Overview of the quality standard research of traditional Chinese medicine

Abstract

Traditional Chinese medicine (TCM) has been widely used for the prevention and treatment of various diseases for a long time in China. Due to its proven efficacy, wide applications, and low side effect, TCM has increasingly attracted worldwide attention. However, one of the biggest challenges facing the clinical practice of TCM is the uncontrollable quality. In this review, the progress of the development and the current status of quality standard as well as new quality control techniques introduced in Chinese Pharmacopoeia (2010 edition), such as liquid chromatography hyphenated mass spectrometry (LC-MS), fingerprint, quantitative analysis of multi-components by single-marker (QAMS), thin layer chromatography bio-autographic assay (TLC-BAA), and DNA molecular marker technique, are briefly overviewed.

Keywords

traditional Chinese medicine / quality standard / quality control / quantitative analysis of multi-components by single-marker

References

[1] Gupta YK, Briyal S, Gulati A. Therapeutic potential of herbal drugs in cerebral ischemia. Indian J Physiol Pharmacol 2010; 54(2): 99–122

[2] Dobos GJ, Tan L, Cohen MH, 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. Complement Ther Med 2005; 13(3): 183–190

[3] Chan K, Leung KSY, Zhao SS. Harmonization of monographic standards is needed to ensure the quality of Chinese medicinal materials. Chin Med 2009; 4(1): 18

[4] Jiang Y, David B, Tu PF, Barbin Y. Recent analytical approaches in quality control of traditional Chinese medicines—a review. Anal Chim Acta 2010; 657(1): 9–18

[5] Yang M, Sun J, Lu Z, Chen G, Guan S, Liu X, Jiang B, Ye M, Guo DA. Phytochemical analysis of traditional Chinese medicine using liquid chromatography coupled with mass spectrometry. J Chromatogr A 2009; 1216(11): 2045–2062

[6] Liang XM, Jin Y, Wang YP, Jin GW, Fu Q, Xiao YS. Qualitative and quantitative analysis in quality control of traditional Chinese medicines. J Chromatogr A 2009; 1216(11): 2033–2044

[7] Xie PS, Leung AY. Understanding the traditional aspect of Chinese medicine in order to achieve meaningful quality control of Chinese materia medica. J Chromatogr A 2009; 1216(11): 1933–1940

[8] Steinmann D, Ganzera M. Recent advances on HPLC/MS in medicinal plant analysis. J Pharm Biomed Anal 2010;

[9] Li SP, Zhao J, Yang B. Strategies for quality control of Chinese medicines. J Pharm Biomed Anal 2010;

[10] Xu X, Gong Y. Quality standards of Chinese Materia Medica in developed countries and its modernization in China. Shanghai J Tradit Chin Med (Shanghai Zhong Yi Yao Za Zhi) 2006; 40(3): 50–51 (in Chinese)

[11] Cui HH, Qiu X. Development trends of modernization of TCM quality standards. Chin J Inf Tradit Chin Med (Zhongguo Zhong Yi Yao Xin Xi Za Zhi) 2007; 14(6): 6–7 (in Chinese)

[12] Hao XL, Zhang YW. Necessity of developing multi-marker quantitafication in quality standard of TCM. China Licensed Pharmacist(Zhongguo Zhi Ye Yao Shi) 2009; 6(9): 31–33 (in Chinese)

[13] Qian ZZ. Development of quality standards suitable for the characteristic of TCMs—An interpretation of Chinese Pharmacopoeia (2010 version). China J Chin Materia Medica (Zhongguo Zhong Yao Za Zhi) 2010; 35(16): 2048–2051(in Chinese)

[14] Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia, Vol I. Beijing: China Medical Science Press, 2010

[15] Chen HB, Tao Y. Development of Hong Kong Chinese Materia Medica (HKCMM) standards. J Chin Pharm Sci 2010; 19: 87–94

