[關(guān)鍵詞]
[摘要]
為了解興奮劑相關(guān)中西藥復(fù)方制劑的含量控制現(xiàn)狀,對添加興奮劑相關(guān)化學(xué)成分的中西藥復(fù)方制劑質(zhì)量標準及說明書進行了分析。介紹了已被直接添加到中西藥復(fù)方制劑的7種興奮劑相關(guān)化學(xué)成分,梳理了269個有效批準文號,共涉及47個品種。得到的主要結(jié)論為添加興奮劑相關(guān)化學(xué)成分的中西藥復(fù)方制劑,其藥品規(guī)格或說明書中未能完全體現(xiàn)所含化學(xué)藥的含量,存在一定的安全隱患,特別在聯(lián)合用藥時,可能增加不良反應(yīng)風(fēng)險,同時可能導(dǎo)致運動員誤服興奮劑。建議對中西藥復(fù)方制劑中的化學(xué)藥成分及毒性成分進行控制,制定含量范圍,為進一步完善質(zhì)量標準和說明書提供參考,并充分引起醫(yī)藥行業(yè)對興奮劑相關(guān)問題的重視。
[Key word]
[Abstract]
In order to understand the content control status of combination drug of traditional Chinese medicine and pharmaceutical chemicals with stimulant related chemical constituents, the specifications and labeling of combination drug of traditional Chinese medicine and pharmaceutical chemicals with stimulant related chemical constituents were analyzed in this paper. The research includes the introduction of seven stimulus-related chemical constituents that have been directly added to the combination drug of traditional Chinese medicine and pharmaceutical chemicals, and the sorting out of 269 valid drug approval numbers, involving a total of 47 varieties. The main conclusion is that the combination drug of traditional Chinese medicine and pharmaceutical chemicals fails to fully reflect the content of the pharmaceutical chemicals contained in its drug specifications or labeling, and there are certain safety risks, especially in the combination of drugs, which may raise the risk of adverse reactions, and may lead to athletes taking stimulant by mistake. It is suggested to control the chemical and toxic constituents in the combination drug of traditional Chinese medicine and pharmaceutical chemicals, and establish the content range, so as to provide reference for further improving the specifications and labeling. Therefore, the pharmaceutical industry should pay more attention to the issues related to stimulant.
[中圖分類號]
[基金項目]