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Research Progress of Illegally Added Chemical Medicines and Detection in Chinese Patent Medicines and Health Foods for Regulating Three-Hypers
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摘要: 高血糖、高血压、高血脂统称为"三高症", 现在已经成为威胁人们身体健康的常见疾病. 具有调节"三高症"作用的保健食品和中成药越来越频繁地应用于此类疾病的日常预防及治疗. 然而有不法分子为谋取利益, 向其中违规添加化学药物, 对患者造成安全隐患. 针对调节"三高症"的中成药和保健食品中非法添加化学药物的种类进行了总结, 并对此类非法添加药物的国家标准补充检验方法及其他学者的检测分析方法研究情况进行了综述, 最后根据目前非法添加现状分析了进一步的研究方向, 以期为非法添加检测工作提供参考.Abstract: Hyperglycemia, hypertension and hyperlipemia, collectively known as the "three-hypers", have already become the common diseases that threaten people's health. Chinese patent medicines and health food are more and more frequently used in the daily prevention and treatment of these diseases. However, some chemical substances have been illegally added for profit, causing safety hazards to patients. The types of illegally added chemical medicines in Chinese patent medicines and health foods that regulate "three-hypers" in recent years were summarized, and the research situation of the national standard supplementary testing methods and other analysis methods for these of illegally added medicines were introduced. Finally, according to the current situation of illegal addition, further research directions are analyzed in order to provide reference for the detection on illegal addition.
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Key words:
- three-hypers /
- illegal medicines addition /
- Chinese patent medicine /
- health food
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表 1 降血压类代表性化学药物
Table 1. Typical chemical medicines for antihypertensive