[16] Poole CF. Thin-layer chromatography: challenges and opportunities. J Chromatogr A 2003; 1000(1-2): 963–984

[17] Wang X, Kapoor V, Smythe GA. Extraction and chromatography-mass spectrometric analysis of the active principles from selected Chinese herbs and other medicinal plants. Am J Chin Med 2003; 31(6): 927–944

[18] Drasar P, Moravcova J. Recent advances in analysis of Chinese medical plants and traditional medicines. J Chromatogr B Analyt Technol Biomed Life Sci 2004; 812(1-2): 3–21

[19] de Rijke E, Out P, Niessen WM, Ariese F, Gooijer C, Brinkman UA. Analytical separation and detection methods for flavonoids. J Chromatogr A 2006; 1112(1-2): 31–63

[20] Oleszek W, Bialy Z. Chromatographic determination of plant saponins—an update (2002-2005). J Chromatogr A 2006; 1112(1-2): 78–91

[21] Chen G, Zhu Y, Wang Y, Xu X, Lu T. Determination of bioactive constituents in traditional Chinese medicines by CE with electrochemical detection. Curr Med Chem 2006; 13(21): 2467–2485

[22] Ganzera M. Quality control of herbal medicines by capillary electrophoresis: potential, requirements and applications. Electrophoresis 2008; 29(17): 3489–3503

[23] Adahchour M, Beens J, Brinkman UA. Recent developments in the application of comprehensive two-dimensional gas chromatography. J Chromatogr A 2008; 1186(1-2): 67–108

[24] Lao YM, Jiang JG, Yan L. Application of metabonomic analytical techniques in the modernization and toxicology research of traditional Chinese medicine. Br J Pharmacol 2009; 157(7): 1128–1141

[25] Hurtado-Fernández E, Gómez-Romero M, Carrasco-Pancorbo A, Fernández-Gutiérrez A. Application and potential of capillary electroseparation methods to determine antioxidant phenolic compounds from plant food material. J Pharm Biomed Anal 2010; 53(5): 1130–1160

[26] Yang FQ, Zhao J, Li SP. CEC of phytochemical bioactive compounds. Electrophoresis 2010; 31(1): 260–277

[27] Zhou JL, Qi LW, Li P. Herbal medicine analysis by liquid chromatography/time-of-flight mass spectrometry. J Chromatogr A 2009; 1216(44): 7582–7594

[28] Marston A. Role of advances in chromatographic techniques in phytochemistry. Phytochemistry 2007;68(22-24): 2786–2798lt;PubMed OutputMedium="All">17931672<?Pub Caret?></PubMed>

[29] Yuan HQ, Xing L. Progress on the research of quality standards. Asia-Pacific Tradit Med (Ya Tai Chuan Tong Yi Yao) 2010; 6(5): 116–117 (in Chinese)

[31] Tan Q, Wang WH, Song B, Chen LM, ZhuJJ, Wang ZM, Cui JC. Quick finding of absorption ingredients of Paeoniae Radix Alba by SEMAC.China J Chin Materia Medica (Zhongguo Zhong Yao Za Zhi) 2011; 36(6): 687–690 (in Chinese)

[31] Tan Q, Wang WH, Song B, Chen LM, ZhuJJ, Wang ZM, Cui JC. Quick finding of absorption ingredients of Paeoniae Radix Alba by SEMAC.China J Chin Materia Medica (Zhongguo Zhong Yao Za Zhi) 2011; 36(6): 687–690 (in Chinese)

[32] Wang ZM, Gao HM, Fu XT, Wang WH. Multi-components quantitation by one marker new method for quality evaluation of Chinese herbal medicine. China J Chin Materia Medica (Zhongguo Zhong Yao Za Zhi) 2006; 31(23): 1925–1928 (in Chinese)

