从健美运动员黑市查获的假药和制剂

Vera Coopman, J. Cordonnier
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引用次数: 26

摘要

目的:本研究的目的是确定有效成分存在于假药和药物制剂缉获从黑市健美运动员。对不同批号的封闭或密封包装制剂(n = 74)和两种未加标签的制剂进行分析。方法:采用反相液相色谱-光电二极管阵列紫外检测器和气相色谱-质谱联用技术进行鉴别。采用ChromSpher 5 C18色谱柱,以磷酸三乙胺和乙腈为流动相,分别在220 nm和254 nm波长下对片剂、胶囊、口服果冻和水基注射剂的甲醇样品提取物进行色谱分析。用己烷和甲醇萃取油基注射剂(n = 41)。甲醇样品提取液和稀释后的上清层注入Agilent 6890 N气相色谱仪,采用熔融石英CPSIL 8CB低流量毛细管柱和Agilent 5973惰性质量选择检测器,全扫描模式工作。已鉴定的化合物与标签上声明的有效成分进行了对照检查。结论:地下实验室生产的假药包装与合法制药公司生产的假药包装在视觉上无法区分。在74个标签产品中,有25个(33.8%)的含量与标签不符。合成代谢雄激素类固醇通常在黑市上的健美运动员中被发现,主要是在油基注射剂中酯化。在40种甾体油溶液中,21种(52.5%)的有效成分与标签不符:一种制剂不含活性化合物,20种含有其他或更多活性成分。这些额外的化合物通常数量较少,这可能表明受到了污染。在片剂、口服果冻和水基注射剂中检出了美雄烯酮、西地那非、他莫昔芬、奎宁、克罗米芬、脱氢表雄酮、阿纳唑、克仑特罗、斯坦诺唑尔、奥雄龙、碘甲状腺原氨酸、非那雄胺和褪黑激素等有效成分。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Counterfeit drugs and pharmaceutical preparations seized from the black market among bodybuilders
Objectives: The aim of this study was to identify active ingredients present in counterfeit drugs and pharmaceutical preparations seized from the black market among bodybuilders. Preparations in closed or sealed packaging with different batch numbers ( n  = 74) and two preparations without labels were analyzed. Methods: The identification scheme was based on reversed-phase liquid chromatography with a photodiode array UV detector and gas chromatography-mass spectrometry. Methanolic sample extracts of tablets, capsules, oral jellies and water–based injectables were chromatographed on a ChromSpher 5 C18 column using a gradient program of triehylammonium phosphate and acetonitrile as mobile phases and were monitored at the wavelengths 220 nm and 254 nm. Oil-based injectables ( n  = 41) were extracted with hexane and methanol. The methanolic sample extracts and diluted supernatant layers were injected into an Agilent 6890 N gas chromatograph with a fused silica CPSIL 8CB low-bleed capillary column and Agilent 5973 inert mass selective detector operated in full-scan mode. The identified compound(s) were checked against the active ingredient(s) declared on the label. Conclusion: Packaging from counterfeits produced in underground labs cannot be visually distinguished from packaging originating from legitimate pharmaceutical companies. Out of 74 labeled products, the content of 25 (33.8%) did not match the label. Anabolic androgenic steroids are commonly found on the black market among bodybuilders, predominately esterified in oil-based injectables. Out of 40 steroidal oily solutions, the active ingredients of 21 (52.5%) did not match the label: one preparation did not contain an active compound, 20 contained other or more active ingredients. The additional compounds were often present in smaller quantities, which could be indicative of contamination. Active ingredients such as methandrostenolone, sildenafil, tamoxifen, quinine, clomiphene, dehydroepiandrosterone, anastrazole, clenbuterol, stanozolol, oxandrolone, liothyronine, finasteride and melatonin were identified in tablets, oral jellies and water-based injectables.
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