关于缩宫素注射液中升压物质检查法的探讨

Approach on test of vasopressor substance in oxytocin injection

目的:对缩宫素注射液中升压物质检查法中发现的问题进行探讨。方法:SD 雄性大鼠颈总动脉插管监测血压,股静脉插管依次给入不同浓度、不同体积的垂体后叶标准品及缩宫素注射液样品,测定给药后的血压升高值。结果:在相同浓度条件下,大鼠对给药体积大者(1 mL·kg^(-1)),血压升高值差别明显,容易判定。在相同给药体积(每鼠0.1 mL)条件下,低浓度组的灵敏度高,高低剂量血压升高值差别大,分离效果较好。结论:现行中国药典中升压物质检查方法标准品浓度、体积规定不够明确,给操作者带来理解上的差异及样品判定上的差异,因而该检查方法急需再次论证给出一个确切的指导原则。

Objective：To study the method on vasopressor substance test of oxytocin injection. Methods：Male sprague - dewley rats. Rats were anesthetized, and the left common carotid artery was cannulated to measure blood pressure. Rats were administered through femoral vein. Record the blood pressure changes by different concentration and volume of hypophysenhineerilappen （HHL）standard substance and oxytocin injection. Results：At the same concentration, the increment of blood pressure was more significant with more administration volume （ 1 mL · kg^-1 ）. In low concentration group, the blood pressure increment of different dosage was significantat the same volume （0.1 mL per rat）. Conclusions：The regulations on concentration and volume of standard substance are ambiguity in the method vasopressor substances test which was defined by ChP. Therefore this method should be argumented again, to provide a precisely guide principle.