Unit of Pharmacology, Pharmacognosy and Therapeutics, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain; CAMAG Laboratory, Muttenz, Switzerland.
European Directorate for the Quality of Medicines & HealthCare (EDQM), European Pharmacopoeia Department, Council of Europe, Strasbourg, France.
Pharmeur Bio Sci Notes. 2021;2021:1-25.
Following a decision of the European Pharmacopoeia (Ph. Eur.) Commission, the Traditional Chinese Medicines (TCM) Working Party started a pilot phase to examine the suitability of a high-performance thin-layer chromatography (HPTLC) minimum content test as an alternative to the classical assay in TCM monographs. This approach was evaluated with two TCM herbal drugs: Fritillaria thunbergii bulbs (FTB) and Corydalis rhizome (CYR). Firstly, the existing HPTLC methods were optimised for both drugs. The new methods were applied to the evaluation of multiple samples, and acceptance criteria for the identification, following Ph. Eur. chapter 2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations, were set. The HPTLC test for minimum content of markers was then developed and validated. In this test, the intensity of the marker zone in the fingerprint of the sample is compared to the corresponding zone in the reference solution, which has a concentration giving an intensity equivalent to the acceptance criterion. This test gives a pass or fail result rather than a content and can be performed visually (on the images) or by software (using peak profiles from images; PPI). Reproducibility of the HPTLC methods was evaluated in a collaborative trial including six laboratories. In summary, results for FTB from five laboratories were in agreement. The remaining laboratory did not pass the identification of the samples. For CYR, all laboratories presented the same results for identification. In the test for minimum content, one borderline sample passed in four laboratories and failed in two. All laboratories reached similar conclusions for the other seven samples. The HPTLC methods proposed offer a simplified approach to evaluating identity and minimum content of TCM drugs in a single analysis.
在欧洲药典委员会（Ph. Eur.）的一项决定后，传统中药（TCM）工作组开始进行试点阶段，以检查高效薄层色谱（HPTLC）最低含量测试是否适合替代 TCM 专论中的经典测定方法。这种方法用两种 TCM 草药进行了评估：川贝母（FTB）和延胡索（CYR）。首先，对这两种药物的现有 HPTLC 方法进行了优化。将新方法应用于多个样本的评估，并按照 Ph. Eur. 第 2.8.25 章的要求设定了识别的验收标准。随后开发并验证了用于测定标记物最低含量的 HPTLC 测试。在该测试中，将样品指纹图谱中标记区域的强度与参考溶液中相应区域的强度进行比较，参考溶液的浓度使得强度与验收标准相当。该测试给出通过或失败的结果，而不是含量，并且可以通过目视（在图像上）或通过软件（使用来自图像的峰轮廓；PPI）进行。在包括六个实验室的协作试验中评估了 HPTLC 方法的重现性。总的来说，五个实验室的 FTB 结果一致。剩下的一个实验室未能通过样品的鉴定。对于 CYR，所有实验室的鉴定结果相同。在最低含量测试中，四个实验室的一个边缘样品通过，两个实验室的样品未通过。所有实验室对其他七个样品得出了类似的结论。所提出的 HPTLC 方法提供了一种简化的方法，可在单次分析中评估 TCM 药物的身份和最低含量。
