A New Concept on Quality Marker for Quality Assessment and Process Control of Chinese Medicines

Chinese medicine （CM） is the most typical conventional therapy compared with any other traditional or alternative medicine systems. The active components of CMs are either primary or secondary metabolites generated by metabolic and biosynthetic enzymes in plants, protecting the plants from environmental stress. The characteristics of these metabolites are diverse, complicated and unique. In this paper, current approaches for quality assessment were extensively reviewed, a new concept of quality marker （Q-marker） was then proposed for CM quality assessment. Additionally, definition of the Q-marker, as well as the relevant methods, were discussed, on the basis of the biosynthetic pathways of secondary metabolites and source of biological active components. Study design of Q-marker is complex system for quality assessment and production process control of CM products with transitivity and traceability. Therefore, the system with characteristics of transmission and traceability is expected to be established for regulation of quality. Upon the concept which the transitivity and traceability in the quality assessment and production process control covered the entire process, such as raw materials, decoction slices, processing, extraction and production can be further enhanced. The transitivity and traceability will inevitably require close attention to ＂who, what, where, when, and why＂ details at each stage of Q-markers of CM production form raw materials to patent product. The establishing quality standards are enablers of many and various transitivity and traceability solutions, not a solution in them. It means that the transitivity and traceability system is readily link between products and across borders in quality. According to the thinking mode and methods of investigation on quality assessment of CM product, we focus on the entire process, in terms of safety and effectiveness and quality control. The standard preparation of CM or CM decoction is not only the basis for study of Q-marker, but also the basis for transmission and traceability of the quality of CM product.

Approaches to establish Q-markers for the quality standards of traditional Chinese medicines

Traditional Chinese medicine(TCM) has played a pivotal role in maintaining the health of Chinese people and is now gaining increasing acceptance around the global scope. However, TCM is confronting more and more concerns with respect to its quality. The intrinsic "multicomponent and multitarget" feature of TCM necessitates the establishment of a unique quality and bioactivity evaluation system, which is different from that of the Western medicine. However, TCM is investigated essentially as"herbal medicine" or "natural product", and the pharmacopoeia quality monographs are actually chemicalmarkers-based, which can ensure the consistency only in the assigned chemical markers, but, to some extent, have deviated from the basic TCM theory. A concept of "quality marker"(Q-marker), following the "property-effect-component" theory, is proposed. The establishment of Q-marker integrates multidisciplinary technologies like natural products chemistry, analytical chemistry, bionics, chemometrics,pharmacology, systems biology, and pharmacodynamics, etc. Q-marker-based fingerprint and multicomponent determination conduce to the construction of more scientific quality control system of TCM.This review delineates the background, definition, and properties of Q-marker, and the associated technologies applied for its establishment. Strategies and approaches for establishing Q-marker-based TCM quality control system are presented and highlighted with a few TCM examples.

Research and Application of Adlay in Medicinal Field

The traditional Chinese medicine（TCM） adlay has been used as a dietary supplement to promote health and treat various ailments for thousands of years.The effective and safe ingredients of TCM could be used as sources for developing new drugs.This paper reviews the main research and application of adlay seed in medicinal field in the following aspects：botanical resource,ethnopharmacological function,chemical constituents,pharmacology and pharmacokinetics,safety evaluation and toxicity,and clinical application.We hope that the review could help researchers mine the scientific values of adlay seed,innovative drug design,provide the guidance for the application in clinical therapy,and enhance the academic level and clinical efficacy of adlay seed.

Discovery of the radio-protecting effect of Ecliptae Herba,its constituents and targeting p53-mediated apoptosis in vitro and in vivo

Radiation protection drugs are often accompanied by toxicity,even amifostine,which has been the dominant radio-protecting drug for nearly 30 years.Furthermore,there is no therapeutic drug for radiation-induced intestinal injury(RⅢ).This paper intends to find a safe and effective radioprotecting ingredient from natural sources.The radio-protecting effect of Ecliptae Herba(EHE) was discovered preliminarily by antioxidant experiments and the mouse survival rate after137Cs irradiation.EHE components and blood substances in vivo were identified through UPLC-Q-TOF.The correlation network of “natural components in EHE-constituents migrating to blood-targets-pathways” was established to predict the active components and pathways.The binding force between potential active components and targets was studied by molecular docking,and the mechanism was further analyzed by Western blotting,cellular thermal shift assay(CETSA),and Ch IP.Additionally,the expression levels of Lgr5,Axin2,Ki67,lysozyme,caspase-3,caspase-8,8-OHd G,and p53 in the small intestine of mice were detected.It was found for the first time that EHE is active in radiation protection and that luteolin is the material basis of this protection.Luteolin is a promising candidate for RⅢ.Luteolin can inhibit the p53 signaling pathway and regulate the BAX/BCL2 ratio in the process of apoptosis.Luteolin could also regulate the expression of multitarget proteins related to the same cell cycle.

Author correction to‘Discovery of the radioprotecting effect of ecliptae herba,its constituents and targeting p53-mediated apoptosis in vitro and in vivo’[Acta Pharm Sin B 13(2023)1216-1230]

The authors regret that there is an error in the article Fig.4B due to the mistake of copying and pasting in the process of assembling figures and negligence in the proofreading.Although it does not affect the conclusion,it is an obvious error.The authors have now modified as below.The authors apologize for any inconvenience caused to the journal and readers.

Medicinal Plant of Bletilla striata: A Review of its Chemical Constituents, Pharmacological Activities, and Quality Control

Bletilla striata belongs to the family Orchidaceae,and it is mainly distributed in East Asia.The tubers of B.striata have been utilized in Traditional Chinese Medicine for various ailments,such as hematemesis,tuberculosis,malignant ulcers,hemorrhoids,traumatic bleeding,and chapped skin.Phytochemical investigation on B.striata has resulted in the identification of 192 monomeric compounds,including bibenzyls,phenanthrene derivatives,triterpenoids and its saponins,steroids and its saponins,malic acid derivatives,and anthocyanins.Moreover,B.striata polysaccharide is another typical chemical constituent of this plant.Pharmacology studies have shown that the plant possesses wound healing,antimicrobial,anticancer,antioxidative,and antiviral activities.This review aims to provide the latest and comprehensive information on chemical constituents,pharmacological activities,and quality control of B.striata and to identify future research needs.