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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 investigate the in vitro stability of compound gestodendron tablets and levonorgestrel tablets prepared by solid dispersion technique. Methods: The accelerated stability test (0 ~ 3 months) was used as the evaluation basis, and the related substances, contents and dissolution rates were evaluated. The stability of the self-made compound tablets was compared with that of the corresponding ordinary tablets. Results: The homemade gestodene tablets and the compound levonorgestrel tablets were significantly better than the ordinary tablets in terms of related substances, contents and dissolution. Conclusion: Solid dispersion technique can be used to improve and enhance the stability of oral short-acting contraceptive in vitro.