Page 107 - 《中国药科大学学报》2026年第2期
P. 107
学报
Journal of China Pharmaceutical University 2026, 57(2): 233 − 239 233
艾考糊精腹膜透析液中的 α-双羰基类降解产物
邻苯二胺衍生化 HPLC-MS/MS 测定研究
范潇敏，张丽娜，郑 枫 *
（中国药科大学药学院, 南京 211198）
摘 要 艾考糊精腹膜透析液在热灭菌过程中可产生具有细胞毒性的微量的 α-双羰基类降解产物，必须对其进行检查控
制。研究建立了这些降解产物的邻苯二胺（OPD）衍生化 HPLC-MS/MS 检查法，可用于艾考糊精腹膜透析液中 α-双羰基类
降解产物的定性定量分析。定性结果表明艾考糊精腹膜透析液中主要有 3-脱氧葡萄糖醛酮（3-DG）、3-脱氧半乳糖（3-
DGal）、4-脱氧葡萄糖醛酮（4-DG）和 3,4-二脱氧葡萄糖醛酮-3-烯（3,4-DGE）4 种 α-双羰基类降解产物，以及糠醛与 5-羟
甲基糠醛两种单羰基类降解产物。对 3-DG、3-DGal、3,4-DGE 及其结构类似物葡萄糖醛酮进行了方法学验证，结果表明 3-
DG、3-DGal、葡萄糖醛酮在 5~150 ng/mL 范围内线性关系良好，3,4-DGE 在 1~150 ng/mL 范围内线性关系良好，加样回收率均
在 86.8%~100.0% 之间，葡萄糖醛酮、3-DG 和 3-DGal 的检测限均约为 2.4 ng/mL，3,4-DGE 约为 0.5 ng/mL。本研究建立的方
法能够准确测定艾考糊精腹膜透析液中的 α-双羰基类降解产物，为其质量控制提供重要依据。
关键词 艾考糊精腹膜透析液；α-双羰基类降解产物；邻苯二胺；衍生化；HPLC-MS/MS
中图分类号 R917 文献标志码 A 文章编号 1000−5048(2026)02−0233−07
doi：10.11665/j.issn.1000−5048.2025080602
引用本文 范潇敏，张丽娜，郑枫. 艾考糊精腹膜透析液中的 α-双羰基类降解产物邻苯二胺衍生化 HPLC-MS/MS 测定研究 [J]. 中国药科
大学学报，2026，57（2）：233-239.
Cite this article as: FAN Xiaomin, ZHANG Lina, ZHENG Feng. Determination study of α-dicarbonyl degradation products in icodextrin
peritoneal dialysis solution by o-phenylenediamine derivatization HPLC-MS/MS[J]. J China Pharm Univ, 2026, 57(2): 233-239.
Determination study of α-dicarbonyl degradation products in icodextrin peritoneal
dialysis solution by o-phenylenediamine derivatization HPLC-MS/MS
FAN Xiaomin, ZHANG Lina, ZHENG Feng *
School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China
Abstract Icodextrin peritoneal dialysis solution may produce cytotoxic α-dicarbonyl degradation products
during heat sterilization, which must be monitored and controlled. The study established an o-phenylenediamine
(OPD) derivatization HPLC-MS/MS method for the detection of these degradation products, enabling qualitative
and quantitative analysis of α-dicarbonyl degradation products in icodextrin peritoneal dialysis solution. The
results indicated that the main α-dicarbonyl degradation products in icodextrin peritoneal dialysis solution are 3-
deoxyglucosone (3-DG), 3-deoxygalactosone (3-DGal), 4-deoxyglucosone (4-DG), and 3,4-dideoxyglucosone-3-
ene (3,4-DGE), along with two monocarbonyl degradation products, furfural and 5-hydroxymethylfurfural. The
quantitative method for 3-DG, 3-DGal, 3,4-DGE and their structural analog, glucosone, was validated. 3-DG, 3-
DGal, and glucosone exhibited good linear relationships within the range of 5-150 ng/mL, while 3,4-DGE
showed good linearity in the range of 1-150 ng/mL. The spiked recovery rates for all compounds were between
86.8% and 100.0%. The detection limits for glucosone, 3-DG, and 3-DGal were approximately 2.4 ng/mL, and
approximately 0.5 ng/mL for 3,4-DGE. The method established in this study can accurately determine α-
dicarbonyl degradation products in icodextrin peritoneal dialysis solution, providing an important basis for the
quality control.
收稿日期 2025-08-06 * 通信作者 E-mail：cpu_analyst@126.com
