目的：为准确分析重组人粒细胞巨噬细胞集落刺激因子（ｒＨｕＧＭＣＳＦ）半成品及其制剂的纯度和表达的正确性。方法：用毛细管区带电泳测定了２批ｒＨｕＧＭＣＳＦ半成品和３批ｒＨｕＧＭＣＳＦ注射液的纯度。用基体辅助激光解吸飞行时间质谱和电喷雾质谱测定了２批ｒＨｕＧＭＣＳＦ半成品的分子量。用毛细管等电聚集法测定了ｒＨｕＧＭＣＳＦ半成品的等电点。结果：２批半成品中１批含有少量二聚体，且含有４个不同等电点的组分，另１批表达不正确；２批成品均存在大量杂质。结论：发现有些ｒＨｕＧＭＣＳＦ样品有生物学活性，但表达不正确，纯度也不高；各分析方法是互补的，不能相互替代。 Objective: To accurately analyze the purity and expression of recombinant human granulocyte-macrophage colony-stimulating factor (rHuGM-CSF) semi-finished products and their preparations. Methods: The purity of two batches of rHuGMCSF semifinished products and three batches of rHuGMCSF injection were determined by capillary zone electrophoresis. The matrix-assisted laser desorption time of flight mass spectrometry and electrospray mass spectrometry were used to determine the molecular weights of two batches of rHuGM-CSF semi-finished products. The isoelectric point of rHuGMCSF semi-finished products was determined by capillary isoelectric focusing method. Results: One batch of two batches of semi-finished products contained a small amount of dimer and contained four components with different isoelectric points, and the other batches were incorrectly expressed. A large number of impurities were found in the two batches of finished products. Conclusion: Some samples of rHuGMCSF were found to be biologically active, but their expression was incorrect and their purity was not high. The analytical methods were complementary and could not substitute each other.