普卢利沙星胶囊处方优选及稳定性研究

筛选普卢利沙星胶囊的最佳处方、工艺,并考察其成品的稳定性。以丙二醇、低取代羟丙基纤维素（L-HPC）、粘合剂（2%K-30稀乙醇溶液和8%淀粉浆）处方用量为考察因素进行正交试验,以溶出度、流动性、含量均匀度等为成品质量考察指标进行综合评价;在光照、高温、高湿条件下对成品进行稳定性考察。最佳处方组成为丙二醇8g、低取代羟丙基纤维素（L-HPC）5g、滑石粉1g、乳糖20g、2%K-30稀乙醇溶液适量,采用制粒工艺制备;所得成品质量稳定。优选的普卢利沙星胶囊处方、工艺合理,由其制备的成品溶出度、含量均匀度、稳定性等均达《中国药典》要求。

Formulation Optimization and Stability Study of Prulifloxacin Capsules

The orthogonal experiments were performed with the formula quantity of propanediol,low substit-uted hydroxypropyl cellulose（L-HPC） and binder （2%K-30 dilute ethanol solution and 8% starch plasm） as the determination factors,the comprehensive evaluation was conducted with dissolution rate,flowability,content uniformity and so on as the quality determination index of finished preparation;The stability of the finished preparation was determined under illumination,high temperature and high moisture.The best formulation was composed of the following, propanediol 8g, L-HPC 5g, talc powder 1g, lactose 20g, appropriate amount of 2%K-30 dilute ethanol solution, which was prepared by granulating process; The resulted capsule is stable in quality. The optimized formulation and technics of prulifloxacin capsules were reasonable and the dissolution,content uniformity and stability of the finished preparation from which were in conformity with China pharmacopoeia.