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建立凝血酶冻干粉分子量分布测定方法。色谱柱为蛋白专用柱TSK GEL G2000 SW(7.5mm×300mm,10μm),以p H6.86磷酸盐缓冲液为流动相,流速0.5m L/min,紫外检测器,波长280nm。凝血酶冻干粉重均分子量为80ku~95ku。所建立的凝血酶冻干粉分子量测定方法具有快速、简便和重复性好的特点,为提高和完善制剂的质量标准提供了依据,同时可作为特征图谱从蛋白分子量角度来控制该产品的内在质量。
To establish a method for determination of molecular weight distribution of thrombin lyophilized powder. The chromatographic column was TSK GEL G2000 SW (7.5 mm × 300 mm, 10 μm). The mobile phase consisted of p H6.86 phosphate buffer at a flow rate of 0.5 mL / min. The detector was UV at 280 nm. Thrombin lyophilized powder weight average molecular weight of 80ku ~ 95ku. The established thrombin freeze-dried powder molecular weight determination method has the characteristics of fast, simple and good repeatability, which provides a basis for improving and perfecting the quality standard of the preparation, and can also be used as the characteristic spectrum to control the intrinsic quality of the product from the molecular weight of the protein .