论文部分内容阅读
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 explore the problems found in the method of examining the substances of increasing pressure in oxytocin injection. Methods: Male SD rats were intubated with carotid artery for monitoring blood pressure and femoral vein catheterization. Samples of different concentrations and different volumes of posterior pituitary gland and oxytocin injection were administered to determine the blood pressure after administration. Results: Under the same concentration, the rats with large volume of administration (1 mL · kg ~ (-1)) had obvious difference in blood pressure, which was easy to judge. Under the same administration volume (0.1 mL per rat), the sensitivity of the low-concentration group was high, the differences of the elevated blood pressure of the high-low dose group were large, and the separation effect was better. Conclusion: The current Chinese Pharmacopoeia in the step-up test method standard concentration, volume is not clear enough to bring the understanding of the operator differences and differences in sample determination, so the examination method urgently needed to re-demonstrate a precise guideline .