摘要
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、体外释放等质控方法 ,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 % ,1h时药物在体外几乎完全释放 ,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 。
OBJECTIVE:T o develop a multiple emulsion of 5-fluorouracil,which had directional and slow-releasing effect.METHODS:Two step method with Polysorbate-80 and Span-80 as the emulsifier to prepare 5-fluorouracil multiple emulsion.Applied quality control on hygienical test,physical shape,content,output rate and drug releasing in vitro,and also the stability of the preparation had been evaluated by centrifuging.RESULTS:The hygienical test was accord with the criterion,in testing of content,the average rate of recovery was 100.4%,RSD=1 27%(n=4),the rate of output was 84 4%.The drug was almost released completely within 1h in vitro,and was stable after centrifuging.CONCLUSIONS:The preparation of the multiple emulsion is easy in technological process,reliable in quality control,stable in property,and also satisfied for clinical demand.
出处
《中国药房》
CAS
CSCD
1999年第6期257-258,共2页
China Pharmacy
关键词
5-氟尿嘧啶
复合乳剂
质量控制
产率
稳定性
fluorouracil multiple emulsion
quality control
output rate
stability
drug releasing in vitro
