The phytoequivalence of herbal extracts: A critical evaluation

被引:5
作者
Pace, Roberto [1 ]
Martinelli, Ernesto Marco [1 ]
机构
[1] Indena SpA, Via Don Minzoni 6, I-20049 Settala, MI, Italy
关键词
Phytoequivalence; Principal component analysis; PCA; Herbal extracts; Botanicals; QUALITY-CONTROL; METABOLOMICS; CHEMOMETRICS; ALIGNMENT; TOOL;
D O I
10.1016/j.fitote.2022.105262
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
The concept of phytoequivalence was developed in Germany in mid-1990 to indicate that a herbal extract is equivalent to another one, more specifically, to a clinically validated one. The pharmacological/physiological activity of an extract is related to its composition, but, due to the presence of many constituents, reliable technique are necessary to compare extracts. While the concept of equivalence among pure chemicals or isolated substances is feasible using the modern chromatographic and spectroscopic technology, specific guideline for herbal extracts or botanicals are still missing. This is mainly due to the multicomponent nature of the herbal extracts and to the natural variability of their constituents. Nevertheless, by using mathematical and/or che-mometric approaches, the concept of phytoequivalence can be precisely addressed, as exemplified by a series of examples that are discussed in detail. Helpful practical recommendations based on literature data and personal experience are presented.
引用
收藏
页数:20
相关论文
共 47 条
[1]   Chemometric-Guided Approaches for Profiling and Authenticating Botanical Materials [J].
Abraham, Evelyn J. J. ;
Kellogg, Joshua J. J. .
FRONTIERS IN NUTRITION, 2021, 8
[2]  
[Anonymous], 2021, EUROPEAN PHARMACOPOE
[3]  
[Anonymous], 2022, KOR GUID PHYT
[4]  
[Anonymous], 2011, EMACPMPQWP281900REV2
[5]   The correlation coefficient:: An overview [J].
Asuero, AG ;
Sayago, A ;
González, AG .
CRITICAL REVIEWS IN ANALYTICAL CHEMISTRY, 2006, 36 (01) :41-59
[6]  
Australian Government Department of Health Therapeutic Good Administration, 2011, GUID EQ HERB EXTR CO
[7]   A MATLAB toolbox for Principal Component Analysis and unsupervised exploration of data structure [J].
Ballabio, Davide .
CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS, 2015, 149 :1-9
[8]   Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements [J].
Barlow, Susan ;
Chesson, Andrew ;
Collins, John D. ;
Flynn, Albert ;
Galli, Corrado L. ;
Hardy, Anthony ;
Jany, Klaus-Dieter ;
Jeger, Michael-John ;
Knaap, Ada ;
Kuiper, Harry ;
Larsen, John-Christian ;
Lovell, David ;
Schlatter, Josef ;
Silano, Vittorio ;
Smulders, Frans ;
Vannier, Philippe .
EFSA JOURNAL, 2009, 7 (09)
[9]   Cross-validation of component models: A critical look at current methods [J].
Bro, R. ;
Kjeldahl, K. ;
Smilde, A. K. ;
Kiers, H. A. L. .
ANALYTICAL AND BIOANALYTICAL CHEMISTRY, 2008, 390 (05) :1241-1251
[10]   Principal component analysis [J].
Bro, Rasmus ;
Smilde, Age K. .
ANALYTICAL METHODS, 2014, 6 (09) :2812-2831