复方曲肽注射液活性测定方法的研究

Study on Method of the Activity Determination of Compound Troxerutin and Poreine Cerebroside Injection

目的:研究复方曲肽注射液活性测定方法。方法:通过体外血小板聚集试验确定其活性限值测定法。结果:通过对复方曲肽注射液不同体积以及不同批次血小板聚集试验显示此方法重复性差、限值制定较难,无法寻找一个统一的标准来衡量其抑制血小板聚集功能。结论:应用血小板聚集试验考察复方曲肽注射液活性测定方法欠妥,建议进一步探索更好的方法检验产品活性。

Objective： To establish a new method on determining the activity of Compound Troxerutin and Poreine Cerebroside injection. Method： The standard limit was determined by platelet aggregation test. Result： The tests showed that the reproducibility was not good in different batches or in different volume, and it was hard to make a standard limit of activity, it is impossible to find a unified standard to measure the inhibition of platelet aggregation function. Conclusion ： With the platclet aggregation test, determination of activity of Compound Troxerutin and Poreine and Cerebroside injection was not suitable.