Market access for Chinese herbal medicinal products in Europe-A ten-year review of relevant products, policies, and challenges.

Background: With increased consumer demand in Europe for natural and efficacious health products, the use of herbal products in the market is rising. Products of Chinese herbal medicine (CHM) could greatly expand European consumer options; however, only seven herbal medicinal products (HMPs) based on CHM formulae have been registered in the European Union (EU) since 2012.

Purpose: This study reviews the ten-year registration status of HMPs based on CHM formulae in Europe and identifies major challenges and possible solutions for pharmaceutical companies seeking market access for new HMPs.

Improved route to a diphenoxide-based precursor for chemical vapour deposition of parylene AF-4.

In this work, we present the synthesis of an alternative precursor for chemical vapour deposition of parylene AF-4 to the widely used standard, octafluoro[2.2]paracyclophane. The standard precursor suffers from uncertainties in its supply chain and its synthesis is of low yield.

MRI/TRUS fusion vs. systematic biopsy: intra-patient comparison of diagnostic accuracy for prostate cancer using PI-RADS v2.

Objective: To evaluate the efficacy of multiparametric magnetic resonance/transrectal ultrasound fusion (MRI/TRUS fusion) biopsy versus systematic biopsy and its association with PI-RADS v2 categories in patients with suspected prostate cancer.

Materials And Methods: 122 patients undergoing both MRI/TRUS fusion and systematic biopsy, with suspicion of prostate cancer, with suspicious findings on MRI based on PI-RADS v2, were included between April 2016 and March 2017. Comparison of tumor detection rates using each technique and combined techniques was performed for all lesions as well as those that are traditionally difficult to access (i.

Bi-layer sandwich film for antibacterial catheters.

Approximately one quarter of all nosocomial infections can be attributed to the urinary tract. The infections are supposed to be mainly caused by implantations of urethral catheters and stents. A new catheter design is introduced with the aim to lower the high number of nosocomial urethral infections.

Efficacy of silver/hydrophilic poly(p-xylylene) on preventing bacterial growth and biofilm formation in urinary catheters.

Catheter associated urinary tract infections (CAUTI), caused by several strains of bacteria, are a common complication for catheterized patients. This may eventually lead to a blockage of the catheter due to the formation of a crystalline or amorphous biofilm. Inhibiting bacteria should result in a longer application time free of complaints.

Remission spectrometry for blood vessel detection during stereotactic biopsy of brain tumors.

Stereotactic biopsy is used to enable diagnostic confirmation of brain tumors and treatment planning. Despite being a well-established technique, it is related to significant morbidity and mortality rates mostly caused by hemorrhages due to blood vessel ruptures. This paper presents a method of vessel detection during stereotactic biopsy that can be easily implemented by integrating two side-view fibers into a conventional side-cutting biopsy needle.

Silver ions eluted from partially protected silver nanoparticles.

The most prominent character of a new type of antibacterial urological catheters is the zebra-stripe pattern of a silver film, which is plated electroless on their interior wall and capped by a very thin semipermeable layer of parylene. This design effectively controls the release rate of Ag(+) ions in artificial urine, which has been measured as function of time with optical emission spectroscopy. By evaluating the minimum inhibitory concentration against certain strains of bacteria with solutions of AgNO3 of known concentration with the method of optical density and applying this analysis to the silver-eluting catheters, it was shown that this moderation prolongs the period of their application significantly.

Microbiological investigation of an antibacterial sandwich layer system.

To allow medical application of an artificial bladder made of biocompatible polyurethane, a long-term stable antibacterial coating is required. Alone, the artificial bladder exhibits no defense against microorganisms. Silver coating provides long-term antibacterial protection by the continuous release of silver ions into aqueous solutions.

Modern European monographs for quality control of Chinese herbs.

The actual concern about the safety and efficacy of herbal drugs originating from traditional Chinese medicine (TCM) is based on observations that these medicinal plants may have a high risk potential due to insufficient definitions, problems with identity, purity and falsifications. No uniform legal status for these groups of herbal drugs currently exists in the European Union. For quality control, monographs for TCM herbs can mainly be found in the Pharmacopoeia of the Peoples Republic of China.

Aerobic exercise with relaxation: influence on pain and psychological well-being in female migraine patients.

Objective: The objective of this pilot study was to address the influence of an aerobic exercise program combined with relaxation on pain and psychological variables in migraine patients.

