氟比洛芬醇质体凝胶的制备及质量控制

目的:制备氟比洛芬醇质体凝胶并建立其质量控制方法。方法:以乙醇注入法制备醇质体,研和法制备醇质体凝胶;采用紫外分光光度法测定其中主药含量;分别采用离心法和透析袋法测定醇质体的包封率和渗漏率。结果:所得凝胶涂展性好;氟比洛芬检测浓度线性范围为2.49～24.90μg.mL-1(r=0.9999);平均回收率为98.31%(RSD=2.13%,n=6);醇质体的包封率为91.73%,4、8h的渗漏率分别为3.51%、4.79%。结论:本制剂组方合理,制备工艺简便可行,质量稳定可控。

Preparation and Quality Control of Flurbiprofen Ethosomal Gel

OBJECTIVE:To prepare flurbiprofen ethosomal gel and to establish a method for its quality control.METHODS:The ethosome was prepared by ethanol injection method and the ethosomal gel was prepared using mixing method.The content of flurbiprofen was determined by UV spectrophotometry.The entrapment efficiency and the leak-in rate of flurbiprofen ethosome were determined by centrifugation and dialytic method,respectively.RESULTS:The gel obtained was good in spreading.The linear range of flurbiprofen was 2.49～24.90μg·mL-1(r=0.9 999).The average recovery of flurbiprofen was 98.31%(RSD=2.13,n=6).The entrapment efficiency of the ethosome was 91.73%.The leak-in rate at 4h and 8 h was 3.51% and 4.79%,respectively.CONCLUSION:This preparation is reasonable in formula,its preparative technique is simple and convenient in operation,and its quality is stable and controllable.