目的 建立高效液相色谱-蒸发光散射检测（high performance liquid chromatography with evaporative light scattering detector，HPLC-ELSD）法测定猪纤维蛋白原粉中海藻糖含量，并对方法进行验证和初步应用。方法 以乙腈/水(含0.1%NH₄OH)(70/30 体积分数)为流动相、进样量10 μl、流速1.0 ml/min、柱温25 ℃、氮气流速2.0 L/min、漂移管温度85 ℃、Xbridge-NH₂色谱柱对样品进行分离，采用蒸发光散射检测器测定海藻糖含量。验证该方法专属性、线性、准确度、精密度和耐用性，并应用该方法对3批猪纤维蛋白原粉样品中海藻糖含量进行检测。结果 该方法的空白对照、空白溶剂和空白溶液无干扰峰出现；海藻糖浓度在0.1 006~0.5 030 mg/ml时与峰面积线性关系良好；其中低、中、高3个浓度水平的总平均回收率为100.20%，相对标准偏差（relative standard deviation，RSD）＜5.0%；2名实验员各重复6次测定海藻糖结果的RSD分别为1.14%、3.10%；流速、流动相比例、柱温和漂移管温度等检测方法参数分别微调后与原方法测得的含量之比在97.90%~102.67%范围内。3批猪纤维蛋白原粉样品中海藻糖含量分别为63.10%、64.33%、64.16%，均符合企业标准，适用于海藻糖含量测定。结论 成功建立了猪纤维蛋白原粉中海藻糖含量的HPLC-ELSD检测法，该方法的专属性、线性、准确度、精密度、耐用性均良好。

Objective To establish a method for determination of trehalose in porcine fibrinogen powder by high performance liquid chromatography with evaporative light scattering detector (HPLC-ELSD), and perform method validation and application. Methods The porcine fibrinogen powder samples were separated based on Xbridge-NH₂ columns using 70/30 acetonitrile/H₂O(with 0.1% NH₄OH) as moblie phase, sample volume 10 μl, flow rate 1.0 ml/min, column temperature 25 ℃, nitrogen flow rate 2.0 L/min, and drift tube temperature 85 ℃. The content of trehalose was determined by ELSD. The specificity, linearity, accuracy, precision, and durability of the method were validated. The method was applied to determination of trehalose in three batches of porcine fibrinogen powder. Results  No interference peak appeared in the blank control, blank solvent and solution, which showed strong specificity. The concentration of trehalose showed good linear relationship to the peak area in the range of 0.1006~0.5030 mg/ml. The overall average recovery at low, medium and high concentration levels was 100.20%, with a relative standard deviation(RSD)＜5.0%.The RSD of repeatability by two experimenters were 1.14% and 3.10%, respectively. After the change of flow rate, mobile phase ratio, column temperature and drift tube temperature, the durabilities were in the range of 97.90%-102.67%. The trehalose contents of three batches of porcine fibrinogen powder were 63.10%, 64.33% and 64.16%, complying with the enterprise standards. Conclusion HPLC-ELSD detection for trehalose in porcine fibrinogen powder is successfully established. This method has good specificity, linearity, accuracy, precision, and durability.