研究关于快速检测技术的研究,非法化学化合物添加到外部复合剂
Xiaoan Li1, Yaning Cui2, Li Liu1
1Ankang Inspection and Testing Center for Food and Drug, Ankang, China.
Biomedical chromatography : BMC
|March 11, 2025
概括
许多局部止痛装置含有非法制药药物,造成健康风险. 一种新的HPLC-MS/MS方法在大多数测试的医疗器械中检测到这些危险的添加剂,包括尼梅苏利德和阿司匹林.
科学领域:
- 制药分析 制药分析
- 医疗器械安全 医疗器械安全
- 公共卫生 公共卫生
背景情况:
- 局部止痛产品,如复合剂和医疗器械,可能含有未申报的药品.
- 消费者往往不知道这些非法添加剂及其相关的健康风险.
- 医疗器械的现有测试方法在检测某些化学成分方面存在局限性.
研究的目的:
- 改进和优化样品处理和提取方法,以检测医疗器械中的非法化学添加剂.
- 通过使用改进的分析方法来确定安装医疗器械中非法添加的化学品的含量.
- 评估当前止痛医疗器械中制药药物伪造的普遍性.
主要方法:
- 开发和应用一个优化的样品制备和提取技术.
- 使用高性能液体染色学与并联质谱法 (HPLC-MS/MS) 进行化学分析.
- 分析了47批附着医疗器械,以检测非法化学添加剂的存在.
主要成果:
- 在47个分析的医疗器械批发中,在37个批发中检测到非法化学药物.
- 在大多数阳性样本中发现了非类固醇抗炎药物,特别是尼梅苏利德和阿司匹林.
- 这些发现表明,医疗器械被未申报的制药化合物广泛改.
结论:
- 这项研究证实,当前止痛医疗器械中存在非法添加的药物药物.
- 优化分析方法对于准确检测伪造剂至关重要.
- 消费者面临着严重的风险,原因是由于多种有毒化合物的联合暴露,来自造产品.
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