要求。结论头孢拉定缓释片与Higuchi方程拟合较好（在PH＝1.2人工胃液中线性回归系数为0.9887，在PH＝7.4人工肠液中为0.9935），是骨架溶蚀和药物扩散的综合效应过程。%Objective Cefradine is the first generation of half synthetic cePhalosPorin. To study the cefradine sustain-release tablet for sPecific usage in the clinic. Methods Sustained-release materials,such as HPMC and Eudragit Ⅱwere adoPted to PrePare the cefra-dine sustained-release dosage forms,and the effects of acrylic resin content,dosage forms and release medium on the cumulative drug release were studied. Results The cefradine sustained-release tablets met the requirements of sustained-release. Conclusion The cefradine sustained-release tablets fit well with the Higuchi equation ( PH=1. 2,R2=0. 988 7,PH=7. 4,R2=0. 994 3 ) ,which is a comPrehensive Process of skeleton dissolution and drug diffusion.