贴敷类医疗器械产品中非法添加樟脑、薄荷脑、冰片的情况分析

目的 检测26家企业34批次的贴敷类医疗器械产品中的樟脑、薄荷脑、冰片，为制订产品标准或补充检验方法提供参考。方法 采用气相色谱法对贴敷类医疗器械产品中的樟脑、薄荷脑、冰片进行初筛，再采用气-质联用法（GC-MS）对结果进行确证。结果 34批样品中樟脑、薄荷脑、冰片，10批次全部检出，3批次全部未检出，21批次部分检出。34批样品中樟脑共26批次检出；薄荷脑共22批次检出；冰片共18批次检出。结果未表明明显地域差异。结论 贴敷类医疗器械产品中樟脑、薄荷脑、冰片的添加情况非常普遍，形势较为严峻，建议补充该类产品非法添加樟脑、薄荷脑、冰片的法定检验方法，为产品质量控制、分类界定和行政执法提供技术支持。

Situation Analysis of Camphor, Menthol and Synthetic Borneol Added Illegally in Drug-free Cataplamat of Medical Devices

Objective To provide reference for standard and supplementary testing methods through analysis of camphor, menthol and synthetic borneol illegally added in 34 batches of drug-free cataplamat of medical devices from 26 enterprises. Methods Camphor, menthol and synthetic borneol in cataplamat of medical devices were confirmed by gas chromatograph (GC-MS). Results Camphor,menthol and synthetic borneol were all detected in 10 batches of samples. None of the 3 compounds were detected in 3 samples. One or two compounds were detected in 21 samples. In all 34 samples, camphor were detected in 26 samples, menthol were detected in 22 samples, synthetic borneol were detected in 22 samples. The result showed no regional differences. Conclusion Camphor, menthol and synthetic borneol illegally added in drug-free cataplamat of medical devices were common. The inspection method should be established to provide technical support for quality control, classification and administrative law enforcement.