Design: Controlled, randomised design with half of the group receiving an intervention (aerobic exercise group) in addition to standard medical care received by all patients. SETTING/PATIENTS/OUTCOME MEASUREMENT: Thirty female migraine outpatients completed a range of psychological questionnaires measuring sensational and affective dimensions of pain, body image, depression, and quality of life.

Case report: severe heat stroke with multiple organ dysfunction - a novel intravascular treatment approach.

Introduction: We report the case of a patient who developed a severe post-exertional heat stroke with consecutive multiple organ dysfunction resistant to conventional antipyretic treatment, necessitating the use of a novel endovascular device to combat hyperthermia and maintain normothermia.

Methods: A 38-year-old male suffering from severe heat stroke with predominant signs and symptoms of encephalopathy requiring acute admission to an intensive care unit, was admitted to a ten-bed neurological intensive care unit of a tertiary care hospital. The patient developed consecutive multiple organ dysfunction with rhabdomyolysis, and hepatic and respiratory failure.

Essential Oil of Betula pendula Roth. Buds.

The essential oil of Betula pendula Roth. buds was obtained using both hydrodistillation and microdistillation techniques and their chemical compositions were analyzed using both gas chromatography (GC) and gas chromatography-mass spectrometry (GC-MS). Overall, more than 50 compounds were identified representing 80% and 92% for hydrodistillation and microdistillation, respectively.

Beta-1,3 glucan sulfate, but not beta-1,3 glucan, induces the salicylic acid signaling pathway in tobacco and Arabidopsis.

Sulfate substituents naturally occurring in biomolecules, such as oligosaccharides and polysaccharides, can play a critical role in major physiological functions in plants and animals. We show that laminarin, a beta-1,3 glucan with elicitor activity in tobacco (Nicotiana tabacum), becomes, after chemical sulfation, an inducer of the salicylic acid (SA) signaling pathway in tobacco and Arabidopsis thaliana. In tobacco cell suspensions, the oxidative burst induced by the laminarin sulfate PS3 was Ca2+ dependent but partially kinase independent, whereas laminarin triggered a strickly kinase-dependent oxidative burst.

Stability control of senna leaves and senna extracts.

Powdered senna leaves and a commercial methanolic senna leaf extract were investigated for apparent degradation pathways of known constituents. Different defined storage conditions were chosen according to the guidelines of the international conference on harmonization. Analytical fingerprinting was carried out by HPLC with photodiode array detection.

Investigation of the Origanum onites L. essential oil using the chorioallantoic membrane (CAM) assay.

The in vivo test on the chorioallantoic membrane of the fertilized hen's egg (CAM assay) is a current method to determine antiangiogenic, antiinflammatory activity and toxic effects of individual compounds or complex plant extracts. The method is used for testing natural compounds in small amounts for revealing various modes of action and the complex mechanisms related to angiogenesis and inflammation. Furthermore, possible side effects such as membrane irritation, toxic, and anticoagulant properties of the investigated material in question can be detected.

Chemical composition of the essential oil of Phlomis linearis Boiss. & Bal., and biological effects on the CAM-assay: a safety evaluation.

Phlomis linearis Boiss. & Bal. of the Lamiaceae family growing in central, east and southeast Anatolia is an endemic species for Turkey.

Inhibition of PMN-elastase activity by semisynthetic glucan sulfates.

Proteolysis of connective tissue by enzymes such as PMN-elastase (PMNE) is a crucial step during inflammation and metastasis. Semisynthetic sulfated carbohydrates (SC) were shown to exhibit potent antiinflammatory and antimetastatic activity in vivo. The aim of the present study was to examine whether interferences with PMN-elastase may contribute to these effects.

LaPSvS1, a (1-->3)-beta-galactan sulfate and its effect on angiogenesis in vivo and in vitro.

LaPSvS1, a highly sulfated branched (1-->3)-beta-galactan was prepared from the arabino-galactan from Larix decidua Miller by partial hydrolysis and subsequent sulfation with SO(3)-pyridine in DMF. The molecular weight was analyzed by GPC and the sulfate content was determined by ion chromatography. LaPSvS1 exhibited good antiangiogenic and antiinflammatory effects in two different modifications of the known CAM-assay.

Temporal and spatial profile of Bid cleavage after experimental traumatic brain injury.

Apoptosis plays an essential role in the cascade of CNS cell degeneration after traumatic brain injury. However, the underlying mechanisms are poorly understood. The authors examined the temporal profile and cell subtype distribution of the proapoptotic protein Bid from 6 hours to 7 days after cortical impact injury in the rat.