Max Zeller Sohne AG
Max Zeller Sohne AG
Bauer S.,Max Zeller Sohne AG |
Herde A.,SALUS Haus GmbH and Co. KG |
Schlegel P.,Dr. Willmar Schwabe GmbH and Co. KG |
Daniel M.,Finzelberg GmbH and Co. KG |
And 3 more authors.
Pharmazeutische Industrie | Year: 2017
For the production of herbal extracts, organic solvents (e. g. ethanol) are recovered/recycled in many cases during the production process. Such a procedure performed for environmental as well as safety reasons is generally accepted. With regard to the further use of recovered solvents, an individual risk-based decision has to be made as to whether the solvent can be used as such or if further recycling process steps (e. g. rectification) have to be performed. In order to meet appropriate quality criteria of recovered/recycled solvents and of the extracts resulting from their use, testing of the solvent is required prior to further production. After an individual, product-related risk assessment, the manufacturer decides which parameters are obligatory for the respective recovered or recycled solvent. © ECV • Editio Cantor Verlag, Aulendorf (Germany).
Disch L.,Max Zeller Sohne AG |
Disch L.,University of Heidelberg |
Drewe J.,Max Zeller Sohne AG |
Fricker G.,University of Heidelberg
Dissolution Technologies | Year: 2017
Herbal medicines are the oldest method for treating diseases and at the same time still the most commonly used worldwide. Although people in developing countries depend on traditional herbal medicines, herbal products also play an important role in the healthcare systems of industrialized countries due to ongoing health trends for substituting natural products for potentially harmful chemicals. The regulatory standards of various authorities for herbal medicines are not harmonized in regional classification and quality requirements. It is particularly difficult to oversee authority requirements for dissolution testing of herbal medicines due to widely varying regulations. The aim of this article is to give a short overview of regulatory classification and dissolution standards of herbal medicinal products with regard to regional differences in Europe, the United States, and Asia. Furthermore, challenges in dissolution method development for herbal medicines are discussed. Because the ingredients of herbal medicinal products often cover a mixture of multiple herbal constituents, dissolution method development is much more complex than for defined single constituents. © 2017, Dissolution Technologies Inc. All rights reserved.
Brattstrom A.,Max Zeller Sohne AG |
Schapowal A.,Praxis Inc. |
Maillet I.,French National Center for Scientific Research |
Schnyder B.,French National Center for Scientific Research |
And 3 more authors.
Phytotherapy Research | Year: 2010
Background: The herbal Petasites hybridus (butterbur) extract (Ze 339, PET) is known to have leukotriene inhibiting properties, and therefore might inhibit allergic diseases. Methods: The effect of PET was investigated in ovalbumin (OVA) immunized BALB/c mice given intranasally together with antigen challenge in the murine model of allergic airway disease (asthma) with the analysis of the infl ammatory and immune parameters in the lung. Results: PET given with the antigen challenge inhibited the allergic response. PET inhibited airway hyperresponsiveness (AHR) and eosinophil recruitment into the bronchoalveolar lavage (BAL) fl uid upon allergen challenge, but had no effect in the saline control mice. Eosinophil recruitment was further assessed in the lung by eosinophil peroxidase (EPO) activity at a concentration of 100 mg PET. Microscopic investigations revealed less infl ammation, eosinophil recruitment and mucus hyperproduction in the lung with 100 μg PET. Diminution of AHR and infl ammation was associated with reduced IL-4, IL-5 and RANTES production in the BAL fl uid with 30 μg PET, while OVA specifi c IgE and eotaxin serum levels remained unchanged. Conclusion: PET, which has been reported to inhibit leukotriene activity, reduced allergic airway infl ammation and AHR by inhibiting the production of the Th2 cytokines IL-4 and IL-5, and RANTES. Copyright © 2009 John Wiley & Sons, Ltd.
Simon D.,University of Bern |
Eng P.A.,Childrens Hospitals Aarau |
Eng P.A.,Childrens Hospitals Lucerne |
Borelli S.,Triemli Hospital |
And 9 more authors.
