维生素C阴道缓释片的研制

目的:制备维生素C阴道缓释片,并全面考察其质量。方法:以羟丙甲纤维素为缓释材料制备维生素C阴道缓释片,采用紫外分光光度法测定其释放度,高效液相色谱法测定其有关物质和含量,并对其稳定性和局部刺激性进行考察。结果:样品在0.5,1,2 h的释放量分别为标示量的45%~75%,75%~90%,90%以上。高效液相色谱法测定维生素C的平均回收率为99.8%,RSD为0.78%。在各种试验条件下样品的性质稳定。局部无刺激性。结论:该处方工艺合理,质量可控,所得产品质量稳定,局部使用安全性良好。

Preparation of vitamin C vaginal sustained-release tablets

Objective:To prepare vitamin C vaginal sustained-release tablets and to investigate their quality overall.Methods:Vitamin C vaginal sustained-release tablets were prepared with hypromellose used as sustained-release material,and the release rate was determined by ultraviolet-visible spectrophotometry.The related materials and the content were determined by HPLC.Results:The release degrees of prepared tablets were 45%~75%,75%~90%,and above 90%,respectively,during 0.5,1,2 h.The average recovery and RSD of HPLC were 99.8% and 0.78%.The prepared tablets showed good stability under various experimental conditions.Conclusion:The design of formula and preparation technique are reasonable,and the quality is stable.It is safe for local use.