Upton Roy T
American Herbal Pharmacopoeia, P.O. Box 66809, Scotts Valley, CA 95067, USA.
J AOAC Int. 2010 Sep-Oct;93(5):1349-54.
TLC characterizations are among the key identity tests in most pharmacopoeial monographs. Pharmacopoeial standards are typically used by industry as a basis for meeting QC requirements and current good manufacturing practices (cGMPs). TLC is a relatively low-cost, highly versatile tool for developing specifications for raw materials, as well as for the various preparations for which pharmacopoeial standards are created. In addition to its use in the development of identity tests, TLC is a valuable tool for screening plant samples that pharmacopoeias must review in the development of monographs and botanical reference materials (BRMs). Specifically, HPTLC is the ideal TLC technique for these purposes because of its increased accuracy, reproducibility, and ability to document the results, compared with standard TLC. Because of this, HPTLC technologies are also the most appropriate TLC technique for conformity with GMPs. This article highlights the manner in which HPTLC is used by the American Herbal Pharmacopoeia (AHP) in the development of AHP monograph identity standards, the identification of adulterating species, and the development of AHP-verified BRMs.
薄层色谱（TLC）表征是大多数药典专论中的关键鉴别试验之一。行业通常将药典标准用作满足质量控制要求和现行良好生产规范（cGMP）的基础。TLC是一种相对低成本、用途广泛的工具，可用于制定原材料的规格以及创建药典标准的各种制剂。除了用于鉴别试验的开发外，TLC还是筛选植物样品的宝贵工具，药典在制定专论和植物参考物质（BRM）时必须对这些植物样品进行审查。具体而言，与标准TLC相比，高效薄层色谱（HPTLC）由于其更高的准确性、重现性以及记录结果的能力，是用于这些目的的理想TLC技术。因此，HPTLC技术也是最符合GMP的TLC技术。本文重点介绍了美国草药药典（AHP）在制定AHP专论鉴别标准、鉴定掺假物种以及开发经AHP验证的BRM时使用HPTLC的方式。
