前列地尔脂微球注射液中游离药物浓度测定方法研究  

Determination Method of Free Drug Concentration in Lipid Microspheres Incorporating Prostaglandin E_1

作　　者：马玉樊[1] 卢婷利[1] 崔晗[2] 周四元[2] 陈涛[1,2] 

机构地区：[1]西北工业大学生命学院,陕西西安710072 [2]中国人民解放军第四军医大学,陕西西安710032

出　　处：《中国药业》2014年第14期46-48,共3页China Pharmaceuticals

摘　　要：目的建立检测前列地尔脂微球中游离药物浓度的方法。方法采用不同规格的超滤膜、以不同离心速率对前列地尔脂微球注射液样品进行处理，高效液相色谱-质谱法检测水相中游离药物浓度。结果用10K超滤膜滤过、以5000r／min速率4℃离心30min，对前列地尔脂微球注射液样品进行处理；采用高效液相色谱-质谱法检测水相中游离药物浓度，结果样品在5h内稳定，RSD为0．43％，方法重现性良好。前列地尔质量浓度在5～60ng／mL范围内与峰面积线性关系良好，线性回归方程为Y=5．7586X＋7．1275，r=0．9972（n=7），最低检测限5ng／mL。方法的平均回收率为96．4％，RSD为0．88％。结论该法可快速简便有效地检测出前列地尔脂微球注射液中游离前列地尔的浓度，重现性良好。Objective To develop a method for determining the free drug concentration in Lipid Microspheres Incorporating Prostaglandin El. Methods The samples of Lipid Microspheres Incorporating Prostaglandin E1 were processed with different specifications of uhrafiltration membrane and different centrifugation speeds,then the free drug concentration in the water phase was detected by the high performance liquid chromatography-mass spectrometry（HPLC-MS）. Results The samples were processed by the 10 K ultrafihration membrane and eentrifugating for 30 min with 4 ℃ 5 000 r/min,then the free drug concentration was detected by HPLC-MS. The test samples were stable within 5 h, RSD=0. 43%.The sample reproducibility was good. The mass concentration of prostaglandin E1（PGE1） in the range of 5-60 ng/mL showed the good linear relation. The linear equation was Y= 5. 758 6X ＋ 7. 127 5, r = 0.997 2（ n = 7）. The lowest detection limit was 5 ng/mL. The average recovery rate was 96.4% with RSD =0. 88%. Conclusion This method can detect the free PGE1 concentration in Lipid Microspheres Incorporating Prostaglandin E1 rapidly,simply and effectively with good reproducibility.

关 键 词：前列地尔 前列地尔脂微球注射液 高效液相色谱一质谱法 游离前列地尔浓度 

分 类 号：R927.2[医药卫生—药学] R971