去甲万古霉素标准品量值传递方法的研究

Study of A potency value transmission method for norvancomycin reference standard

目的:建立去甲万古霉素标准品量值传递的方法。方法:选用稳定物质阿莫西林和水杨酸为参比基准物;通过 HPLC测定参比基准物与去甲万古霉素的标准曲线,以其斜率的比值表征二者的摩尔紫外吸收系数比值,并作为校正因子;通过参比基准物的量值结合校正因子来传递去甲万占霉素的量值。结果:阿莫西林与去甲万古霉素的校正因子为1.003 7,RSD1.0%(n=6),水杨酸与去甲万古霉素的校正因子为1.003 2,RSD1.2%(n=6)。结论:通过校正因子可将去甲万古霉素标准品的量值准确的传递下去。

Objective： To establish a potency value transmission method for national reference standard of norvancomycin. Method： Amoxicillin and salicylic acid was selected as intermediate reference substance . Calibration curves of both the intermediate reference substance and norvancomycin were determined by HPLC and the slope ratio of these two curves was defined as a calibration factor , which could represent the ratio of the two mole ultraviolet absorption coefficients. Thus, the potency value of norvancomycin reference standard could be transmitted by the value of the intermediate reference substance combining the calibration factor . Results：The calibration factor of amoxicillin is 1. 003 7 with RSD 1.0% （ n = 6） and the calibration factor of salicylic acid is 1. 003 2 with RSD 1.2% （n = 6）. Conclusion：The potency value of norvancomycin reference standard could be transmitted accurately to keep constant continously.