Modern European Monographs for Quality Control of Chinese Herbs

Abstract

The actual concern about the safety and efficacy of herbal drugs originating from traditional Chinese medicine (TCM) is based on observations that these medicinal plants may have a high risk potential due to insufficient definitions, problems with identity, purity and falsifications. No uniform legal status for these groups of herbal drugs currently exists in the European Union. For quality control, monographs for TCM herbs can mainly be found in the Pharmacopoeia of the Peoples Republic of China. Based on these facts the Commission of the European Pharmacopoeia decided in 2005 to establish TCM-herbal drug monographs for the most important medicinal plants imported from Far East. These new monographs had to be established and evaluated on the basis of existing monographs in the Chinese Pharmacopoeia (ChP), English edition 2005. Due to important differences in the overall features of EP and ChP, a simple adapt/adopt procedure was not feasible. Therefore, specialist groups were mandated with a corresponding working programme. Some results and actual problems related to this working programme will be presented and discussed.

Key words

TCM - traditional Chinese medicine - herbal medicinal products - quality control - pharmacopoeia - monographs

References

• 1 Dobos G J, Tan L, Cohen M H, McIntyre M, Bauer R, Li X, Bensoussan A. Are national quality standards for traditional Chinese herbal medicine sufficient? Current governmental regulations for traditional Chinese herbal medicine in certain Western countries and China as the Eastern origin country.  Compl Ther Med. 2005;  13 183-190
• 2 Vlietinck A, Pieters L, Apers S. Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European union.  Planta Med. 2009;  75 683-688
• 3 Artiges A, Spieser J M. The role and future of the European Pharmacopoeia.  Regul Affairs J. 1994;  349-351 437-440
• 4 Artiges A. The role of pharmacopoeias in international harmonisation.  J Pharm Biomed Anal. 2001;  24 769-772
• 5 European Directorate for the Quality of Medicines & Health Care .European pharmacopoeia. Available at. http://online.edqm.eu/entry.htm Accessed November 2, 2010
• 6 Xiao P-G. Recent developments on medicinal plants in China.  J Ethnopharmacol. 1983;  7 95-109
• 7 European Directorate for the Quality of Medicines & Health Care .Technical Guide for The Elaboration of Monographs. Available at. http://www.edqm.eu/medias/fichiers/Technical_Guide_for_the_Elaboration_of_Monographs_on_herbal_drugs_and_herbal_drug_preparations_2007.pdf Accessed November 2, 2010
• 8 Hsu H Y. A Study of Chinese homonymic medicinal herbs.  Oriental Healing Arts Int Bull. 1987;  12 387-408
• 9 Hu Y, Jiang Z, Leung K S, Zhao Z. Simultaneous determination of naphthoquinone derivatives in Boraginaceous herbs by high-performance liquid chromatography.  Anal Chim Acta. 2006;  577 26-31
• 10 Zhao Z Z, Hu Y, Liang Z, Yuen J P, Jiang Z, Leung K S. Authentication is fundamental for standardization of Chinese medicines.  Planta Med. 2006;  72 865-874
• 11 Wagner H, Bauer R editors.. Chinese drug monographs and analysis. Kötzting; Verlag für Ganzheitliche Medizin Dr. Erich Wühr GmbH 1996 – 2010
• 12 Chinese Pharmacopoeia Commission .TLC Atlas of Chinese Crude Drugs in Pharmacopoeia of the People's Republic of China. Beijing; People's Medical Publishing House 2009
• 13 Zhong X K, Li D C, Jiang J G. Identification and quality control of Chinese medicine based on the fingerprint techniques.  Curr Med Chem. 2009;  16 3064-3075
• 14 Yip P Y, Chau C F, Mak C Y, Kwan H S. DNA methods for identification of Chinese medicinal materials.  Chin Med. 2007;  2 9
• 15 Carles M, Cheung M K, Moganti S, Dong T T, Tsim K W, Ip N Y, Sucher N J. A DNA microarray for the authentication of toxic traditional Chinese medicinal plants.  Planta Med. 2005;  71 580-584
• 16 Techen N, Crockett S L, Khan I A, Scheffler B E. Authentication of medicinal plants using molecular biology techniques to compliment conventional methods.  Curr Med Chem. 2004;  11 1391-1401
• 17 Kabelitz L. Zur mikrobiologischen Qualität von Arznei- und Gewürzdrogen. Sind die bisherigen Anforderungen sachgerecht?.  Z Arznei Gewürzpfl. 2001;  6 174-175
• 18 Kneifel W, Czech E, Kopp B. Microbial contamination of medicinal plants – a review.  Planta Med. 2002;  68 5-15
• 19 Kabelitz L, Sievers H. Contaminants of medicinal and food herbs with a view to EU regulations.  Innovations in Food Technol. 2004;  1 25-27
• 20 Leung K S Y, Chan K, Chan C L, Lu G H. Systematic evaluation of organochlorine pesticide residues in Chinese materia medica.  Phytother Res. 2005;  19 514-518
• 21 Kabelitz L. Heavy metals in herbal drugs.  Eur J Herbal Med (Phytotherapy). 1998;  4 1-9
• 22 Chizzola R, Michitsch H, Franz C. Monitoring of metallic micronutrients and heavy metals in herbs, spices and medicinal plants from Austria.  Eur Food Res Technol. 2003;  216 407-411
• 23 Gasser U, Klier B, Kühn A V, Steinhoff B. Current findings on the heavy metal content in herbal drugs.  Pharmeuropa Sci Notes. 2009;  1 37-49
• 24 Nortier J L, Vanherweghem J L. Renal interstitial fibrosis and urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi).  Toxicology. 2002;  181–182 577-580
• 25 Ioset J R, Raoelisona G E, Hostettmann K. Detection of aristolochic acid in Chinese phytomedicines and dietary supplements used as slimming regimens.  Food Chem Toxicol. 2003;  41 29-36
• 26 Heinrich M, Chan J, Wanke S, Neinhuis C, Simmonds M S. Local uses of Aristolochia species and content of nephrotoxic aristolochic acid 1and 2-a global assessment based on bibliographic sources.  J Ethnopharmacol. 2009;  125 108-144
• 27 Fu P P, Yang Y C, Xia Q, Chou M C, Cui Y Y, Lin G. Pyrrolizidine alkaloids – tumorigenic components in Chinese herbal medicines and dietary supplements.  J Food Drug Anal. 2002;  10 198-211
• 28 Roeder E. Medicinal plants in China containing pyrrolizidine alkaloids.  Pharmazie. 2000;  55 711-726
• 29 Xue P S, Leung A Y. Understanding the traditional aspect of Chinese medicine in order to achieve meaningful quality control of Chinese materia medica.  J Chromatogr A. 2008;  1216 1913-1940
• 30 Liang Y Z, Xie P S, Chan K. Chromatographic Fingerprinting and Metabolomics for Quality Control of TCM.  Comb Chem High Throughput Screen. , advance online publication 30 September 2010
  
