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Review
. 2021 Apr;11(2):155-162.
doi: 10.1016/j.jpha.2020.11.008. Epub 2020 Nov 28.

Development of chromatographic technologies for the quality control of Traditional Chinese Medicine in the Chinese Pharmacopoeia

Ming-Rui Shen  1 , Yi He  1 , Shang-Mei Shi  1
Affiliations
Review

Development of chromatographic technologies for the quality control of Traditional Chinese Medicine in the Chinese Pharmacopoeia

Ming-Rui Shen et al. J Pharm Anal. 2021 Apr.

Abstract

As an important branch of medicine, Traditional Chinese Medicine (TCM) has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia. The Chinese Pharmacopoeia (ChP) is a drug code formulated by the Chinese government, and it includes a special volume for the monographs of TCM, which plays an important role in ensuring the quality of drugs. The use of quality control technology has always been a complex and important factor in TCM. Owing to the chemical diversity of TCM, chromatography technology has been proven to be a comprehensive strategy for the assessment of the overall quality of TCM and has become the main analytical method in the ChP. This article provides an overview of the classical and modern chromatographic technologies applied in the ChP, and summarizes the advantages and disadvantages of each technique in the TCM monographs. In 2020, the new edition of the ChP (the 2020 edition) has been implemented at the end of 2020. This paper also contains a brief introduction about the application of chromatographic technologies in the new edition of the ChP.

Keywords: Chinese pharmacopoeia; Chromatographic technology; Quality control; Traditional Chinese medicine.

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Conflict of interest statement

The authors declare that there are no conflicts of interest.

Figures

Image 1
Graphical abstract
Fig. 1
Fig. 1
(A) The number of chromatographic methods applied in each edition of the ChP. (B) The percentage of chromatographic methods applied in each edition of the ChP (Refs. [[4], [5], [6], [7], [8], [9], [10], [11]]).
Fig. 2
Fig. 2
TLC identifications of Dalbergiae Odoriferae Lignum, examined under (A) visible light and (B) ultraviolet light at 365 nm. Track S, Dalbergiae Odoriferae Lignum reference drug (S); tracks 1–8, samples of Dalbergiae Odoriferae Lignum collected from different regions in China. The drafter of this figure, Shanghai R&D Center for Standardization of Traditional Chinese Medicines (Ref. [13]).
Fig. 3
Fig. 3
The fingerprint of Qingkailing Injection. 1, unknown (from Isatidis Radix); 2, unknown (from Margaritifera Concha); 3, uridine (from Isatidis Radix); 4, unknown; 5, adenosine (from Isatidis Radix); 6, guanosine (from Isatidis Radix); 7, unknown (from Isatidis Radix); 8, tryptophan (from Bubali Cornu); 9, chlorogenic acid (from Lonicerae Japonicae Flos); 10 (S), geniposide (from Gardeniae Fructus). The drafter of this figure, Beijing Institute for Drug Control (Ref. [4]).
Fig. 4
Fig. 4
The characteristic chromatogram of Notopterygii Rhizoma et Radix. 1, notopterol; 2, phenethylferulate; 3, isoimperatorin; 4, falcarindiol. The drafter of this figure, School of Pharmaceutical Sciences, Peking University (Ref. [4]).
See this image and copyright information in PMC

References

    1. Liang Y.Z., Xie P.S., Chan K. Chromatographic fingerprinting and metabolomics for quality control of TCM. Comb. Chem. High Throughput Screen. 2010;13:943–953. - PubMed
    1. Li S.P., Zhao J., Qian Z.M. Advanced development of chromatography in screening and identification of effective compounds in Chinese materia medica. Chem. SciChina. 2010;40:651–667.
    1. Kunle O.F., Egharevba H.O., Ahmadu P.O. Standardization of herbal medicines - a review. Int. J. Biodivers. Conserv. 2012;4:101–112.
    1. Chinese Pharmacopoeia Commission . China Medical Science Press; Beijing, China: 2015. Pharmacopoeia of the People’s Republic of China.
    1. Chinese Pharmacopoeia Commission . People’s Medical Publishing House; Beijing, China: 1977. Pharmacopoeia of the People’s Republic of China.