非洛地平缓释片体外多pH溶出方法建立的研究

Establishment of in Vitro Multi-pH Dissolution Method for Felodipine Sustained Release Tablets

目的建立一种模拟体内胃肠道pH的体外溶出方法。方法以非洛地平缓释片作为研究对象,考察自制片与原研参比片在不同溶出条件下的体外释放行为,并以f_2因子作为评价指标。结果在pH=1.2和pH=6.5的单一溶出介质中,自制片与参比片之间的f_2因子均小于50;以pH调节剂改变溶出过程中的介质的pH后,二者体外释放行为均符合peppas方程,f_2值为61.1。结论所建立的模拟胃肠道pH的缓释片体外溶出方法能更准确地模拟药物的释放行为,与传统的溶出方法相比,具有更高的科学性和合理性。

Objective To establish an in vitro dissolution method to stimulate the gastrointestinal pH in vivo. Methods Felodipine Sustained Release Tablets were taken as the research object to investigate the in vitro release behavior of the self-made tablets and the original tablets in different dissolution conditions,and f_2 factor was taken as the evaluation index. Results In the single dissolution medium of pH = 1. 2 and pH = 6. 5,the f_2 factor between the self-made and the reference tablets was less than 50. But after the pH of the medium in the process of dissolution was changed with the pH adjuster; the release equation of the two were both in accordance with the peppas equation,and the f_2 value was 61. 1. Conclusion The method of in vitro dissolution of simulated gastric gastrointestinal pH can simulate the release behavior of drugs more accurately,and more scientific and reasonable than traditional dissolution method.