5-氟尿嘧啶复乳的研制

Preparation of 5-fIuorouracil multiple emulsion

目的;研究具有缓释和定向作用的5-氟尿嘧啶复合乳剂.方法:以吐温-80和司盘-80为乳化剂,用两步法制备5-氟尿嘧啶复合乳剂,建立了卫生学、形态观察、含量测定、产率测定等质控方法,并用离心法进行稳定性考察.结果:卫生学检查符合规定,含量测定平均回收率100.4%,RSD=1.27%(n=4),产率为84.4%,并且复乳稳定无变化.结论:制备该复乳工艺简单.质控可靠,性质稳定,可满足临床用药需求.

AIM: To develop a multiple emulsion of 5-fluorouracil ,which had directional and slow-releasing effect. METHODS: Using Polysorbate-80 and Span-80 as the emulsifier, the 5-fluorouracil multiple emulsion was prepared by 2 steps. The method of quality control on hygienical test ,physical shape,content and output rate. The stability had also been evalu-ated by centrifuging. RESULTS: In the test of content, the average rate of recovery was 100. 4% and RSD=1. 27%(n = 4). The output rate was 84. 4% and the emulsion was stable after centrifuging. CONCLUSION. The multiple emulsion can be developed easily. The quali-ty is also to be controlled and stably kept. This preparation is an useful medicine for the clin-ic.