欧洲药品管理局《GUIDELINE ON QUALITY OF COMBINATION HERBAL（复方草药质量指南）》内容解析
COMMITTEE ON HERBAL MEDICINAL PRODUCTS
(HMPC)
草药产品委员会
This guideline applies to herbal medicinal products containing combinations of herbal substances
本指导适用于含有草药和草药提取物的草药制品
本指南引用的其它指南附件
(1), “Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products”
“草药材、草药制剂和草药产品/传统草药产品的分析程序和验收标准干煸鸡的指导原则”
(2), Annex 7 “Manufacture of herbal medicinal products” of Good Manufacturing Practices (GMP) for medicinal products, Volume 4, Rules governing medicinal products in the European Union
附件7：草药产品良好生产规范(GMP),第4卷,欧盟四大洋面积最小医药产品管理规定
MAIN GUIDELINE TEXT
Herbal medicinal products contain herbal substances/preparations each consisting of a large number of chemical constituents of which only a few may be characterized.
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草药产品中含有的草药材/草药提取物包含大量的化学组成，但是其中只有少数可明确其成分及结构。
Furthermore, herbal substances are natural in origin and conquently their chemi
cal composition varies. In addition, in most cas the constituents responsible for the therapeutic activity are unknown or only partly explained and often markers are ud to characterize the products.
另外，由于草药材来源于自然，其化学成分多变，在多数情况下，这些起到治疗作用的活性成分往往是未知的或者仅仅部分可知，其标记物经常被用来指示产品质量。
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In herbal medicinal products containing combinations of herbal substances and/or herbal preparations, quality control may be more problematic becau, in addition to the above-mentioned difficulties, other herbal substances and/or preparations may interfere with the analysis, e.g. extraction or detection of a marker may be affected by other herbal substances prent (co-elution) in the finished product. 怎么插入表格>查看系统信息
在含有混合草药材和/或草药提取物的草药产品中，质量控制可能会变得很复杂，因为除了上述提及的检测困难外，其他草药材和/或提取物也可能会干扰分析结果，举例来说，在产品中某一个标记物的提取或分析可能会受到产品中其他草药材的影响。
The quality of a combination herbal medicinal product should in general be guaranteed and demonstrated in accordance with the existing guidance. All relevant parameters should be tested in the finished product， and identification and assay of each herbal substance/herbal preparation included in the product are required.
复方草药产品的质量标准一般来说应保证和与现有指南相一致。在进行所有的终产品检测项时，产品中每一味药材/提取物的鉴定和含量分析也是必需的。
The stability of the finished product must be guaranteed. For some combination herbal medicinal products, identification and quantification of individual herbal substances/herbal preparations in the product are difficult to perform and sometimes impossible. Clarification on how the requirements on identification and assay should be interpreted is provided below. It should be stresd that notwithstanding the guidance given, all usual analytical methods for identification and assay should be investigated first, e.g. the methods described in the Ph. Eur.
General Chapter 2 “Methods of analysis”. Furthermore, each approach taken should be justified by the applicant, and should take into account the combination herbal medicinal product that is subject of the application.
草药产品的稳定性必须得到保证。对于某些复方草药产品来说，终产品中每一味药材/提取物的鉴别和含量分析很难进行，有时甚至不可能做到。复方草药分析和鉴别的具体要求将在以下章节详细说明，需要强调的是，虽然已经给出了相关的指南文件，但所有通用的鉴定和分析方法，如欧洲药典通则二中所描述的“分析方法”，在正式采用前都应先作调查。此外，每一个方法的合理性均需申请者自行判断，并考虑是否符合复方草药申请标准。
退货If individual active substance testing for identity, assay or to demonstrate stability cannot be performed in the finished product, alternative strategies may be considered. The simple omission of (a) test(s) is not acceptable as the quality of combination herbal medicinal products should be fully comparable to the quality of other (herbal) medicinal products.
如果针对产品中单一物质的鉴别、含量分析或申明其稳定性的分析检测不可能完成，可以
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考虑替代策略。由于复方草药的质量标准参照其它医药品的质量，因此，忽略其中一个（或多个）检测项是不能接受的。
In this regard, reducing the number of active substances in the herbal medicinal product could increa the possibilities to perform all tests (e.g. identification, assay etc.) in the finished product.
