Sudberg Sidney, Sudberg Elan M, Terrazas Jennifer, Sudberg Sandra, Patel Kirtal, Pineda Jose, Fine Bryan
Alkemists Laboratories, 1260 Logan Ave, Suite B-2, Costa Mesa, CA 92626, USA.
J AOAC Int. 2010 Sep-Oct;93(5):1367-75.
There are many examples of botanical identity methodology currently in use today; all have associated levels of confidence and, hence, application for their intended purpose. This paper addresses the application of some of these methods to identify and qualify commonly traded herbs. The relevance of botanical identity and quality within the dietary supplement industry has seen a dramatic increase in the last several years, and now with the current Good Manufacturing Practices (cGMPs) recently published and the requirement for 100% identity testing, there is an increased need for reliable methods of analysis and subsequent interpretation of the results or data derived from these methods, given the diversity of samples and matrixes seen on a daily basis in a commercial setting. Example applications of methods described herein illustrate how one can confidently and effectively satisfy the 100% identity rule of the cGMPs to identify crude raw materials and their powdered or liquid extracts as well as identify a majority of such ingredients in finished products with diverse matrixes. The three techniques discussed in this paper are viewed from a qualitative perspective with primary emphasis on the application of HPTLC to a variety of complex samples with varying degrees of difficulty of analysis and interpretation. The three methods discussed are (1) HPTLC, for its fingerprint/pattern recognition capabilities as well as marker compound analysis; (2) microscopy, for identification/recognition of unique cellular, anatomic features and characteristics of the target plant or adulterants; and (3) HPLC for marker compound identification, quantitation, and/or other fingerprint qualities it may contribute to the data set. To support the applications and methods described herein, this paper presents four key approaches to assist in the interpretation of the data collected in order to correctly determine the identity of botanicals and their powdered extracts: the "marker approach," the "multicomponent-based approach", the "pattern approach," and the "multipattern approach", and how these approaches can be used with a vanguard/rearguard strategy in analytical testing as well as forming a basis for the "functional fingerprint" and the concept of phytoequivalence.
目前有许多植物鉴定方法在当今被广泛应用；所有这些方法都有相应的置信水平，因此也适用于其预期目的。本文探讨了其中一些方法在鉴定和验证常见贸易草药方面的应用。在过去几年中，植物鉴定和质量在膳食补充剂行业中的相关性显著增加，现在随着最近发布的现行良好生产规范（cGMPs）以及100%鉴定测试的要求，鉴于在商业环境中每天看到的样品和基质的多样性，对可靠的分析方法以及对这些方法所得结果或数据的后续解读的需求日益增加。本文所述方法的示例应用说明了如何自信且有效地满足cGMPs的100%鉴定规则，以鉴定粗原料及其粉末或液体提取物，以及鉴定成品中具有不同基质的大多数此类成分。本文从定性角度讨论了三种技术，主要强调了高效薄层色谱法（HPTLC）在各种分析和解读难度不同的复杂样品中的应用。所讨论的三种方法分别是：（1）HPTLC，因其指纹/模式识别能力以及标记化合物分析；（2）显微镜检查，用于识别/辨认目标植物或掺假物独特的细胞、解剖特征；（3）高效液相色谱法（HPLC）用于标记化合物鉴定、定量和/或它可能为数据集提供的其他指纹特征。为了支持本文所述的应用和方法，本文提出了四种关键方法来协助解读所收集的数据，以便正确确定植物及其粉末提取物的身份：“标记物方法”、“基于多成分的方法”、“模式方法”和“多模式方法”，以及这些方法如何在分析测试中与先锋/后卫策略一起使用，以及如何形成“功能指纹”和植物等效性概念的基础。
