目的 建立辅料乳糖的HPLC-RID检测方法。方法 色谱柱为Boston Green Amino氨基键合硅胶柱（250 mm×4.6 mm，5 μm），流动相为乙腈-水（70：30），体积流量1.0 mL/min，柱温45℃；检测器为示差折光检测器，检测器温度40℃，进样量10 μL。结果 乳糖在0.2～5.0 mg/mL范围内线性关系良好（r≥0.999 8），检测限为0.06 mg/mL，平均回收率为99.6%，相对标准偏差为0.7%。结论 该方法专属性好、操作简便、快速准确，适用于辅料乳糖的含量测定。

Objective To establish a method for determination of accessories lactose by HPLC-RID.Methods Boston Green Amino-NH₂ column (250 mm×4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-water (70:30). The flow rate was 1.0 mL/min. The column temperature was 45 ℃, the detector temperature was 40 ℃ and the injection volume was 10 μL.Results Lactose showed good linearity in the range of 0.2—5.0 mg/mL (r≥0.999 8). The detection limit was 0.06 mg/mL. The average recovery was 99.6% and the relative standard deviation was 0.7%.Conlusion The method is specific, convenient, fast and accurate, which can be used for determination of accessories lactose.