生物来源的缩宫素注射液升压物质检查替代方法的研究

Study on alternative method for vasopressin impurity test of oxytocin injection from biological extraction

目的 对生物来源缩宫素注射液的升压物质检查进行大鼠血压法和HPLC法的替代研究。方法 建立体外升压物质检查的HPLC法并进行方法验证,分别使用HPLC法和大鼠血压法对生物来源的缩宫素注射液样品和模拟样品进行升压物质检查。结果 在该文HPLC色谱条件下,升压素与相邻杂质峰之间的分离度均符合要求,在210~13 330 IU·L^(-1)范围内,升压素浓度与其色谱峰面积呈良好线性关系,r=0.999 9。HPLC法与现行标准中的生物检查法-大鼠血压法检测结果一致。结论 该法专属性好、灵敏、准确,可作为升压物质检查法代替现行标准中的大鼠血压法。

Aim To explore the alternative study on rat blood pressure method and HPLC method for vasopressin impurity test of oxytocin injection from biological extraction. Methods The HPLC method for the vasopressin impurity test in vitro was established and validated. The bio-extraction oxytocin injection samples and simulated samples were examined for vasopressin impurity by HPLC and rat blood pressure methods respectively. Results Vasopressin and adjacent impurity peaks were successfully separated by the established method. In the range of 210~ 13 330 IU·L^(-1) the concentration of vasopressin had a good linear relationship with its peak area with r= 0.999 9. The results of HPLC method were consistent with the biological examination method-rat blood pressure method in the current standard. Conclusions The method is proved to be specific,sensitive,and accurate,which can be used as a test method for vasopressin impurity to replace the rat blood pressure method in the current standard.