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.

Prediction of quality markers of traditional Chinese medicines based on network pharmacology

Network pharmacology is a powerful tool to reflect the pharmacologically active effects,mechanism of action and toxic activity of traditional Chinese medicines(TCMs).The ingredients of TCMs,associated with quality control of TCM products,are those fundamental chemicals that exhibit biological activities.A great amount of effort has been made by scientists in that field in order to improve the quality of TCMs,though the approaches to determine their quality and the TCM theory and compatibility rules remain ambiguous.Now some methods and technologies must be applied to predict and explore the quality marker(Q-marker)for quality control,as well as to clarify the factors affecting the quality of TCM,which may give new insight into rational ground of establishment of appropriate quality control and assessment system.In this review paper,authors focus on the prediction of quality markers of TCMs by network pharmacology based on three aspects:(1)from network medicine to network pharmacology,(2)complex network system of traditional Chinese medicine,and(3)predicting TCM quality markers based on network pharmacology.Authors proposed the research pattern on network pharmacology based on biological and medical networks,and further TCM network pharmacology based on substantial basis of TCM formulae,and the idea of"effect-ingredient-target-fingerprint"to predict and recognize the TCM Qmarker was the ultimate goal.In addition,authors yet noted how to make full use of the advantages of network toxicology to provide new ideas for the toxicity study of complex TCM systems and the prediction of TCM toxicity markers.

Effects of total iridoid glycosides of Picrorhiza scrophulariiflora against non-alcoholic steatohepatitis rats induced by high-fat and high-sugar diet through regulation of lipid metabolism

Objective:To investigate the therapeutic effect of total iridoid glycosides of Picrorhiza scrophulariiflora(TIGP)on non-alcoholic steatohepatitis(NASH).Methods:SD rats were fed with high-fat and high-sugar diet for 8 weeks to establish NASH.TIGP were given orally at doses of 20,40 and 80 mg/kg/d for 4 weeks.Triglycerides assay(TG),total cholesterol(TC),low density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C),aspartate aminotransferase(AST),alanine aminotransferase(ALT),fasting plasma glucose(FPG),fasting insulin(FINS),tumor necrosis factor-α(TNF-α),interleukin-6(IL-6),chemokine-1(MCP-1),leptin(LEP)in serum were tested.TG,TC,superoxide dismutase(SOD),malondialdehyde(MDA),and free fatty acid(FFA)in liver tissue were determined by colorimetric methods.Steatosis of hepatocytes and inflammation was performed by pathological examination.Results:The results showed that TIGP significantly decreased TC,TG and FFA in liver tissue,increased SOD activity,decreased MDA content,decreased serum levels of TG,TC,HDL-C/LDL-C,ALT,AST,GLU,HOMA-IR,TNF-αand LEP,and in addition,improved steatosis of liver cells compared to NASH.Conclusion:TIGP had anti-fatty liver effect against NASH rats induced by high-fat and high-sugar diet.Its mechanism was related to the regulation of lipid metabolism and reduction of insulin resistance,through inhibition of oxidative stress and inflammation.

Randomized Clinical Trials of Traditional Chinese Medicines for Treating Ulcerative Colitis:A Scoping Review

Objective:Traditional Chinese medicines(TCMs)are efficacious against ulcerative colitis(UC).In recent years,the number of randomized clinical trials(RCTs)of TCM has increased.Thus,it is very important to summarize the basic characteristics,quality,and types of TCM interventions in published RCTs.This scoping review was performed to systematically identify and describe the current situations about RCTs of TCMs for treating UC.Hope to express the focus and specifics of nowadays research in TCM interventions in RCTs and evaluate their common disadvantages exposed to help advance in TCM researching.Materials and Methods:A scoping review was conducted according to the PRISMA extension for scoping reviews.We searched two English databases and four Chinese databases from the date of establishment of each database to January 2020.Data from RCTs focusing on any TCM treatment for patients with UC were extracted and evaluated.Selection and characterization were performed by two independent reviewers using predefined forms.All discrepancies were resolved by consensus discussion with a third reviewer.Microsoft Excel 2010 was used to extract the following data from the included studies:(1)basic information of the included studies including research ID,article title,publication language,journal,year of publication,and funding information;(2)patient information including gender,age,disease course,disease stage,severity,sample size;and(3)information on intervention measures,types of intervention measures,drug dosage forms,and treatment courses.Results:The search identified 2225 RCTs published between1987 and 2020.These studies covered 36 provinces in China.The time frame of the RCTs was<28 days in approximately one-third of the RCTs(647,29.08%).Only one RCT was published in English.Nearly three-quarters of RCTs(1665,74.83%)did not report the severity of the disease.Three types of interventions were included in the RCTs:pharmacotherapy(2028,91.15%),nonpharmacotherapy(57,2.56%),and a combination of the two(140,6.29%).The administration modes of the intervention groups were evaluated.Drug therapy involved 12types of TCM dosage forms,which were decoctions,troches,powders,capsules,granules,pills,suppositories,ointments,injections,gels,oral liquids,and substitute tea according to the frequency of use.Nondrug intervention measures involved 10 treatment options,namely,acupuncture,moxibustion,hemospasia,auricular point,acupoint catgut embedding,acupoint injection,scrapping,tuina,acupoint application,and five-tone therapy according to the frequency of use.Most studies included in this review were low in quality.This underscores the need for improvement in the quality of trial methodology in TCM RCTs.

Chemical constituents and pharmacological effects of genus Engelhardia

Engelhardia Leschen. ex Blume （Juglandaceae） is native to southern and southeastern Asia and used to be traditional medicines and health tea. Hitherto, a large amount of chemical constituents had been iso- lated from genus Engelhardia and more pharmacological effects were found due to the presence of the second metabolites. There have been few comprehensive reports about Engelhardia plants especially the chemical constituents by now. The traditional usage of Engelhardia plants were for treating cold fever, detoxication, rheumatism, diarrhea, obesity, gastrointestinal problem and so on. While the modern pharmacological activities showed antioxidant activity, anti-ischemialreperfusion injury, anticancer activity, anti-inflammatory activity, immunosuppression activity, antidiabetic activity, antitubercular activity and so on. In this review, constituents of this genus would be introduced and classified by structures, the pharmacological effects of which would be described as well.