酶反应法定量测定血液制品中的枸橼酸离子  

Quantitative analysis of citrateions in blood products by enzyme reaction method

作　　者：赵璇 邵天舒 段艳 白亦昊 ZHAO Xuan;SHAO Tianshu;DUAN Yan;BAI Yihao(NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing Institute for Drug Control,Beijing,102206 P.R.China)

机构地区：[1]北京市药品检验研究院,国家药品监督管理局创新药物安全研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《华西药学杂志》2025年第2期185-188,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用酶反应法定量测定血液制品中枸橼酸离子的含量,并与2020年版《中国药典》枸橼酸离子测定的IEC-HPLC方法比较。方法采用酶反应法在365 nm检测并进行方法验证。选择人凝血因子Ⅷ和人凝血酶原复合物共22个批次,按2020年版《中国药典》中枸橼酸离子测定第二法平行分析,比较两者一致性。结果酶反应法于5~400 nmol线性关系良好(r=0.9999),检测限为1.14 nmol,在人凝血因子Ⅷ中的平均回收率为100.28%,RSD=1.10%(n=9),人凝血酶原复合物中平均回收率为100.33%,RSD=1.00%(n=9)。IEC-HPLC法在2~200 nmol线性关系良好(r=0.9999),检测限为0.31 nmol。酶反应法与IEC-HPLC法平行检测22个批次制品中枸橼酸离子的含量,无显著性差异。结论酶反应法环保、简便、重复性好、回收率高,结果可靠,可作为枸橼酸离子测定的补充方法。OBJECTIVE To establish an enzyme reaction method of sodium citrate in blood products,and to compare the developed method and IEC-HPLC method published in ChP 2020.METHODS The analytes were detected through enzyme reaction at a wavelength of 365 nm,and the analytical methods were subsequently validated.A total of 22 batches of human coagulation factorⅧand human prothrombin complex were selected and analyzed in parallel using the citrate ion determination method outlined in the 2020 edition of the Chinese Pharmacopoeia to assess the comparability of the two methods.RESULTS A good linearity relationship was obtained for the enzyme reaction method from 5 nmol to 400 nmol(r=0.9999),with a detection limit of 1.14 nmol.The average recoveries were 100.28%with RSD of 1.10%(n=9)in human coagulation factorⅧand 100.33%and RSD of 1.00%(n=9)in human prothrombin complex.A good linearity relationship was obtained for the IEC-HPLC method from 2 nmol to 200 nmol(r=0.9999),with a detection limit of 0.31 nmol.Statistical data showed that the amount of sodium citrate in 22 batches of blood products determined by enzyme reaction method and IEC-HPLC method showed no significant difference.These results demonstrated that enzyme reaction method and IEC-HPLC method were highly consistent in sodium citrate quantitative determination.CONCLUSION The enzyme reaction method is characterized by its environmental friendliness,simplicity,reproducibility,high recovery rates and reliability of results,demonstrateing potential utility as a supplementary technique for sodium citrate determination.

关 键 词：枸橼酸离子 血液制品 离子交换高效液相色谱法 酶反应法 含量测定 质量控制 方法比较 药典方法 

分 类 号：R917[医药卫生—药物分析学]