阿维A胶囊处方筛选及稳定性研究

目的:筛选阿维A胶囊的最佳处方、工艺,并考察其成品的稳定性。方法:以可压性淀粉、乳糖、低取代羟丙基纤维素(L-HPC)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。结果:最佳处方组成为可压性淀粉20%、乳糖20%、L-HPC1%,采用制粒工艺制备;所得成品质量稳定。结论:优选的阿维A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 Acitretin Capsule

OBJECTIVE:To optimize the best formulation and process of acitretin capsule and to study the stability of its finished preparation.METHODS:The orthogonal experiment was conducted with the formula quantity of amylum pregelaˉtinisatum,lactose and low-substituted hydroxypropyl cellulose(L-HPC)as the determination factors,the comprehensive eˉvaluation 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.RESULTS:The best formulation was composed of the following,amylum pregelatinisatum20%,lactose20%,L-HPC1%,which was prepared by granulating process;The finished preparation was stable in quality.CONCLUSION:The optimized formulation and technics of acitretin capsule were reasonable and the dissolution,content uniformity and stability of the finished preparation from which were in conformity with China Pharmacopoeia.