Globalization of traditional Chinese medicines started around 1996, which was initiated by the Chinese government. However, substantial progress was only achieved in recent years including the adoption of TCM quality monographs in the western pharmacopoeias (United States Pharmacopoeia and European Pharmacopoeia) and registration in main stream drug regulatory agencies such as US Food and Drug Administration (FDA) and European Medicines Agency (EMA). So far, several TCM herbal quality monographs were adopted by the United States Pharmacopoeia including Chinese Salvia, Ganoderma lucidum and Panax notoginseng, etc. Over 45 TCM quality monographs were recorded in the European Pharmacopoeia with 20 more in progress. After the successful registration of the first TCM product named Diao Xin Xue Kang as traditional medicine via the Medicines Evaluation Board of the Netherlands, several other TCM herbal products are in the registration process in several European member states. So far, there has been still not any TCM product authorized as a drug by the FDA regardless of a few TCM products in phase III or phase II clinical trials. This review summarizes the progress made in the globalization of traditional Chinese medicines in recent years and future issues in this regard.

In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese Pharmacopoeia (ChP) 2010. Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B (Phytochemistry). Since then good progress has been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party (WP) on TCM with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities all over Europe. This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph Eur TCM WP of these monographs and will discuss these in detail. Moreover the role of Ph Eur TCM monographs in the European community is addressed.

Pharmacopoeial standards for crude drugs are established based on analysis of authenticated specimens which should be representative of the quality of material traditionally specified in systems of traditional medicine from species’ geographical origin. This reflects the ‘geo-authentic’ material that corresponds to traditional ecological and medical knowledge. In cases where specimens are obtained from cultivation outside of the species origin, this ‘authenticated’ material will not be ‘geo-authentic’. There is a growing trend for the protection of ‘geographical indication’ (GI) botanicals in the context of intellectual property rights. GI botanicals are named after a geographical area, indicating production within a particular area, quality and characteristics dependent on natural, historical and cultural factors. However, with the globalization of systems of traditional medicine such as Ayurvedic medicine and traditional Chinese medicine, Asian species are being introduced to cultivation outside of their geographical origins particularly in the EU and US. In contrast to the Chinese concept of ‘daodi’ and European concepts of ‘provenance’ or ‘terroir’ is the competing trend for ‘locally grown’ herbs, i.e. cultivated closer to where they will be used. Reasons include concerns about quality control, contamination from polluted air, soil and water in some source countries, climate change, supply chain security and traceability, costs of production and price pressure. This review looks at selected agronomic experiments aiming to discern differences between geo-authentic medicinal herbs vs. introduced crops and whether the global market cares to make a distinction or pay a price premium for articles with designations of geographical origin of specified quality. Abbreviations: AO, Appellation of Origin, GI, geographical indication; PDO, protected designation of origin; PGI, protected geographical indication; MAP, medicinal and aromatic plant; TCM, traditional Chinese medicine; TEK, traditional ecological knowledge; TSG, traditional speciality guaranteed.

Secondary plant metabolites reveal numerous biological activities making them attractive as resource for drug development of human diseases. As the majority of cancer drugs clinically established during the past half century is derived from nature, cancer researchers worldwide try to identify novel natural products as lead compounds for cancer therapy. Natural products are considered as promising cancer therapeutics, either as single agents or in combination protocols, to enhance the antitumor activity of additional therapeutic modalities. Most natural compounds exert pleotrophic effects and modulate various signal transduction pathways. A better understanding of the complex mechanisms of action of natural products is expected to open new perspectives in coming years for their use alone or in combination therapies in oncology. Two major strategies to identify novel drug candidates from nature are the bioactivity-guided fractionation of medicinal plant extracts to isolate cytotoxic chemicals and the identification of small molecules inhibiting specific targets in cancer cells. In the present review, we report on our own efforts to unravel the molecular modes of action of phytochemicals in cancer cells and focus on resveratrol, betulinic acid, artesunate, dicentrine and camptothecin derivatives.

The purpose of this study was to detect changes in urine of mice and to clarify the toxicity induced by bupleurotoxin (BETX) using liquid chromatography/quadrupole time-of-flight mass spectrometry (LC-Q-TOF-MS). A procedure for urine analysis using pattern recognition was proposed to evaluate the toxicity induced by BETX in male BALB/c mice. BETX at 2.5 mg/kg was administrated intraperitoneally (i.p.), and urine samples for the metabolomic study were collected from control and BETX experimental groups. Changes in the concentrations of some urine metabolites were detected exclusively in the experimental group. All results suggested that exposure to BETX might cause a disturbance in fatty acid metabolism and the oxidative stress system. These results may not only clarify the underlying mechanism of diverse intoxication effects of BETX but also provide the guidance in preclinical toxicity screening for new drugs.

