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Ensuring the safety of botanical dietary supplements.

机译:确保植物性膳食补充剂的安全性。

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摘要

Botanical dietary supplements with a history of safe human use may not require the same level of toxicity testing as synthetic pharmaceutical drugs. Most of the documented examples of acute toxicity caused by botanical dietary supplements have been caused by the substitution of toxic plants for the desired species, probably through misidentification or production errors, or by contamination with pharmaceutical agents, either as a result of poor manufacturing practices or adulteration. Although more difficult to document, chronic toxicities attributed to botanical dietary supplements may be caused by contamination by heavy metals, pesticides, or microbes or by inherent properties of constituents of the botanicals themselves. Like drug-drug interactions, botanical-drug interactions can also be a source of toxicity. Most of these toxicity problems may be prevented by implementing good agricultural practices and good manufacturing practices and applying existing toxicity testing similar to those used in drug development or new toxicity assays under development based on proteomics, genomics, or metabolomics.
机译:具有人类安全使用历史的植物膳食补充剂可能不需要与合成药物相同水平的毒性测试。大多数记录在案的植物膳食补充剂引起的急性毒性的例子都是由于有毒植物替代所需物种引起的,可能是由于识别错误或生产错误,或者是由于不良的制造实践或掺假导致的药物制剂污染。虽然更难记录,但归因于植物膳食补充剂的慢性毒性可能是由重金属、杀虫剂或微生物的污染或植物本身成分的固有特性引起的。与药物相互作用一样,植物药物相互作用也可能是毒性的来源。通过实施良好农业规范和良好生产规范,并应用与药物开发中使用的毒性测试或基于蛋白质组学、基因组学或代谢组学正在开发的新毒性测定类似的现有毒性测试,可以预防大多数毒性问题。

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