亲水凝胶骨架材料制备盐酸帕罗西汀缓释片的可行性研究

Feasibility Study of Paroxetine Hydrochloride Extended-release Tablets Prepared with Gel-forming Matrix Material

关键词:  亲水凝胶骨架材料  干法制粒  溶出曲线相似性  盐酸帕罗西汀缓释片  稳定性

Key words:  hydrophilic gel-forming matrix materials  dry granulation  dissolution of the similarity  Paroxetine Hydrochloride Extended-release tablets  stability

摘要:

目的 采用亲水凝胶骨架材料制备盐酸帕罗西汀缓释片，并对其质量进行评价。方法 采用亲水凝胶骨架材料HPMC K100LV和K4M联用，通过干法制粒工艺制备盐酸帕罗西汀骨架片芯，然后通过肠溶薄膜包衣液对盐酸帕罗西汀骨架片芯进行包衣，获得盐酸帕罗西汀缓释片；以溶出曲线相似性f₂值作为评价指标，通过正交设计进行处方优化，用高效液相色谱法进行含量和杂质检测，通过加速和长期试验考察片剂稳定性。结果 以该方法制备的盐酸帕罗西汀缓释片质量稳定，具有与原研制剂一致的溶出特征。结论 该方法制备盐酸帕罗西汀缓释片具有可行性。

Abstract:

OBJECTIVE To prepare Paroxetine Hydrochloride Extended-release tablets by hydrophilic gel-forming matrix materials and assess the quality. METHODS Combined with two types of hydrophilic gel-forming matrix material of HPMC K100LV and HPMC K4M to prepare Paroxetine Hydrochloride Extended-release tablets. Paroxetine Hydrochloride Extended-release tablets were manufactured by the dry granulation process and then coated with enteric coating suspension. The formulations were optimized by orthogonal experiment design utilizing dissolution similarity f₂ as an evaluation index. The drug content and impurity were analyzed by HPLC. The stability study was conducted under accelerated and long term conditions. RESULTS The optimized formulation of Paroxetine Hydrochloride Extended-release tablets showed acceptable quality and stability and similar dissolution profiles with the brand product. CONCLUSION This method to prepare Paroxetine Hydrochloride Extended-release tablets is feasible.