Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Ubierstraße 71 - 73, Bonn D-53173, Germany.
Phytomedicine. 2019 Jul;60:153003. doi: 10.1016/j.phymed.2019.153003. Epub 2019 Jun 29.
The European Pharmacopoeia as well as further legal provisions contain rules for the assessment of potential residues and contaminants in herbal substances and preparations used for the production of herbal medicinal products, e.g. for the assessment of pesticide residues, heavy metals and other elemental impurities, mycotoxins and microorganisms. As a potential contamination caused by weeds, the occurrence of pyrrolizidine alkaloids is being discussed for several years which lead to measures of health authorities limiting the PA content in herbal medicinal products and to measures of industry consisting of reducing the probability of PA occurrence in medicinal plants and the respective products.
In this context and with regard to all kinds of potential residues or contaminants, collection and evaluation of data from daily analytical practice of manufacturers and suppliers is useful for the assessment of the situation and the definition of testing strategies.
《欧洲药典》以及其他法律规定包含了用于评估草药物质和制剂中潜在残留和污染物的规则,例如用于评估农药残留、重金属和其他元素杂质、真菌毒素和微生物的规则。由于杂草可能造成的潜在污染,多年来一直讨论着是否存在吡咯里西啶生物碱,这导致了卫生当局采取措施限制草药药品中的 PA 含量,以及行业采取措施降低药用植物和相应产品中 PA 出现的可能性。
在这种情况下,对于各种潜在的残留或污染物,收集和评估制造商和供应商日常分析实践的数据对于评估情况和制定测试策略是有用的。