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
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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f_2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。
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 K100 LV and HPMC K4 M 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 f_2 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.
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 K100 LV and HPMC K4 M 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 f_2 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.
引文
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[2]SAMUEL K.Advances in psychotropic formulations[J].Prog Neuro-Psychopharmacol Biol Psychiatry,2006,30(6):996-1006.
[3]Ubaldo Conte.Tablets with controlled-rate release of active substances:United states,5422123[P].1995-6-6.
[4]崔福德,陆彬.药剂学[M].第5版.北京:人民卫生出版社,2003.
[5]中国药典.四部[S].2015:121-123.