摘要
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。
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^-l（ r = 0.9 999） . The average recovery of flur-biprofen 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.
出处
《中国药房》
CAS
CSCD
北大核心
2007年第19期1484-1486,共3页
China Pharmacy
关键词
氟比洛芬
醇质体凝胶
制备
质量控制
Flurbiprofen
Ethosomal gel
Preparation
Quality control
