维生素C阴道缓释片的研制  

Preparation of vitamin C vaginal sustained-release tablets

作　　者：黎银波[1] 李健和[1] 彭六保[1] 

机构地区：[1]中南大学湘雅二医院,药学院长沙410011

出　　处：《中国新药杂志》2007年第19期1605-1609,共5页Chinese Journal of New Drugs

摘　　要：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。Objective：To prepare vitamin C vaginal sustained-release tablets and to investigatetheir 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 spectroophotometry. 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.

关 键 词：维生素C 阴道缓释片 质量控制 稳定性 局部刺激性 

分 类 号：R943.41[医药卫生—药剂学] R977.23[医药卫生—药学]