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 Diamonsil^TM（钻石）C₁₈ 色谱柱（200 mm × 4.6 mm，5 μm），流动相为乙腈 - 水（65︰35），柱温 25 ℃，体积流量 1.0 mL/min，检测波长为 230 nm，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 Diamonsil ^TMC₁₈ 色谱柱（200 mm × 4.6 mm，5 μm），流动相为甲醇 - 水（10︰90），柱温 25 ℃，体积流量 1.0 mL/min，检测波长为 244 nm，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 1.0～20.0 μg/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 6.0～60.0 μg/mL线性关系良好（r = 0.999 9, 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 Diamonsil^TM 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.

国家973科技计划（2006CB933303）