• 31 Liu A H, Lin Y H, Yang M, Guo H, Guan S H, Sun J H, Guo D A. Development of the fingerprints for the quality of the roots of Salvia miltiorrhiza and its related preparations by HPLC-DAD and LC-MS(n).  J Chromatogr B Analyt Technol Biomed Life Sci. 2007;  846 32-41
• 32 Cao J, Wei Y J, Qi L W, Li P, Qian Z M, Luo H W, Chen J, Zhao J. Determination of fifteen bioactive components in Radix et Rhizoma Salviae Miltiorrhizae by high-performance liquid chromatography with ultraviolet and mass spectrometric detection.  Biomed Chromatogr. 2008;  22 164-172
• 33 Liu M, Li Y, Chou G, Cheng X, Zhang M, Wang Z. Extraction and ultra-performance liquid chromatography of hydrophilic and lipophilic bioactive components in a Chinese herb Radix Salviae Miltiorrhizae.  J Chromatogr A. 2007;  1157 51-55
• 34 Csupor D, Wenzig E M, Zupkó I, Wölkart K, Hohmann J, Bauer R. Qualitative and quantitative analysis of aconitine-type and lipo-alkaloids of Aconitum carmichaeli roots.  J Chromatogr A. 2009;  1216 2079-2086
• 35 Singhuber J, Zhu M, Prinz S, Kopp B. Aconitum in traditional Chinese medicine: a valuable drug or an unpredictable risk?.  J Ethnopharmacol. 2009;  126 18-30
• 36 Lu G, Dong Z, Wang Q, Qian G, Huang W, Jiang Z, Leung K S, Zhao Z. Toxicity assessment of nine types of decoction pieces from the daughter root of Aconitum carmichaeli (Fuzi) based on the chemical analysis of their diester diterpenoid alkaloids.  Planta Med. 2010;  76 825-830
• 37 World Health Organization .WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants. Geneva; World Health Organization Geneva 2003
• 38 Gao W, Duan H, Huang L, Xiao P G, Peak K Y. Good agricultural practice (GAP) and sustainable resource utilization of Chinese materia medica.  J Plant Biotech. 2002;  4 103-107
• 39 Siow Y L, Gong Y, Au-Yeung K K W, Woo C W H, Choy P C. Emerging issues in traditional Chinese medicine.  Can J Physiol Pharmacol. 2005;  83 321-334
• 40 Chan K, Leung K S, Zhao S S. Harmonization of monographic standards is needed to ensure the quality of Chinese medicinal materials.  Chin Med. 2009;  4 18