药物类型 代表性化学药物 利尿剂 氢氯噻嗪、螺内酯、吲达帕胺、呋塞米 β受体阻滞剂 美托洛尔、卡维地洛、比索洛尔、阿替洛尔、普萘洛尔 α受体阻滞剂 哌唑嗪、特拉唑嗪、布那唑嗪、多沙唑嗪、妥拉唑林、甲磺酸酚妥拉明 钙拮抗剂 硝苯地平、氨氯地平、乐卡地平、尼莫地平、尼卡地平、尼群地平、尼索地平、非洛地平、贝尼地平、拉西地平、维拉帕米、地尔硫卓、氟桂利嗪、桂利嗪、利多氟嗪 血管紧张素转换酶抑制剂 卡托普利、依那普利、赖诺普利、培哚普利、雷米普利、贝那普利、咪达普利、福辛普利 血管紧张素受体拮抗剂 氯沙坦、缬沙坦、厄贝沙坦、坎地沙坦酯、他索沙坦、依普罗沙坦、替米沙坦 交感神经抑制剂 可乐定、利血平、甲基多巴 
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表 2 降血脂类代表性化学药物
Table 2. Typical chemical medicines for lipid-lowering
药物类型 代表性化学药物 他汀类 洛伐他汀、阿托伐他汀、瑞舒伐他汀、匹伐他汀、辛伐他汀、普伐他汀 贝特类 非诺贝特、苯扎贝特、吉非贝齐、氯贝特 胆固醇吸收抑制剂类 依折麦布 烟酸类 阿西莫司、普罗布考
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表 3 降血糖类代表性化学药物
Table 3. Typical chemical medicines for anti-diabetic
药物类型 代表性化学药物 磺酰脲类 甲苯磺丁脲、格列本脲、格列齐特、格列吡嗪、格列美脲、格列喹酮、格列波脲、氯磺丙脲、妥拉磺脲 非磺酰脲类 瑞格列奈、那格列奈、米格列奈 双胍类 二甲双胍、苯乙双胍、丁二胍 α-葡萄糖苷酶抑制剂 阿卡波糖、伏格列波糖 胰岛素增敏剂 罗格列酮、吡格列酮 二肽基肽酶-4抑制剂 西格列汀、阿格列汀、维格列汀、利格列汀、沙格列汀 GLP-1受体激动剂 艾塞那肽、贝拉鲁肽、利拉鲁肽、洛塞那肽 醛糖还原酶抑制剂 依帕司他
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表 4 国家批准补充检验方法涉及的非法添加化学药物及其分析条件
Table 4. Illegal additional chemical medicines and chromatographic analytical conditions involved in nation approved supplementary test method
批准件号 药品名称 检测化学药物成分 色谱分析条件 2009032 降压类中成药 阿替洛尔、盐酸可乐定、氢氯噻嗪、卡托普利、哌唑嗪、利血平、硝苯地平 C18柱(4.6 mm×250 mm，5 μm)；流动相：乙腈-0.2%磷酸，梯度洗脱；流速1.0 mL/min；进样量10 μL；柱温35 ℃；检测波长220 nm [13]. 2014008 降压类中成药和辅助降血压类保健食品 氨氯地平、硝苯地平、尼群地平、尼莫地平、尼索地平、非洛地平 C18柱(4.6 mm×250 mm，5 μm)；流动相：乙腈-0.2%磷酸，梯度洗脱；进样量10 μL；检测波长220 nm [14]. 2009029 降糖类中成药 (1)甲苯磺丁脲、格列本脲、格列齐特、格列吡嗪、格列喹酮、格列美脲、马来酸罗格列酮、瑞格列奈、盐酸吡格列酮；(2)盐酸二甲双胍、盐酸苯乙双胍 (1)C18柱(4.6 mm×250 mm，5 μm)；流动相：甲醇-0.01 mol/L乙酸铵，梯度洗脱；进样量10 μL；检测波长235 nm；(2)C18柱(4.6 mm×250 mm，5 μm)；流动相：甲醇-庚烷磺酸钠溶液，梯度洗脱；进样量5 μL；检测波长235 nm [15]. 2011008 降糖类中成药 盐酸丁二胍 C18柱(4.6 mm×250 mm，5 μm)；流动相：甲醇-庚烷磺酸钠溶液，梯度洗脱；流速1.0 mL/min；进样量10 μL；柱温35 ℃；检测波长235 nm [16]. 2013001 降糖类中成药和保健食品 格列波脲 C18柱(4.6 mm×250 mm，5 μm)；流动相：甲醇-0.01 mol/L乙酸铵，梯度洗脱；进样量10 μL；检测波长235 nm [17]. 食药监办许2010[114号] 辅助降血脂类保健食品 洛伐他汀、辛伐他汀、烟酸 C18柱；流动相：甲醇-20 mmol/L乙酸铵，梯度洗脱；流速1.0 mL/min；进样量10 μL；柱温35 ℃；进样量10 μL；检测波长235 nm [14].
