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目的比较原子吸收分光光度法(简称仪器法)与滴定法测定生物制品中硫柳汞含量的精密性和准确性,为仪器法列入《中国药典》(2010版)提供依据。方法由不同实验室分别采用仪器法与滴定法测定不同硫柳汞含量的样品,并进行精密性和准确性比较。结果不同实验室在测定硫柳汞含量为65.8、25.0及1.5μg/ml的样品时,仪器法的变异系数均小于滴定法,回收率较滴定法更接近100%;在测定硫柳汞含量为100μg/ml的样品时,两种方法回收率均不理想,但仪器法优于滴定法。结论仪器法测定生物制品中硫柳汞含量的精密性和准确性均优于滴定法,但仍需进一步完善。
Objective To compare the precision and accuracy of the determination of thimerosal in biological products by atomic absorption spectrometry (referred to as instrumental method) and titration method, and provide the basis for the inclusion of “instrumentation” in the “Chinese Pharmacopoeia” (2010 edition). Methods Samples from different thimerosal levels were determined by instrumentation and titration in different laboratories, and the precision and accuracy were compared. Results In different laboratories, when the thimerosal content was 65.8, 25.0 and 1.5 μg / ml, the coefficient of variation of the instrument was less than that of the titration method and the recovery rate was closer to 100% than the titration method. When the thimerosal content was 100 μg / ml Samples, the recovery of the two methods are not ideal, but the instrument method is better than titration. Conclusion The accuracy and accuracy of the instrument for the determination of thimerosal in biological products are better than titration, but still need further improvement.