复方氟尿嘧啶注射液包封率的测定方法研究  

Study on Determination Method of Entrapment Efficiency of Compound Fluorouracil Injection

作　　者：张迪[1] 姜梅[2] 郭宏伟[1] 李沫[1] 李尚颖[1] 孙苓苓[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023 [2]沈阳市药品检验所,沈阳110001

出　　处：《中国药房》2013年第29期2758-2760,共3页China Pharmacy

摘　　要：目的:建立复方氟尿嘧啶注射液(多相脂质体)包封率测定方法。方法:采用超滤离心法分离药物,高效液相色谱法测定药物含量并计算包封率。色谱柱以十八烷基硅烷键合硅胶为填充剂,流动相为水(0.05mol/L磷酸溶液调节pH至3.5)-甲醇(95:5),检测波长为265nm。结果:超滤离心管对样品无吸附,氟尿嘧啶检测质量浓度线性范围为3.892～194.6μg/m(lr=0.9999,n=6),平均回收率为99.59%(RSD=1.3%,n=9),重复性试验RSD=0.8%(n=6)。结论:建立的包封率测定方法操作简单,结果准确、重复性好。OBJECTIVE：To develop a method for the determination of the entrapment efficiency of Compound fluorouracil injection（multiphasic liposomes）.METHODS：The samples were separated by ultrafiltration centrifugation.HPLC method was used to determine the contents of drugs and entrapment efficiency was calculated.The loading agent of chromatographic column was octadecylsilane chemically bonded silica,and mobile phase consisted of water（pH adjusted to 3.5 using 0.05 mol/L phosphoric acid）-methanol（95：5）.The detection wavelength was set at 265 nm.RESULTS：The samples had not absorbing effct to ultrafiltration centrifuge tube.The linear range of fluorouracil were 3.892-194.6 μg/ml（r=0.999 9,n=6）with average recovery of 99.59%（RSD=1.3%,n=9）.RSD of repeatability test was 0.8%（n=6）.CONCLUSIONS：The method for entrapment effeciency is simple,accurate and reproducible.

关 键 词：复方氟尿嘧啶注射液 包封率 超滤离心法 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学] R979.1