论文部分内容阅读
目的制备秋水仙碱双层片,考察片芯组分对体外释药行为的影响,对片芯处方进行优化。方法采用相似因子法评价释药曲线的相似性,经单因素考察确定影响体外释药行为的主要因素,利用中心复合设计优化片芯处方。结果片芯缓释层中HPMCk15、PEO700对秋水仙碱双层片的体外释药行为有显著影响。依据最优处方制备的控释片在1～12h内呈良好的缓释释放特征,12h累积释药率达到90%以上。结论本方法适用于秋水仙碱双层片的处方优选。
OBJECTIVE To prepare colchicine bilayer tablets and investigate the influence of core components on drug release in vitro and to optimize tablet cores. Methods Similarity factor method was used to evaluate the similarity of drug release curves. The single factor was used to determine the main factors influencing the drug release behavior in vitro. The central composite design was used to optimize the core tablet prescription. Results HPMCk15 and PEO700 in sustained-release tablets had a significant effect on the in vitro release behavior of colchicine bilayer tablets. The controlled release tablets prepared according to the optimal prescription showed good sustained release characteristics within 1 ~ 12h, and the cumulative drug release rate reached more than 90% after 12h. Conclusion This method is suitable for the prescription of colchicine bilayer tablets.