盐酸帕罗西汀肠溶缓释片的制备及体外释放研究

摘要

Objective To prepare enteric‐coated sustained‐release tablets of paroxetine hydrochloride ,and to investigate in vitro drug release behavior .Methods The sustained‐release tablets of paroxetine hydrochloride were prepared by HPMC K100LV and HPMC K4M ,and lactose monohydrate as the filling agent .The enteric‐coated tablets were prepared by Eudragit L 30D‐55 .The release be‐havior similarity was investigated between the reference and self‐prepared tablets in release media .Similar factor f2 was used to e‐valuate the similarity of release curves .Results The in vitro release data proved that the values of f2 was more than 50 .Conclusion The release behaviors of paroxetine hydrochloride enteric‐coated sustained‐release tablets and reference tablets were similar .%目的：制备盐酸帕罗西汀肠溶缓释片，并对其体外释放度进行考察。方法采用 HPMC K100LV和 HPMC K4M 作为骨架材料，以水乳糖为填充剂制备盐酸帕罗西汀缓释片芯，再使用Eudragit L30D‐55包肠溶衣，制成盐酸帕罗西汀肠溶缓释片，并采用 f2相似因子法评价自制制剂和参比制剂在释放介质中的体外释放行为。结果体外释放度实验显示，自制制剂和参比制剂的 f 2相似因子值大于50。结论制备的盐酸帕罗西汀肠溶缓释片的释药行为与参比制剂的体外释放行为相似。