萘普生微囊栓的制备及其质量控制

Preparation and Quality Control of Naproxen Microcapsule Suppository

目的:制备萘普生微囊栓并对其进行质量控制。方法:取萘普生微囊和混合脂肪酸甘油酯,以热熔法制成微囊栓,并按2010年版《中国药典》有关要求进行外观、重量差异、含量测定、体外释放等质量评价,并与萘普生微囊及普通栓比较体外累积释药率。结果:萘普生微囊栓的外观、重量差异、含量测定均符合《中国药典》规定。微囊栓在48h时体外累积释药率为90.87%,微囊36h达到91.02%,普通栓3h达到94.51%。结论:萘普生微囊栓制备工艺简单、质量可控,具有较好的缓释作用。

OBJECTIVE： To prepare Naproxen microcapsule suppository and to investigate quality control of it.METHODS： Naproxen microcapsule suppository was prepared with naproxen microcapsule and mixed fatty glyceride by means of hot melting process.The quality of microcapsule suppository was evaluated according to the requirements of Chinese Pharmacopeia （2010 edition） in respect of appearance,weight variation,content determination and release rate.In vitro drug release rate of Naproxen microcapsule suppository was compared with that of Naproxen microcapsule and conventional suppository.RESULTS： The appearance,weight variation and content determination of Naproxen microcapsule suppository were in line with the requirements of Chinese Pharmacopeia.Drug release rate of Naproxen microcapsule suppository was 90.87% at 48 h in vitro,that of microcapsule was 91.02% at 36 h,and that of conventional suppository was 94.51% at 3 h.CONCLUSION： The preparation process of Naproxen microcapsule suppository is simple.And it has good quality control and sustained release.