| 沈永,刘雪婷,刘爱娟,孟强,万敏.贴敷类医疗器械中薄荷脑等中药成分的分析及评价[J].中国药事,2023,(12):1445-1450 |
| 贴敷类医疗器械中薄荷脑等中药成分的分析及评价 |
| Analysis and Evaluation of Menthol and other Traditional Chinese MedicineIngredients in Applied Medical Devices |
| 投稿时间：2023-01-16 |
| DOI：doi:10.16153/j.1002-7777.2023.12.015 |
| 中文关键词: 医用退热贴 薄荷脑 挥发油测定法 气相色谱-质谱联用法 中药成分 |
| 英文关键词: medical antipyretic patch menthol determination of volatile oil GC-MS traditional Chinesemedicine ingredients |
| 基金项目:医疗器械中非法添加药物的识别及含量测定方法研究（编号 SDNMPAFZLX202203） |
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| 中文摘要: |
| 目的：利用气相色谱-质谱联用法对医用退热贴、退热凝胶、冷敷贴中的薄荷脑及其他中药成分进行定性识别及含量测定。方法：建立气相色谱-质谱联用的方法，采用HP-INNOWAX（30 m×0.25mm，0.25 μm）色谱柱，柱温为程序升温（80 ℃保持2 min，以20 ℃·min-1的速率升温至240 ℃，保持5 min），进样口温度250 ℃，分流比5∶1，采集类型Scan，扫描范围（m/z）50~500。样品浸提方式参考《中华人民共和国药典》（2020年版）四部中的挥发油测定法甲法，检测样品中薄荷脑、樟脑、冰片的含量。结果：薄荷脑质量浓度在0.2 ~20 mg·L-1范围内线性良好（r=0.9997），平均加标回收率（n=6）为90.6%~101.2%。利用该方法对收集到的3种共24批医用退热贴敷类产品进行检测，9批医用退热贴中有5批检出薄荷脑，其含量为0.14~1.07 mg·片-1；6批医用退热凝胶均检出薄荷脑，其含量为0.05~3.80 mg·g-1；9批医用冷敷贴中有5批检出薄荷脑，含量为0.79~78.58 mg·片-1。此外，24批医用退热贴敷类产品中9批检出含有樟脑、冰片，樟脑的最大添加量为73.32 mg·片-1，冰片的最大添加量为123.72 mg·片-1。结论：市场上的医用退热贴敷类医疗器械中有一定程度的禁止添加成分如薄荷脑、樟脑及冰片的检出，需要加强关注。 |
| 英文摘要: |
| Objective: To identify and determine the content of menthol and other traditional Chinese medicineingredients in medical antipyretic patches, antipyretic gel and medical cold compress patches by GC-MS.Methods: The method of gas chromatography-mass spectrometry was established, using HP-INNOWAX(30 m×0.25 mm, 0.25 μm) as chromatographic column, column temperature was programmed temperature rise(80 ℃ for 2 min, 20 ℃·min-1 temperature rise rate to 240 ℃ for 5 min), the inlet temperature was 200 ℃ withthe split ratio was 5∶1, the scan range was 50-500 (m/z) in scan mode. Sample extraction method refered to the determination of volatile oil in the Pharmacopoeia of the People's Republic of China (Part Ⅳ, 2020 edition)to detect the content of menthol, camphor and borneol in the sample. Results: Menthol showed good linearrelationship within 0.2-20 mg·L-1 (r=0.9997), the average recoveries (n=6) were 90.6%-101.2%. The method wasused to detect 24 batches of 3 kinds of medical antipyretic paste products collected. Among them, Menthol wasdetected in 5 batches out of 9 batches of medical antipyretic patches, with a content of 0.14-1.07 mg·piece-1.Menthol was detected in all of 6 batches of medical antipyretic gels, with a content of 0.05-3.80 mg·g-1.Menthol was detected in 5 batches out of 9 batches of medical cold compress patches, with a content of 0.79-78.58 mg·piece-1. In addition, 9 batches out of 24 batches of medical antipyretic paste products were found tocontain camphor and borneol, the maximum dosage of camphor and borneol was 73.32 mg·piece-1 and 123.72mg·piece-1 respectively. Conclusion: Some prohibited ingredients such as menthol, camphor and borneol weredetected in medical antipyretic paste medical devices on the market, which should be paid more attention to. |
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