Objective: To investigate the effect of paeonol on lipopolysaccheride (LPS)-induced rat mesenteric microcirculatory dysfunctions. Methods: Male Wistar rats were randomly distributed into 5 groups (n=6 in each): Sham group, LPS group, paeonol group, paeonol+LPS group, and LPS+paeonol group. Endotoximia model was conducted by continuous LPS infusion. Changes in mesenteric microcirculatory variables, including diameter of venule, velocity of red blood cells in venule, leukocyte adhesion, free radicals produced in venule and albumin leakage from venule, were observed through an inverted intravital microscope. Meanwhile, the expression of myeloperoxidase (MPO), CD18, intercellular adhesion molecule-1 (ICAM-1), toll-like receptor 4 (TLR4), nuclear factor-kappa B p65 subunit (NF-κB p65), activator protein-1 (AP-1), and Jun N-terminal kinase (JNK) was assessed by Western blot. Results: After infusion of LPS, the number of leukocytes adherent to venular wall, the intensity of dihydrorhodamine 123 (DHR) fluorescence in the venular walls, and albumin leakage from venules were significantly increased, whereas the red blood cell velocity in venule was decreased. All the manifestations were significantly reduced by pre-treatment and post-treatment with paeonol. Moreover, paeonol significantly attenuated the expression of MPO, CD18, ICAM-1, TLR4, NF-κB p65, AP-1 and JNK in rat mesentery after LPS. Conclusions: The results demonstrated that paeonol could protect from and ameliorate the microcirculation disturbance induced by LPS. Abbreviations: AP-1, Activator protein-1; DHR, Dihydrorhodamine-123; FITC, Fluorescein isothiocyanate; H₂O₂, Hydrogen peroxide; ICAM-1, Intercellular adhesion molecule-1; JNK, Jun N-terminal kinase; LPS, Lipopolysaccheride; MPO, Myeloperoxidase; NF-κB p65, Nuclear factor-kappa B p65 subunit; RBCs, Red blood cells; ROS, Reactive oxygen species; PBST, PBS+Tween 20; PMSF, Phenylmethylsulphonyl fluoride; PVDF, Polyvinylidene-difluoride; TLR4, Toll-like receptor 4; TNF-α, Tumor necrosis factor-alpha.

Background: Acupoint herbal patching (AHP) alone or as an adjuvant therapy with conventional treatment (CT) has been widely used for prevention and treatment of chronic obstructive pulmonary disease (COPD). However, current clinical evidence from a systematic review of RCTs is lacking. Objective: To evaluate the effectiveness and safety of AHP with or without CT for people with COPD at stable stage. Methods: We searched randomized controlled trials comparing AHP (with or without CT) with no intervention, placebo, or CT from six databases. Two authors selected studies, extracted data and evaluated risk of bias of included trials. RevMan 5.2 software was used to analysis data. Results: Twenty one RCTs (2327 participants) were included. AHP of non sanfu applied on no fixed dates with CT significantly decreased the mean frequency of acute exacerbation of COPD (times per year) (MD: -1.24; 95% CI: -2.02 to -0.46; 2 trials), and improved lung function parameters and quality of life. The AHP with CT showed no better effect in 6-minute walking distance (6MWD) that CT alone. AHP applied at sanfu (specific dates based on lunar calendar) with CT had significant effect for 6MWD (MD: 11.20; 95% CI: 0.83 to 21.56; I² = 0%; 3 trials). One trial reported skin irritation from AHP. Another trial reported two patients had eye discomfort, which was inferred as the adverse effects of seretide. Conclusion: AHP used as an adjunct to CT, appears to be more effective than CT alone in patients with stable COPD. However, further large, rigorously designed trials are warranted to confirm these potential effects.

Acupuncture, as a healing art in traditional Chinese medicine, has been widely used to treat various diseases. In the history of acupuncture anesthesia, in the past decades, mechanisms of acupuncture analgesia has been widely investigated, and in recent years, acupuncture protection on organ functions has attracted great interest. This review summarized the research progress on mechanisms of acupuncture for analgesia and its protection against organ function injury in anesthesia, and its perspective of analgesia, immunomodulation, neuroendocrine regulation and multiple organ protection. The current evidence supports that acupuncture analgesia and its organ protection in anesthesia is associated with the integration of neuroendocrine-immune networks in the level of neurotransmitters, cytokines, hormones, neuronal ensembles, lymphocytes, and endocrine cells. Although the mechanisms of acupuncture analgesia and its organ protection are still not completely understood, basic as well as clinic researches on the mechanisms and applications of acupuncture and related techniques are being carried out.