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表 5 已发布研究成果涉及的非法添加化学药物及其分析条件
Table 5. Illegal additional chemical medicines and analytical conditions involved in published studies
成分作用 分析方法 检测化学药物成分 色谱分析条件 降血压 HPLC-DAD定量分析LC-MS/MS定性确证 阿替洛尔、卡托普利、氢氯噻嗪、盐酸普萘洛尔、氨苯蝶啶、硝苯地平、苯磺酸左旋氨氯地平、利血平、氯沙坦钾、替米沙坦、尼莫地平、尼群地平、坎地沙坦酯、缬沙坦、盐酸可乐定、甲磺酸多沙唑嗪、吲达帕胺、尼索地平、盐酸哌唑嗪、富马酸比索洛尔、非洛地平 Agilent Poroshell 120 Phenyl-Hexyl(100 mm×2.1 mm，2.7 μm)；流动相：A为甲醇∶乙腈(2∶1)，B为甲酸水溶液(pH值为2.5±0.1)，梯度洗脱；流速0.8 mL/min；柱温40 ℃；进样量10 μL；检测波长215、270、350 nm [26]. LC-QTOF/MS 贝那普利、盐酸贝那普利、硝苯地平、尼群地平、尼莫地平、吲达帕胺、氯沙坦钾、缬沙坦、坎地沙坦酯、酒石酸美托洛尔、卡维地洛、盐酸普萘洛尔、阿替洛尔、利血平、盐酸哌唑嗪、甲磺酸多沙唑嗪、盐酸特拉唑嗪、盐酸妥拉唑林 Agilent Eclipse plus C18(50 mm×2.1 mm，1.8 μm)；流动相：0.5%甲酸水溶液-乙腈，梯度洗脱；流速0.2 mL/min；进样量1 μL；柱温30 ℃ [33]. 降血脂 UPLC-DAD 阿托伐他汀钙、苯扎贝特、非诺贝特、氟伐他汀钠、吉非罗齐、洛伐他汀、去羟基洛伐他汀、洛伐他汀羟酸钠、辛伐他汀、美伐他汀、普伐他汀钠、罗苏伐他汀钠 AgilentPoroshell 120 EC-C18(4.6 mm×100 mm，2.7 μm)；流动相：0.02 mol/L乙酸铵-甲醇，梯度洗脱；流速1.0 mL/min；进样量5 μL；柱温30 ℃；检测波长230 nm [25]. 降血糖 TLC 格列本脲、格列美脲、格列吡嗪、格列齐特、格列喹酮 GF 254薄层板，展开剂为氯仿∶环已烷∶乙醇∶冰醋酸(8∶12∶1∶1) [19]. TLC 二甲双胍、苯乙双胍 GF 254薄层板，展开剂为石油醚∶甲醇∶冰乙酸(5∶12∶0.5) [20]. HPLC-UV 二甲双胍、格列吡嗪、格列本脲、格列美脲 Shim-Pack VP-ODS柱(4.6 mm×250 mm，4.6 μm)；流动相：甲醇-0.02 mol/L磷酸二氢铵水溶液(pH值调节至3.0)，梯度洗脱；流速1.0 mL/min；进样量20 μL；柱温25 ℃；检测波长230 nm [22]. HPLC-DAD 阿卡波糖、盐酸二甲双胍、盐酸丁二胍、盐酸苯乙双胍、甲苯磺丁脲、妥拉磺脲、格列吡嗪、格列齐特、马来酸罗格列酮、格列波脲、盐酸吡格列酮、格列本脲、格列美脲、那格列奈、格列喹酮、瑞格列奈 C18柱(250 mm×4.6 mm，5 μm)；流动相：甲醇-0.01 mol/L乙酸铵溶液，梯度洗脱；流速1.0 mL/min；进样量10 μL；柱温30 ℃；检测波长210、235 nm [23]. HPLC-DAD 盐酸二甲双胍、盐酸丁二胍、盐酸苯乙双胍、格列吡嗪、格列齐特、马来酸罗格列酮、盐酸吡格列酮、格列本脲、格列美脲、格列喹酮、瑞格列奈、格列波脲、甲苯磺丁脲 Agilent Zorbax SB-C18(150 mm×2.1 mm，1.8 μm)；流动相：0.02 mol/L乙酸铵溶液-乙腈，梯度洗脱；流速0.2 mL/min；进样量2 μL；柱温35 ℃；检测波长235 nm，210~400 