Berman Alyssa R, Birkenheuer Adam J, Sorah Emily L, Papich Mark G
Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA.
Veterinary Hospital Pharmacy, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA.
J Vet Pharmacol Ther. 2025 Jan;48(1):56-60. doi: 10.1111/jvp.13480. Epub 2024 Aug 24.
Oral artemisinin has antiparasitic activity and may help improve treatment success rates in dogs infected with Babesia gibsoni. However, these artemisinin products are unapproved and unregulated botanical supplements. They have not been evaluated for safety and efficacy or for strength, purity, or quality compared with a reference standard. Before considering these products for a clinical study, we evaluated the strength of four suppliers of artemisinin capsules using an high-performance liquid chromatography method validated in our laboratory. We found that the four artemisinin-labeled products that were tested had high within product and between product variability in capsule strength compared with the stated capsule strength on the product label. No products met the acceptance criteria of the United States Pharmacopeia and International Council for Harmonisation (ICH) as well as the criteria adapted by the authors. One product had no detectable artemisinin, and the other three products were much higher than the stated label strength. The results of this study reinforce the importance of testing unapproved and unregulated supplements before recommending a supplement for clinical use in dogs.
口服青蒿素具有抗寄生虫活性，可能有助于提高感染吉氏巴贝斯虫的犬类的治疗成功率。然而，这些青蒿素产品是未经批准和监管的植物性补充剂。与参考标准相比，它们尚未进行安全性、有效性、强度、纯度或质量的评估。在考虑将这些产品用于临床研究之前，我们使用在我们实验室验证的高效液相色谱法评估了四家青蒿素胶囊供应商产品的强度。我们发现，与产品标签上标明的胶囊强度相比，所测试的四种标有青蒿素的产品在产品内部和产品之间的胶囊强度存在很大差异。没有产品符合美国药典和国际协调理事会（ICH）的验收标准以及作者采用的标准。一种产品未检测到青蒿素，其他三种产品的含量远高于标明的标签强度。这项研究的结果强化了在推荐未经批准和监管的补充剂用于犬类临床使用之前进行检测的重要性。
