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目的:建立降纤酶注射剂的色谱分析方法,为提高该品种的国家标准提供实验依据。方法:采用纤维蛋白原凝固法、反相高效液相色谱法和高效分子排阻色谱法对国内12个生产企业的注射用降纤酶进行检测分析。结果:各企业样品的反相高效液相色谱图差别较大,高效分子排阻色谱法未检出聚合物,酶活力与反相高效液相色谱图中的主峰面积有相关性,与高效分子排阻色谱图中的主峰呈一定趋势分布。结论:反相高效液相色谱法和高效分子排阻色谱法可以用于降纤酶注射剂的检测分析,色谱图中的主峰面积与其酶活力存在一定的相关性。
Objective: To establish a chromatographic analysis method for defibrase injection and provide experimental basis for improving the national standard of this variety. Methods: Fibrinogen coagulation, RP-HPLC and high-performance size exclusion chromatography were used to detect and analyze the defibrase for injection in 12 domestic manufacturing enterprises. Results: The results of RP-HPLC showed that there was a great difference between the samples of different companies. High-performance molecular weight exclusion chromatography (LC-MS) did not detect the polymer. The correlation between enzyme activity and main peak area in reversed-phase high performance liquid chromatography The main peak in the exclusion chromatogram showed a trend distribution. CONCLUSION: RP-HPLC and HPLC-MS can be used for the detection and analysis of defibrase injection. There is a certain correlation between the main peak area in the chromatogram and its enzyme activity.