红花注射液生物活性测定方法的建立与质量评价

Bioactivity detection method development and quality evaluation of safflower injection

目的:建立基于生物活性测定的红花注射液质量评价方法,探究红花注射液不良反应的物质基础。方法:建立挑丝法测定不同批次的红花注射液对凝血酶的抑制作用;采用紫外分光光度法测定不同批次红花注射液中总黄酮;采用相关分析考察抗凝血酶效价与总黄酮之间的相关性。结果:部分不良反应批次的红花注射液抗凝血酶活性比正常批次强;抗凝血酶活性与总黄酮含量有显著相关。结论:所建立的基于抗凝血酶活性的红花注射液质量评价方法重复性好,灵敏简便,可作为现行红花注射液质量控制标准的补充方法;红花注射液的不良反应与总黄酮含量有关,总黄酮含量过高为部分红花注射液引起不良反应的原因。

Objective： To establish a bioassay method to evaluate the quality of safflower injection and to explore the constituents related to adverse reaction of safflower injection. Method： With fibrinogen as enzyme substrate, safflower injection as enzyme inhibitor, thrombin as work enzyme, the abilities of different batches of safflower injection in inhibiting the thrombin were determined. The total flavonoids were determined by ultraviolet spectrophotometry. The correlation between antithrombase potency and total flavonoids were analyzed. Result： There were significant difference in the inhibit ability of different batches of safflower injection. Some abnormal samples showed stronger inhibit ability than normal samples. Correlation analysis indicated that there were strong correlation between inhibit ability of safflower injection and total flavonoids. Conclusion： The method established possesses the characteristics of good reproducibility, high sensitivity, simplicity and convenience, and can serve as a supplementary method to control the quality of safflower injection. The adverse reaction of safflower injection is related to total flavonoids content. High content of total flav0noids is a part of the reasons for adverse reaction of safflower injection.