Khan Ikhlas A
National Center for Natural Products Research and Research Institute of Pharmaceutical Sciences, Department of Pharmacognosy, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
Life Sci. 2006 Mar 27;78(18):2033-8. doi: 10.1016/j.lfs.2005.12.019. Epub 2006 Feb 17.
Herbal product studies cannot be considered scientifically valid if the product tested was not authenticated and characterized in order to ensure reproducibility in the manufacturing of the product in question. Many studies refer to the use of standardized material, but in reality they are referring to chemical standardization. While chemical standardization is important, its utility is limited when the starting material is not well characterized botanically. Although the resulting studies are sound with respect to the actual product tested, adequate authentication of the product cannot be compared to other products on the market. Also, a comparison of one study to another cannot be made due to inconsistencies in the identity of the botanical matrix. The tools needed for authentication of the field plant material also depend on the plant and process involved. This could be as straightforward as botanical/morphological identification or as elaborate as genetic or chemical profiling. Authenticated raw material is the basic starting point for the development of a botanical product. However, harvesting, storing, processing and formulating methods may dramatically affect the quality and consistency of the final product by altering the desired marker components or by increasing the possibility of unwanted contaminants. Thus, validated methods to ensure quality control in manufacturing and storage are required tools for optimal efficacy and safety of the products. These controls are also critical for the evaluation of pharmacological, toxicological and clinical studies of the botanical supplements.
如果所测试的草药产品没有经过鉴定和特性描述，以确保所涉产品生产的可重复性，那么草药产品研究就不能被认为具有科学有效性。许多研究提到使用标准化材料，但实际上它们指的是化学标准化。虽然化学标准化很重要，但当起始材料在植物学上没有得到很好的特性描述时，其效用是有限的。尽管就所测试的实际产品而言，所得研究是可靠的，但该产品的充分鉴定无法与市场上的其他产品进行比较。此外，由于植物基质身份的不一致，一项研究与另一项研究也无法进行比较。鉴定田间植物材料所需的工具也取决于所涉及的植物和工艺。这可能像植物学/形态学鉴定一样简单，也可能像基因或化学分析一样复杂。经过鉴定的原材料是植物产品开发的基本起点。然而，收获、储存、加工和配方方法可能会通过改变所需的标记成分或增加不需要的污染物的可能性，极大地影响最终产品的质量和一致性。因此，确保生产和储存过程中质量控制的有效方法是实现产品最佳疗效和安全性所需的工具。这些控制对于评估植物补充剂的药理学、毒理学和临床研究也至关重要。
