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.

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.