缩宫素注射剂生物测定法与HPLC含量测定比较

Bioassa Compared with HPLC for Oxytocin Injections

通过比较缩宫素注射剂生物测定法和高效液相色谱法含量测定结果,探讨缩宫素注射剂高效液相色谱法含量测定替代生物测定效价的合理性和准确性。对10批缩宫素注射剂进行生物测定法和高效液相色谱法含量测定。结果显示,10批缩宫素注射剂的生物测定法和高效液相色谱法含量测定结果无明显差异,初步表明通过高效液相色谱法测定含量可以代替注射用缩宫素的生物测定法结果。

To compare the results of bioassay and content determination of HPLC for oxytocin injection,the rationality and accuracy of content determination by HPLC instead bioassay of oxytocin injection were explored.The content determination of 10 batches of oxytocin injection was determined by bioassay HPLC.There was no significant difference between the bioassay of 10 batches of oxytocin injection and the content determination of HPLC,and it was preliminarily shown that the content determination by HPLC could replace the bioassay results of oxytocin injection.