目的 建立鹿瓜多肽注射液、注射用鹿瓜多肽中半乳糖、葡萄糖、甘露糖、蔗糖和果糖的离子色谱测定方法。方法 使用Dionex CarboPac PA20色谱柱（150 mm×3 mm，6 μm）；Dionex PA20 Guard预柱（30 mm×3 mm，6 μm）；流动相：水-250 mmol/L氢氧化钠溶液-1 mol/L醋酸钠溶液，梯度洗脱；体积流量：0.4 mL/min；柱温：30 ℃；进样量：25 μL；检测器：电化学检测器。结果 半乳糖、葡萄糖、甘露糖、蔗糖、果糖的线性范围均为0.1～10.0μg/mL（r＞0.995 0），平均回收率分别为96.52%、97.80%、97.03%、97.72%、98.35%，RSD值分别为2.88%、1.49%、2.01%、1.83%、1.84%。结论 该方法快速准确、重现性好，可用于鹿瓜多肽注射剂中糖类杂质的测定。

Objective To establish a ion chromatography method for determination of galactose, glucose, mannose, sucrose, and fructose in Cervus and Cucumis Polypeptide Injection and Cervus and Cucumis Polypeptide for injection. Methods Dionex CarboPac PA20 column (150 mm × 3 mm, 6 μm) and Dionex PA20 Guard column (30 mm × 3 mm, 6 μm) was used. Mobile phase was water-250 mmol/L sodium hydroxide solution-1 mol/L sodium acetate solution with gradient elution. Volume flow rate was 0.4 mL/min, column temperature was set at 30 ℃, and injection volume was 25 μL. Electrochemical detector was adopted. Results The linear ranges of galactose, glucose, mannose, sucrose, and fructose were 0.1—10.0 μg/mL (r > 0.995 0), and their average recoveries were 96.52%, 97.80%, 97.03%, 97.72%, and 98.35% with RSD 2.88%, 1.49%, 2.01%, 1.83%, and 1.84%. Conclusion The method is fast, accurate, and has good reproducibility, and can be used for the determination of carbohydrate impurities in Cervus and Cucumis Polypeptide Injection.

R927.1

天津市市场监督管理委员会科技计划项目（2020-W26）；天津市药品监督管理局科技计划项目（2020-YJ02）