Herbal weight loss drugs are becoming more widely used in the fight against obesity, but ineffective regulation of these products have resulted in harmful additives. These products may contain adulterants such as sibutramine hydrochloride that may result in serious adverse health events including death. This work established a color precipitation reaction-based rapid screening method for illegal adulteration of sibutramine hydrochloride in natural herbal medicines (NHM) and dietary supplements (DS). While a variety of chromatography- and electrophoresis-based systems have been reported to measure this analyte, they generally suffer from high costs, complicated sample preparation, and a costly analytical infrastructure. In contrast, we present a simple, handheld kit to assay for sibutramine. The performance metrics of this tool include an average detection time of approximately 3 minutes, which is markedly shorter than conventional methods (HPLC or HPLC-MS, etc.), a detection limit of 0.1 mg per aliquot, and an accuracy of 99.02% (n = 820). More strikingly, the sensitivity is 100% (n = 278), and the specificity is 98.52% (n = 542). The rapid test kit developed from this screening method was evaluated by FDA. In summary, this screening method is a rapid, simple, and low-cost tool for the detection of sibutramine in NHM and DS with superior selectivity and sensitivity. For these reasons, this method is especially suitable for underdeveloped settings because it can be employed onsite without any instrumentation. In addition, this approach could rapidly exclude most of the negative samples to boost efficiency in large-scale samples assay. If necessary, positive samples can undergo further alternate testing methods to confirm the positive results of sibutramine hydrochloride content.

中文翻译：

---

天然草药和膳食补充剂中盐酸西布曲明的快速筛选方法

草药减肥药在对抗肥胖方面的应用越来越广泛，但对这些产品的无效监管导致了有害的添加剂。这些产品可能含有掺杂物，如盐酸西布曲明，可能导致严重的不良健康事件，包括死亡。本工作建立了一种基于颜色沉淀反应的天然草药（NHM）和膳食补充剂（DS）中非法掺假盐酸西布曲明的快速筛查方法。虽然已经报道了各种基于色谱和电泳的系统来测量这种分析物，但它们通常存在成本高、样品制备复杂和分析基础设施昂贵的问题。相比之下，我们提供了一个简单的手持式试剂盒来检测西布曲明。n  = 820）。更引人注目的是，敏感性为 100% ( n  = 278)，特异性为 98.52% ( n  = 542)。由这种筛选方法开发的快速检测试剂盒通过了 FDA 的评估。总之，该筛选方法是一种快速、简单且低成本的工具，用于检测 NHM 和 DS 中的西布曲明，具有卓越的选择性和灵敏度。由于这些原因，这种方法特别适用于欠发达的环境，因为它可以在现场使用而无需任何仪器。此外，这种方法可以快速排除大部分阴性样本，以提高大规模样本分析的效率。如有必要，阳性样品可以进行进一步的替代测试方法，以确认盐酸西布曲明含量的阳性结果。