2026年 04期

摘要(Abstract)：

为了研究人工晶状体的浸提液中是否存在紫外吸收剂的降解产物，采用超高效液相色谱-飞行时间质谱(UPLC-Q-TOF/MS)、液相色谱(HPLC)法，从保留时间、一级质荷比、二级碎片3个维度确定人工晶状体中2-羟基-4-(甲基丙烯酰氧基)二苯甲酮(4-MHBP)的降解产物；对降解产物进行定量表征，建立定量表征方法；采用甲醇、纯水对人工晶状体进行浸提，检测甲醇、纯水浸提液中的4-MHBP降解产物。将人工晶状体置于受照介质生理盐水中进行光照实验，检测光照后的受照介质中的4-MHBP降解产物。结果表明：人工晶状体中添加的4-MHBP的降解产物为2，4-二羟基二苯甲酮(BP-1)。UPLC-Q-TOF/MS法的BP-1的质量浓度检测范围为0.05~0.50 mg/L，线性相关系数为0.999 5，平均加标回收率为105.1%，回收率相对标准偏差为0.70%~3.77%；HPLC法的BP-1的质量浓度检测范围为0.5~20.0 mg/L，线性相关系数为0.999 0，平均加标回收率为103.2%，回收率相对标准偏差为0.38%~1.16%。原材料中添加4-MHBP的人工晶状体浸提液及光照后的浸提液中均无4-MHBP检出，仅检出BP-1，证实4-MHBP在可沥滤物检测前已发生降解。

关键词(KeyWords)：可沥滤物; 二苯甲酮类紫外吸收剂; 飞行时间质谱; 降解

基金项目(Foundation):浙江省重点研发计划项目(2021C03035);浙江省药品监管系统科技计划资助项目(2024020)

作者(Author):姜晓路，徐畅，徐萍华，何苗苗，张莉，沈亚男

DOI: 10.13349/j.cnki.jdxbn.20260608.001

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