Advances in Therapy | Year: 2014
Introduction: Atopic dermatitis (AD) has been related to a deficiency of delta-6-desaturase, an enzyme responsible for the conversion of linoleic acid to gamma-linolenic acid (GLA). Evening primrose oil (EPO) contains high amounts of GLA. Therefore, this study investigated whether EPO supplementation results in an increase in plasma GLA and its metabolite dihomo-gamma-linolenic acid (DGLA) correlating with clinical improvement of AD, assessed by the SCORing Atopic Dermatitis (SCORAD) index. Methods: The open study included 21 patients with AD. EPO (4-6 g) was administered daily for 12 weeks. Before treatment, and 4 and 12 weeks after initiation of EPO supplementation, objective SCORAD was assessed and plasma concentrations of GLA and DGLA were determined by gas chromatography. Results: A significant increase in plasma GLA and DGLA levels and a decrease in the objective SCORAD were observed 4 and 12 weeks after initiation of EPO treatment. In the per-protocol population (n = 14), a significant inverse correlation between the changes in plasma GLA levels and SCORAD was found (P = 0.008). Conclusion : The clinical disease activity under EPO treatment correlates with the individual increase in plasma GLA levels. Thus, the results of this pilot study indicate that an increase in plasma GLA might be used as predictive parameter for responsiveness of AD to EPO therapy. © The Author(s) 2014.
Dumitru A.F.,Imperial College London |
Shamji M.,Imperial College London |
Wagenmann M.,Heinrich Heine University Düsseldorf |
Hindersin S.,Heinrich Heine University Düsseldorf |
And 12 more authors.
Journal of Allergy and Clinical Immunology | Year: 2011
Background: Allergic rhinitis symptoms of itching, sneezing, rhinorrhea, and nasal obstruction significantly decrease patients' quality of life. Compared with histamine and leukotriene receptor antagonists, the petasol butenoate complex Ze 339 displays pharmacologically distinct properties. In vitro it inhibits the biosynthesis of leukotrienes and mediator release from activated eosinophils. Objective: This study aimed to assess the efficacy and mode of action of Ze 339, desloratadine, and placebo on allergic rhinitis symptoms, nasal airflow, and local mediator levels after unilateral nasal allergen provocation. Methods: In this double-blind, randomized, crossover study 18 subjects with allergic rhinitis to grass pollen received Ze 339, desloratadine, and placebo for 5 days before nasal allergen challenge with grass pollen extract. Rhinomanometry, symptom assessment, and local inflammatory mediator measurement were performed during the 24 hours after allergen challenge. Results: With Ze 339, the patient's time to recovery (5.4 ± 1.6 hours) from nasal obstruction after allergen challenge (time for return to 90% of baseline value ± SEM) was significantly shorter than with placebo (9.1 ± 2.3 hours, P = .035) and desloratadine (10.7 ± 2.5 hours, P = .022). Likewise, Ze 339's standardized symptom assessment for nasal obstruction (3.2 ± 1.3 hours) showed significantly faster relief (time for return to baseline value ± SEM compared with placebo, 8.3 ± 2.4 hours; P = .027) and desloratadine (4.5 ± 1.2 hours, P = .030). One interesting finding was that Ze 339 significantly reduced IL-8 and leukotriene B4 levels in nasal secretions before challenge. Conclusion: When compared with desloratadine and placebo, Ze 339 shows better efficacy in relieving nasal obstruction symptoms and inhibiting critical components of the chemokine network and as such represents a novel symptomatic and possible prophylactic treatment for allergic rhinitis. © 2011 American Academy of Allergy, Asthma & Immunology.
Schellenberg R.,Institute for Health Care and Science |
Saller R.,University of Zürich |
Hess L.,Brunner and Hess |
Melzer J.,University of Zürich |
And 3 more authors.
Evidence-based Complementary and Alternative Medicine | Year: 2012
Extracts from Cimicifuga racemosa (CR, synonym Actaea racemosa) have shown efficacy in trials in women with menopausal symptoms. Yet, dose dependency remains unclear. Therefore, 180 female outpatients with climacteric complaints were treated for 12 weeks in a randomized, double-blind, placebo-controlled, 3-armed trial (CR extract Ze 450 in 6.5 mg or 13.0 mg, or placebo). Primary outcome was the difference in menopausal symptoms (vasomotor, psychological, and somatic), assessed by the Kupperman Menopausal Index between baseline and week 12. Secondary efficacy variables were patients' self-assessments of general quality of life (QoL), responder rates, and safety. Compared to placebo, patients receiving Ze 450 showed a significant reduction in the severity of menopausal symptoms in a dose-dependent manner from baseline to endpoint (mean absolute differences 17.0 (95% CI 14.65-19.35) score points, P < 0.0001 for 13.0 mg; mean absolute differences 8.47 (95% CI 5.55-11.39) score points, P = 0.0003 for 6.5 mg). QoL and responder rates corresponded with the main endpoint. Changes in menopausal symptoms and QoL were inversely correlated. Reported adverse events and clinical laboratory testing did not raise safety concerns. The CR extract Ze 450 is an effective and well-tolerated nonhormonal alternative to hormone treatment for symptom relief in menopausal women. © 2012 Ruediger Schellenberg et al.
