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作 者:杨硕晔[1] 王杏林[2] 杨志强[2] 司端运[2]
机构地区:[1]河南大学药学院,河南开封475001 [2]天津药物研究院,天津300193
出 处:《药物评价研究》2009年第1期38-42,共5页Drug Evaluation Research
基 金:国家973科技计划(2006CB933303)
摘 要:目的:建立RP-HPLC法测定洛莫司汀-碘海醇复方脂质体中药物的含量及包封率。方法:使用DiamonsilTM(钻石)C18色谱柱(200mm×4.6mm,5μm),流动相为乙腈-水(65︰35),柱温25℃,体积流量1.0mL/min,检测波长为230nm,鱼精蛋白凝聚法分离游离药物,测定复方脂质体中洛莫司汀的含量及包封率;使用DiamonsilTMC18色谱柱(200mm×4.6mm,5μm),流动相为甲醇-水(10︰90),柱温25℃,体积流量1.0mL/min,检测波长为244nm,鱼精蛋白凝聚法分离游离药物,测定复方脂质体中碘海醇的含量及包封率。结果:洛莫司汀与辅料及溶剂峰分离良好,在1.0~20.0μg/mL线性关系良好(r=1.0,n=5),回收率为99.0%~101.0%;碘海醇与辅料及溶剂峰分离良好,在6.0~60.0μg/mL线性关系良好(r=0.9999,n=5),回收率为99.0%~101.0%。结论:该方法准确、简单,可用于洛莫司汀-碘海醇复方脂质体含量及包封率的测定。Objective: To establish an HPLC method for determining the content and entrapment efficiency of lomustine-iohexol compound liposomes. Methods: The separation was performed with a Diamonsil TM C18 column(200 mm × 4.6 mm, 5 μm), the mobile phase was acetonitrile-water(65∶35), the drug was detected at 230 nm wavelength and the flow rate was 1.0 mL/min, with column temperature of 25℃, protamine aggregation method was applied to separating the free drug and liposomes, for determining the content and entrapment efficiency of lomustine;the separation was performed with a DiamonsilTM C18 column(200 mm × 4.6 mm, 5 μm), the mobile phase was methanol-water(10∶90), the drug was detected at 244 nm wavelength and the flow rate was 1.0 mL/min, with column temperature of 25 ℃, protamine aggregation method was applied to separating the free drug and liposomes, for determining the content and entrapment efficiency of iohexol. Results: Lomustine and iohexol can be well separated with a good linear relationship in the rages of 1.0 — 20.0 μg/mL(r = 1.0, n = 5)and 6.0 — 60.0 μg/mL(r = 0.999 9, n =5), their average recoveries were both between 99.0 % — 101.0 %, respectively. Conclusion: This method is accurate and simple, and can be well used to determine the contentand entrapment efficiency of lomustine-iohexol compound liposomes.
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