Improved Chromatographic Assessment of Chinese Medicinal Products by Multi-Chemical Classes Analysis

Abstract

An improved strategy for the quality evaluation of proprietary Chinese medicines (PCM) in complex matrices is presented. It involves the simultaneous separating and displaying of multi-chemical classes and analytes within a single chromatographic elution. The developed fingerprints have the properties of better coverage of multi-chemical classes among the composing herbs. This comprehensive and more facile approach was illustrated for Lemai Keli, a commonly used PCM listed in the Chinese Pharmacopoeia with highly complex analytical matrices. Ten marker compounds belonging to monoterpene glycosides, chalcone glycosides, phenolic acids and phenolic carboxylic aldehyde groups of the analytes together with three common chromatographic peaks were successively separated and displayed within the chromatographic window as a unique HPLC‐PAD fingerprint. Rigorous method validation data demonstrated the suitability of the current method for quality assessment purposes in a highly complex PCM matrix. Additional chemometric treatment further demonstrated the uniqueness of the developed fingerprint, with a distinctive chemical profile compared to a highly similar PCM formulation (Kangen Karyu) from which it was considered to be impossible to differentiate when using the conventional single marker approach.

proprietary Chinese medicine - fingerprinting - Lemai keli - high performance liquid chromatography

References

• 1 Liu Y, Yang J S, Cai Z W. Chemical investigation on Sijunzi decoction and its two major herbs Panax ginseng and Glycyrrhiza uralensis by LC/MS/MS.  J Pharm Biomed Anal. 2006;  41 1642-1647
• 2 Wang Y, Kong L, Hu L H, Lei X Y, Yang L, Chou G X, Zou H F, Wang C H, Bligh S WA, Wang Z T. Biological fingerprinting analysis of the traditional Chinese prescription Longdan Xiegan decoction by on/off-line comprehensive two-dimensional biochromatography.  J Chromatogr B. 2007;  860 185-194
• 3 Sheng Y X, Li L, Wang C S, Li Y Y, Guo D. Solid-phase extraction-liquid chromatographic method for the determination and pharmacokinetic studies of albiflorin and paeoniflorin in rat serum after oral administration of Si-Wu decoction.  J Chromatogr B. 2004;  806 127-132
• 4 Leung K SY, Chan K, Bensoussan A, Munroe A J. Application of atmospheric pressure chemical ionisation mass spectrometry in the identification and differentiation of Panax species.  Phytochem Anal. 2007;  18 146-150
• 5 Qian G S, Leung S K, Lu G H, Leung K SY. Optimization and validation of a chromatographic method for the simultaneous quantification of six bioactive compounds in Rhizoma Et Radix polygoni cuspidati.  J Pharm Pharmacol. 2008;  60 107-113
• 6 Gong F, Liang Y Z, Xie P S, Chau F T. Information theory applied to chromatographic fingerprint of herbal medicine for quality control.  J Chromatogr A. 2003;  1002 25-40
• 7 Chinese Pharmacopoeia Commission .The Chinese Pharmacopoeia. Beijing; Chemical Industry Press 2005
• 8 Di X, Chang K KC, Leung H W, Huie C W. Fingerprint profiling of acid hydrolyzates of polysaccharides extracted from the fruiting bodies and spores of Lingzhi by high-performance-thin-layer chromatography.  J Chromatogr A. 2003;  1018 85-95
• 9 Xie P S, Chen S B, Liang Y Z, Wang X H, Tian R T, Upton R P. Chromatographic fingerprint analysis – a rational approach for quality assessment of traditional Chinese herbal medicine.  J Chromatogr A. 2006;  1112 171-180
• 10 Zhao J, Zhang X Q, Li S P, Yang F Q, Wang Y T, Ye W C. Quality evaluation of Ganoderma through simultaneous determination of nine triterpenes and sterols using pressurized liquid extraction and high performance liquid.  J Sep Sci. 2006;  29 2609-2615
• 11 Yu R, Ye B, Yan C, Song L, Zhang Z, Yang W, Zhao Y. Fingerprint analysis of fruiting bodies of cultured Cordyceps militaris by high-performance liquid chromatography photodiode array detection.  J Pharm Biomed Anal. 2007;  44 818-823
• 12 Xie Y, Jiang Z H, Zhou H, Xu H X, Liu L. Simultaneous determination of six Aconitum alkaloids in proprietary Chinese medicines by high-performance liquid chromatography.  J Chromatogr A. 2005;  1093 195-203
• 13 Piao X L, Park J H, Cui J, Kim D H, Yoo D H. Development of gas chromatographic/mass spctrometry-pattern recognition method for the quality control of Korean Angelica.  J Pharm Biomed Anal. 2007;  44 1163-1167
• 14 Ruan G H, Li G K. The study on the chromatographic fingerprint of Fructus Xanthii by microwave assisted extraction coupled with GC‐MS.  J Chromatogr B. 2007;  850 241-253
• 15 Ding B, Zhou T T, Fan G R, Hong Z Y, Wu Y T. Qualitative and quantitative determination of ten alkaloids in traditional Chinese medicine Corydalis yanhusuo W.T. Wang by LC‐MS/MS and LC‐DAD.  J Pharm Biomed Anal. 2007;  45 219-226
• 16 Liu A H, Guo H, Ye M, Lin Y H, Sun J H, Xu M, Guo D A. Detection, characterization and identification of phenolic acids in danshen using high-performance liquid chromatography with diode array detection and electrospray ionization mass spectrometry.  J Chromatogr A. 2007;  1161 170-182
• 17 Zhou D Y, Xu Q, Xue X Y, Zhang F F, Liang X M. Identification of O-diglycosyl flavanones in Fructus Aurantii by liquid chromatography with electrospray ionization and collision-induced dissociation mass spectrometry.  J Pharm Biomed Anal. 2006;  42 441-448
• 18 Petsalo A, Jalonen J, Tolonen A. Identification of flavonoids of Rhodiola rosea by liquid chromatography-tandem mass spectrometry.  J Chromatogr A. 2006;  1112 224-231
• 19 Satoh A, Yokozawa T, Cho E J, Okamoto T, Sei Y. Antioxidative effects related to the potential anti-aging properties of the Chinese prescription Kangen-karyui and Carthami Flos in senescence-accelerated mice.  Arch Gerontol Geriatr. 2004;  39 69-82
• 20 Jiang W Y. Therapeutic wisdom in traditional Chinese medicine: a perspective from modern science.  Trends Pharm Sci. 2005;  26 558-563
• 21 Qiu J. Traditional medicine: A culture in the balance.  Nature. 2007;  448 126-128
• 22 Yu L Y, Zeng X C, Liu S K, Qian G S. Assay of danshensu in Lemai Keli.  Chin J Chin Mater Med. 1998;  23 729-730
• 23 Shi Z H, He H T, Zhao M P, Chang W B. Simultaneous determination of five marker constituents in traditional Chinese medicinal preparation Le-Mai granule by high performance liquid chromatography.  J Pharm Biomed Anal. 2005;  37 469-473
• 24 Chen X G, Kong L, Su X Y, Fu H J, Ni J Y, Zhao R H, Zou H F. Separation and identification of compounds in Rhizoma Chuanxiong by comprehensive two-dimensional liquid chromatography coupled to mass spectrometry.  J Chromatogr A. 2004;  1040 169-178
• 25 Chen L G, Ding L, Zhang H R, Li J, Wang Y T, Wang X P, Qu C L, Zhang H Q. Dynamic microwave-assisted extraction coupled with on-line spectrophotometric determination of safflower yellow in Flos Carthami.  Anal Chim Acta. 2006;  580 75-82