摘要
目的:探讨应用固体分散技术制备复方孕二烯酮片和复方左炔诺孕酮片的体外稳定性。方法:以加速稳定性试验(0～3个月)为评价依据,有关物质、含量和溶出度为评价指标,将自制的复方片与相应的普通片作稳定性对比研究。结果:自制复方孕二烯酮片及复方左炔诺孕酮片在有关物质、含量和溶出度方面均明显优于普通片。结论:固体分散技术可用于改善和提高口服短效避孕药的体外稳定性。
Objective： To explore the stability of combined gestodene tablets and levonorgestrel tablets by solid dispersion technique. Methods： Based on the accelerated stability test （0-3 months）, involving the evaluation of related substances, content and dissolution, the stability was compared between tablets of two formulations prepared by solid dispersion technique and the corresponding ordinary tablets. Result： The self- made combined gestodene tablets and levonorgestrel tablets were significantly better than the ordinary tablets in related substances, content and dissolution. Conclution： Solid dispersion technique can be used to improve the stability in vitro of oral short-acting contraceptives.
出处
《生殖与避孕》
CAS
CSCD
2012年第8期540-545,共6页
Reproduction and Contraception
基金
上海市计划生育科学研究所青年科技创新基金项目
课题编号Q2011-8