[34] Kuang YH, Zhu JJ, Wang ZM, Zhang QW. Simultaneous quantitative analysis of five alkaloids in Rhizoma of Coptis chinensis by multi-components assay by single marker. Chin Pharm J (Zhongguo Yao Xue Za Zhi) 2009; 44(5): 390–394(in Chinese)

[34] Kuang YH, Zhu JJ, Wang ZM, Zhang QW. Simultaneous quantitative analysis of five alkaloids in Rhizoma of Coptis chinensis by multi-components assay by single marker. Chin Pharm J (Zhongguo Yao Xue Za Zhi) 2009; 44(5): 390–394(in Chinese)

[35] Homans AL, Fuchs A. Direct bioautography on thin-layer chromatograms as a method for detecting fungitoxic substances. J Chromatogr A 1970; 51(2): 327–329

[36] Qu JB, Lou HX, Fan PH. Application of TLC-bioautography to drug screening. Chin Herbal Med (Zhong Cao Yao) 2005; 36(1): 132–137 (in Chinese)

[37] Hao S X, Huang H, Liu X, Chen Y Q.Application of biological development technique in qualitative analysis for antimicrobial components of Puchiin extract. Food Ferment Ind (Shi Pin Yu Fa Jiao Gong Ye). 2004, 30(5):88–91(in Chinese)

[38] Liu X, Hao SX, Zhao LC, Huang H, Chen YQ. Study on tracking bacteriostatic components in Puchiin. Food Sci(Shi Pin Ke Xue). 2005; 26(7): 78–81 (in Chinese)

[39] He J, Zhao QM, Chen J. Study on fast detecting and tracking of antibacterial active components for endophytic fungi in Pseudolarix kaempferi Gord. With 2D-TLC bioautography. Food Sci(Shi Pin Ke Xue). 2008; 29(2): 252–256 (in Chinese)

[40] Zhao JL, Xu LJ, Huang YF, Zhou LG. Detection of antimicrobial components from extracts of the endophytic fungi associated with Paris polyphylla var. yunnanensis using TLC-bioautography-MTT assay. Nat Prod Res Dev (Tian Ran Chan Wu Yan Jiu Yu Kai Fa) 2008; 1(20): 28–32 (in Chinese)

[41] Wedge DE, Nagle DG. A new 2D-TLC bioautography method for the discovery of novel antifungal agents To control plant pathogens. J Nat Prod 2000; 63(8): 1050–1054

[42] Ramirez A, Gutiérrez R, Diaz G, González C, Pérez N, Vega S, Noa M. High-performance thin-layer chromatography-bioautography for multiple antibiotic residues in cow’s milk. J Chromatogr B Analyt Technol Biomed Life Sci 2003; 784(2): 315–322

[43] Rhee IK, van de Meent M, Ingkaninan K, Verpoorte R. Screening for acetylcholinesterase inhibitors from Amaryllidaceae using silica gel thin-layer chromatography in combination with bioactivity staining. J Chromatogr A 2001; 915(1-2): 217–223

[44] Marston A, Kissling J, Hostettmann K. A rapid TLC bioautographic method for the detection of acetylcholinesterase and butyrylcholinesterase inhibitors in plants. Phytochem Anal 2002; 13(1): 51–54

[45] Zhang X. The research on separation of natural acetylcholinesterase inhibitors with thin layer chromatography bioautography for tracking. Master thesis. Lanzhou University of Technology, 2010(in Chinese)

[46] Mimica-Dukić N, Bozin B, Soković M, Mihajlović B, Matavulj M. Antimicrobial and antioxidant activities of three Mentha species essential oils. Planta Med 2003; 69(5): 413–419

[47] Torres P, Avila JG, Romo de Vivar A, García AM, Marín JC, Aranda E, Céspedes CL. Antioxidant and insect growth regulatory activities of stilbenes and extracts from Yucca periculosa. Phytochemistry 2003; 64(2): 463–473

[48] Gu LH, Wu T, Wang ZT. TLC bioautography-guided isolation of antioxidants from fruit of Perilla frutescens var. acuta. Food Sci Technol(Shi Pin Ke Ji). 2009; 42: 131–136 (in Chinese)

