铁离子对盐酸普鲁卡因注射液含量测定的影响

目的研究铁离子对盐酸普鲁卡因注射液含量测定的影响。方法在制备盐酸普鲁卡因注射液时,分别加入不同量铁离子和乙二胺四醋酸二钠(EDTA-2Na),然后对其成品用永停滴定法分别测定其含量,记录滴定到达终点时间,计算盐酸普鲁卡因回收率并进行比较。结果铁离子浓度在一定范围内和所加铁离子被EDTA-2Na络合的样品对含量测定无影响,铁离子浓度超过一定范围的样品对含量测定有显著影响。结论铁离子浓度超过一定范围的样品对含量测定有显著影响,在盐酸普鲁卡因注射液生产过程中应严格控制各个环节,限制制备过程中铁离子的污染。

Effect of Iron ion on the assay of procaine hydrochloride injection

OBJECTIVE To study the effect of iron ion on the determination of procaine hydroehloride injection. METHODS When procaine hydrochloride injection was prepared, various amount iron ion and EDTA- 2Na were added, and dead--stop titration was used for the determination of procaine hydroehloride in the injection, record the stop time and calculate the content respectively, compare the mean recovery. RESULTS When iron ion concentration was in a specific range or iron ion complexed with EDTA- 2Na, no significant effect on the assay was found; when iron ion over a specific range, effect on the assay was very clear. CONCLUSION If iron ion over a specific range, it will significantly affects the concentration determination of procaine hydrochloride injection,in order to avoid pollution, it should be controlled strictly in the process of preparation.