目的：建立 RP-HPLC 法測(cè)定洛莫司汀-碘海醇復(fù)方脂質(zhì)體中藥物的含量及包封率。方法：使用 Diamonsil^TM（鉆石）C₁₈ 色譜柱（200 mm × 4.6 mm，5 μm），流動(dòng)相為乙腈 - 水（65︰35），柱溫 25 ℃，體積流量 1.0 mL/min，檢測(cè)波長(zhǎng)為 230 nm，魚精蛋白凝聚法分離游離藥物，測(cè)定復(fù)方脂質(zhì)體中洛莫司汀的含量及包封率；使用 Diamonsil ^TMC₁₈ 色譜柱（200 mm × 4.6 mm，5 μm），流動(dòng)相為甲醇 - 水（10︰90），柱溫 25 ℃，體積流量 1.0 mL/min，檢測(cè)波長(zhǎng)為 244 nm，魚精蛋白凝聚法分離游離藥物，測(cè)定復(fù)方脂質(zhì)體中碘海醇的含量及包封率。結(jié)果：洛莫司汀與輔料及溶劑峰分離良好，在 1.0～20.0 μg/mL線性關(guān)系良好（r = 1.0, n = 5），回收率為 99.0 %～101.0 %；碘海醇與輔料及溶劑峰分離良好，在 6.0～60.0 μg/mL線性關(guān)系良好（r = 0.999 9, n = 5），回收率為99.0 %～101.0 %。結(jié)論：該方法準(zhǔn)確、簡(jiǎn)單，可用于洛莫司汀-碘海醇復(fù)方脂質(zhì)體含量及包封率的測(cè)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.

國(guó)家973科技計(jì)劃（2006CB933303）