摘要
目的建立高剂量布洛芬凝胶缓释片的体外释放方法,用于评价自制制剂与参比制剂体外释放一致性。方法采用高效液相色谱法进行释放测定,并考察不同释放条件对药物释放的影响。结果释放装置、桨转速和释放介质对高剂量布洛芬亲水凝胶缓释片的释放有较大影响,最终释放条件确定为桨法-固定篮装置,桨速为150rpm,900m L pH 7.2磷酸缓冲液作为释放介质。结论该高效液相色谱法科学可靠,桨法-固定篮装置可避免凝胶缓释片漂浮与粘壁现象,并使缓释片处于水流动力学较强的位置,该方法作为区分性释放条件较为合理。
OBJECTIVE Establish a method for in vitro release of high-dose ibuprofen gel sustained-release tablets, in order to evaluate the in vitro release of homemade preparation and reference preparation. METHODS Apply HPLC method to assay drug release. Investigate the effect of different release conditions on drug re- lease. RESULTS The release device, the paddle speed and mediums had a great impact on the release of high-dose ibuprofen hydrophilic gel sustained-release tablets. The final release was determined as paddle-stationary device with a paddle speed of 150rpm,900mL pH 7.2 phosphoric acid buffer as release medium. CONCLUSION The HPLC method is scientific and reliable. The paddle-stationary device can avoid the gel sustained-release tablets float and sticky wall, and make sustained-release tablet in the position where the hydrodynamics is stronger. This method is rea- sonable as the distinguishing release condition.
出处
《海峡药学》
2017年第5期46-49,共4页
Strait Pharmaceutical Journal
关键词
高剂量
布洛芬
亲水凝胶缓释材料
释放方法
桨法-固定篮
High dose
Ibuprofen
Hydrophilic gel sustained-release materials
Release methods
Paddle-stationary