nm [24]. HPLC-DAD定量分析LC-MS/MS定性确证 甲苯磺丁脲、格列本脲、格列齐特、格列吡嗪、格列喹酮、格列美脲、马来酸罗格列酮、瑞格列奈、盐酸吡格列酮 岛津Wondasil C18-WR色谱柱(4.6 mm×250 mm，5 μm)；流动相：甲醇-0.01 mol/L乙酸铵溶液，梯度洗脱；流速1.0 mL/min；柱温35 ℃；检测波长235 nm [27]. LC-MS/MS 盐酸二甲双胍、盐酸苯乙双胍、盐酸罗格列酮、格列吡嗪、盐酸吡格列酮、格列齐特、格列波脲、格列本脲、格列美脲、格列喹酮、瑞格列奈、盐酸丁二胍、甲苯磺丁脲 岛津Inertsil ODS-SP色谱柱(150 mm×2.1 mm，5 μm)；流动相：10 mmol/L乙酸铵+0.1%甲酸水溶液-甲醇，梯度洗脱；流速0.2 mL/min；进样量10 μL；柱温35 ℃ [28]. LC-MS/MS 二甲双胍、苯乙双胍、罗格列酮、格列苯脲 Thermo BDSHypersil C8(2.1 mm×100 mm，2.4 μm)；流动相：A为0.2%甲酸水溶液，B为乙腈∶甲醇(6∶4)，梯度洗脱；流速0.3 mL/min；进样量5 μL；柱温30 ℃ [29]. UPLC-MS/MS 瑞格列奈、那格列奈、米格列奈、格列吡嗪、格列苯脲、格列美脲、格列喹酮、二甲双胍、甲苯磺丁脲、格列波脲、吡格列酮、吡咯齐特、苯乙双胍、罗格列酮 Agilent SB AQ柱(2.1 mm×100 mm，3.0 μm)；流动相：0.1%甲酸溶液-乙腈，梯度洗脱；流速：0.3 mL/min；进样量10 μL；柱温30 ℃ [31]. LC-QTOF/MS 盐酸二甲双胍、盐酸丁二胍、盐酸苯乙双胍、马来酸罗格列酮、盐酸吡格列酮、格列吡嗪、甲苯磺丁脲、瑞格列奈、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、格列喹酮 Thermo syncronis-C18色谱柱(150 mm×4.6 mm，5 μm)；流动相：0.1%甲酸水溶液-乙腈，梯度洗脱；流速0.3 mL/min；进样量5 μL；柱温30 ℃ [34]. 超高效液相色谱-静电场轨道肼高分辨质谱 西布曲明、格列本脲、尼莫地平等73种化学药物 WatersAcquity HSS T3 C18(2.1 mm×100 mm，1.8 μm)；流动相：乙腈-0.1%甲酸，梯度洗脱；流速：0.3 mL/min；进样量5 μL；柱温35 ℃ [35]. 降血脂、降血糖 LC-MS/MS 苯扎贝特、阿托伐他汀钙、吉非贝齐、洛伐他汀、辛伐他汀、非诺贝特、二甲双胍、苯乙双胍、阿卡波糖、吡格列酮、格列吡嗪、瑞格列奈、格列齐特、格列本脲、格列美脲、格列喹酮 C18柱(2.1 mm×150 mm，5 μm)；流速0.3 mL/min；进样量1 μL；柱温30 ℃. 流动相A(测定l-7)：20 mol/L醋酸铵溶液-乙腈，流动相B(测定8、9)：0.5%甲酸溶液-乙腈，流动相C(测定10-17)：0.5%甲酸溶液-乙腈[30]. 降血糖、降血脂、降血压 LC-MS/MS 格列本脲、盐酸二甲双胍、马来酸罗格列酮、盐酸苯乙双胍、格列齐特、甲苯磺丁脲、格列美脲、格列喹酮、瑞格列奈、格列波脲、盐酸吡格列酮、盐酸丁二胍、洛伐他汀、烟酸、辛伐他汀、美伐他汀、盐酸哌唑嗪、氢氯噻嗪、硝苯地平、卡托普利、盐酸可乐定、尼索地平、马来酸氨氯地平、尼莫地平、那格列奈、氯磺丙脲、氟伐他汀钠、苯扎贝特、非诺贝特、盐酸普萘洛尔、盐酸维拉帕米、米诺地尔、酒石酸美托洛尔、厄贝沙坦、布美他尼、盐酸尼卡地平、盐酸特拉唑嗪、富马酸比索洛尔、替米沙坦、格列吡嗪、阿替洛尔、利血平、非洛地平、尼群地平、去羟基洛伐他汀 Agilent Eclipse Plus C18柱(2.1 mm×100 mm，1.8 μm)；流动相：5 mmol/L乙酸铵溶液(用甲酸调节pH值至3.0)-乙腈，梯度洗脱；流速：0.2 mL/min；进样量1 μL；柱温35 ℃ [32].
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