但要求指明活性成份。实质上,仍以提纯制品为基调

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两种拿到许可的植物药,都是提纯的:http://www.medsci.cn/article/show_article.do?id=ba7e15635279

植物开发指南的中文解读:https://med.sina.cn/article_detail_103_2_36548.html 

FDA2016版:植物药开发指南 https://www.fda.gov/downloads/Drugs/Guidances/UCM458484.pdf

其第九页要求药物成分:

2. Botanical Drug Substance (§ 312.23(a)(7)(iv)(a))
The sponsor should provide the following information for the botanical drug substance,
regardless of whether it is prepared from one or more botanical raw materials:
• Qualitative description of the drug substance. It should include the name, appearance, active constituents, physicochemical properties, biological activity, and any prior clinical use of each botanical raw material used to prepare the drug substance. If the active constituents, biological activity, and/or prior clinical use are unknown, the application should clearly state this. For a multi-plant drug substance, the application should state whether the drug substance is prepared by combining individually processed botanical drug substances or processing combined botanical raw materials.
• Quantitative description of the drug substance. The strength of a botanical drug substance should generally be expressed as the absolute dry weight of a processed botanical substance. The batch size and yield of the process relative to the botanical raw material should be provided. When the active constituents or other chemical constituents are known and measurable, the amount in which they are present in the botanical drug

substance should be declared. The composition of multi-plant drug substances, in terms of the relative ratio of the individually processed botanical drug substances or of the botanical raw materials before processing (as applicable), should be expressed.

 

 

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