Division of Advanced Analysis, Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, Chungcheongbuk-do 28159, Republic of Korea.
College of Pharmacy, Chung-Ang University, 84, Heukseok-ro, Dongjak-gu, Seoul 06974, Republic of Korea.
Forensic Sci Int. 2019 Oct;303:109932. doi: 10.1016/j.forsciint.2019.109932. Epub 2019 Aug 24.
With the increasing prevalence of obesity, the use of counterfeit drugs for weight loss is widespread owing to their easy and rapid availability. Since counterfeit weight-loss drugs are not prepared under the rigorous standard of Good Manufacturing Practice (GMP), they pose a risk to public health and cause significant side effects. To counteract the risk posed by counterfeit drugs, we investigated counterfeit weight-loss drugs seized by the Incheon Customs Services using UHPLC-PDA. Five of 23 confiscated samples with distinctive pink-coloured coating contained levothyroxine, sennoside A and B, and phenolphthalein in amounts ranging from 0.03-132.40 mg/g. In addition, three unknown compounds in one of the adulterated samples containing phenolphthalein were structurally elucidated by several analytical techniques. Their accurate masses corresponded to molecular formula of CHO, CHO, and CHO, respectively. These compounds were identified as impurities, possibly produced during the synthesis of phenolphthalein or by improper removal during purification. These impurities were detected for the first time in counterfeit drugs.
随着肥胖症的患病率不断上升，由于假冒减肥药易于获取且见效快，因此被广泛使用。由于假冒减肥药并非按照严格的《药品生产质量管理规范》（GMP）标准制备，因此它们对公众健康构成威胁，并会导致严重的副作用。为了应对假冒药品带来的风险，我们使用超高效液相色谱-光电二极管阵列（UHPLC-PDA）对仁川海关缉获的假冒减肥药进行了调查。在 23 个收缴样本中，有 5 个样本的粉红色涂层有明显特征，其含量范围在 0.03-132.40 毫克/克之间，含有甲状腺素、番泻苷 A 和 B 以及酚酞。此外，在一个含有酚酞的掺假样本中，有三个未知化合物的结构通过多种分析技术得到了阐明。它们的精确质量分别对应于 CHO、CHO 和 CHO 的分子式。这些化合物被鉴定为杂质，可能是在酚酞合成过程中产生的，也可能是在提纯过程中没有适当去除而产生的。这些杂质是首次在假冒药品中被检测到。