PubMed | Helmholtz Center Munich, TU Munich and Max Zeller Sohne AG
Type: | Journal: BioFactors (Oxford, England) | Year: 2017
Ze339, an herbal extract from Petasites hybridus leaves is effective in treatment of allergic rhinitis by inhibition of a local production of IL-8 and eicosanoid LTB
Drewe J.,Max Zeller Sohne AG |
Zimmermann C.,Max Zeller Sohne AG |
Zahner C.,Max Zeller Sohne AG
Phytomedicine | Year: 2013
Background: Root extracts of Cimicifuga racemosa (L.) Nutt. have been successfully used in the treatment of climacteric complaints. Method: In this observational study, Cimicifuga racemosa (CR) extract Ze 450 was studied in 442 unselected ambulatory female outpatients with menopausal complaints under daily practice conditions. Physicians were suggested to treat patients for the first 3 months with 13 mg/d CR (high dose, HD) and to continue over additional 6 months either with this treatment or to switch to 6.5 mg/d CR (low dose, LD). The choice of treatment and its dose, however, was fully at the discretion of the physician. Results: After 3-months treatment with HD, symptom severity (Kupperman Menopause Index, KMI) decreased significantly (p < 0.001) from baseline values. Continuation of treatment with HD or LD decreased total KMI and its sub-item scores further (HD, LD: p < 0.001). However, more patients (84.9%) responded to HD than to LD (78.4%) and showed an improvement of symptoms (p = 0.011). Conclusion: This observational study demonstrated that treatment with CR in unselected patients with climacteric complaints under the conditions of daily practice resulted in a significant improvement of menopausal symptoms assessed by the total KMI score and its sub-item scores with an effect size similar to that in a previous randomized, controlled clinical trial. © 2013 Elsevier GmbH. All rights reserved.
Schenk A.,Max Zeller Sohne AG |
Siewert B.,Max Zeller Sohne AG |
Toff S.,Max Zeller Sohne AG |
Drewe J.,Max Zeller Sohne AG
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2015
Due to increasing regulatory awareness of their hepatotoxic, genotoxic and possibly carcinogenic potential, pyrrolizidine alkaloid (PA) content has to be thoroughly monitored in herbal medicinal preparations. Recently, new very low PA regulatory threshold concentrations have been requested by the authorities. Therefore, a highly sensitive and reproducible UPLC TOF MS method for the quantification of the PAs senkirkine, senecionine, seneciphylline, senecionine-N-oxide and seneciphylline-N-oxide in a CO2-extract of Petasites hybridus leaves (Ze 339) has been developed.The limit of quantification (LOQ) was 2. ppb for all PAs. Recovery at the LOQ was between 88.9 and 141.9%, the repeatability precision between 3.5 and 13.6%. Linearity of the five PAs showed correlation coefficients between 0.9995 and 0.9998 and coefficients of variation between 7.44 and 8.56%. A working range between 2 ppb and 200 ppb could be fixed. In the tested batches of the P. hybridus extract Ze 339, the absence of PAs could be demonstrated. In conclusion, this assay allows to determine trace PA concentrations in P. hybridus extract Ze 339, making it suitable for analytical PA monitoring in accordance with regulatory requirements. © 2015 The Authors.
PubMed | Max Zeller Sohne AG
Type: | Journal: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences | Year: 2015
Due to increasing regulatory awareness of their hepatotoxic, genotoxic and possibly carcinogenic potential, pyrrolizidine alkaloid (PA) content has to be thoroughly monitored in herbal medicinal preparations. Recently, new very low PA regulatory threshold concentrations have been requested by the authorities. Therefore, a highly sensitive and reproducible UPLC TOF MS method for the quantification of the PAs senkirkine, senecionine, seneciphylline, senecionine-N-oxide and seneciphylline-N-oxide in a CO2-extract of Petasites hybridus leaves (Ze 339) has been developed. The limit of quantification (LOQ) was 2ppb for all PAs. Recovery at the LOQ was between 88.9 and 141.9%, the repeatability precision between 3.5 and 13.6%. Linearity of the five PAs showed correlation coefficients between 0.9995 and 0.9998 and coefficients of variation between 7.44 and 8.56%. A working range between 2 ppb and 200 ppb could be fixed. In the tested batches of the P. hybridus extract Ze 339, the absence of PAs could be demonstrated. In conclusion, this assay allows to determine trace PA concentrations in P. hybridus extract Ze 339, making it suitable for analytical PA monitoring in accordance with regulatory requirements.