[49] Zhang ZJ, Liao LP, Moore J, Wu T, Wang ZT. Antioxidant phenolic compounds from walnut kernels (Juglans regia L.). Food Chem 2009; 113(1): 160–165

[50] Tong SS, Yu JN, Xu XM, Liu XY, Jin H, Xu YP. Determination of chlorogenic acid of herba Artemisiae sopariae extracts and evaluation of its antioxidant activity using TLC-bioautography. Chin Pharm J (Zhongguo Yao Xue Za Zhi) 2009; 44(22): 1738–1741(in Chinese)

[51] Xiao GD, Li GW, Chen L, Zhang ZJ, Yin JJ, Wu T, Cheng ZH, Wei XH, Wang ZT. Isolation of antioxidants from Psoralea corylifolia fruits using high-speed counter-current chromatography guided by thin layer chromatography-antioxidant autographic assay. J Chromatogr A 2010; 1217(34): 5470–5476

[52] Sun LP, Du X, Xu X, Dong J, An ZY, Yang JL. Using TLC-bioautography to screen active compounds in Rape Bee Pollen. Food Sci(Shi Pin Ke Xue) 2010; 31(21): 69–71 (in Chinese)

[53] Gu LH, Wu T, Zhang ZJ, Chou GX, Wang ZT. Evaluation of antioxidant activity of Radix Linderae and other two Chinese drugs using TLC-bioautography. Acta Pharmaceutica Sinica (Yao Xue Xue Bao) 2006; 41(10): 956–962 (in Chinese)

[54] Xu H, Wang Z T, Hu Z B. Development and application of technology for DNA molecular identification in traditional Chinese medicine. World Sci Technol-Modernization Tradit Chin Med (Shi Jie Ke Xue Ji Shu-Zhong Yao Xian Dai Hua) 2003, 2:24–30,77 (in Chinese)

[55] Chen N, Lai XP. Identification of medicinal plant species by DNA barcode technology. J Chin Med Mater (Zhong Yao Cai) 2010; 33(4): 648–650 (in Chinese)

[56] Ren B Q, Chen Z D. DNA barcoding plant life. Chin Bull of Bot (Zhi Wu Xue Bao) 2010; 45(1):1–12 (in Chinese)

[57] Zhu Y J, Chen S L, Yao H, Tan R, Song J Y, Luo K, Lu Ji. DNA barcoding the medicinal plants of the genus Paris. Acta Pharmaceutica Sinica (Yao Xue Xue Bao) 2010; 48(3): 376–382 (in Chinese)

[58] Li N, Chen K L, Liu Z, Ye C J, Chen S L.Identification of medicinal plants from genus Sedum based on DNA barcoding. World Sci Technol–Modernization Tradit Chin Med (Shi Jie Ke Xue Ji Shu–Zhong Yao Xian Dai Hua) 2010, 3: 463–467(in Chinese)

[59] Feng CQ, Tang XJ, Huang LQ, Qian ZZ, Zhang J, Cui GH. High specific PCR identification of Bungarus multicintus and its adulterants. China J Chin Materia Medica (Zhongguo Zhong Yao Za Zhi). 2006; 31(13): 1050–1053 (in Chinese)

[60] Tang XJ, Feng CQ, Huang LQ, Qian ZZ, Cui GH, Zhang J. High specific PCR identification of Agkistrodon acutus Guenther and its adulterants. Chin J Pharm Anal(Yao Wu Fen Xi Za Zhi) 2006; 26(2): 152–155(in Chinese)

Acknowledgements

This work was supported by the Special Program for New Drug Innovation of the Ministry of Science and Technology (2009ZX09301-005 and 2009ZX09308-003).

RIGHTS & PERMISSIONS

2014 Higher Education Press and Springer-Verlag Berlin Heidelberg