硝呋太尔阴道片的制备和质量控制

Study on Preparation and Stability of Nifuratel Vaginal Tablets

目的：制备硝呋太尔阴道片，建立质量标准并考察其稳定性。方法：采用正交设计试验，筛选处方组成，制备硝呋太尔阴道片；建立融变时限、有关物质、含量测定等质量标准，考察其稳定性。结果：硝呋太尔阴道片为黄色片，质量稳定，硝呋太尔浓度在40～400μg/ml范围内线性关系良好，r=0.9996（n=7），平均回收率为99.59%，RSD=0.61%（n=6）。该阴道片对光极为敏感。结论：该制剂处方合理，质量控制方法可靠，稳定性良好。

Objective: To prepare Nifuratel vaginal tablets and establish its quality control method,observe the stability. Methods: The ratio of excipients were optimized by orthogonal design and the nifuratel vagina tablets were perpared. Qual i ty control s tandards on mel t ing t ime and the determinat ion of related substances were es tablished to investigate the stability of drugs. Results: The preparation were yellow tablets with stable quality. During the concentrations of 40-400μg/ml nifuratel showed good linear relationship with the peak area,r2=0.9996(n=6).The average recovery rate was 99.59%,RSD 0.6% (n=6).The products were very susceptible to sunlight.Conclusion: The preparation has a reasonable prescription,method of quality control.