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In spite of the cost reduction policy of the health care system and drastic restrictions imposed by public health and environmental authorities, the development of innovative remedies is still the basis for growth and success of pharmaceutical companies. This also concerns the producers of extracts and herbal medicinal products. In this report the so-called basis and step innovations have been defined and adequate examples have been presented. An essential prerequisite for the development of such innovative herbal medicinal products is the preservation of reimbursement by state health plans. Owing to their good tolerability, herbal medicinal products are an indispensable alternative to chemical-synthetic drugs, especially in the long-term treatment of chronic diseases. As the intended exclusion of non-prescription medicines from reimbursement by state health plans (German health care system modernisation Law) primarily concerns the innovative HMPs, future development in this field seems to be hindered or even blocked. On account of the high costs of development as well as the incalculable investment risks described in this report, future development of herbal medicinal products will only be affordable for extract and herbal medicinal product manufacturers if an essential political and legal framework of the health care system is guaranteed on a European level.
According to the European Directive 2001/83/EC, medicinal products, contrary to foodstuffs, require a pre-marketing authorisation by competent authorities. Quality has to be proven in accordance with the European directives and guidelines, while safety and efficacy through pharmacological- toxicological and clinical studies and/or bibliographic application (Art. 10.1 (a) (ii)). Apart from these options, some European countries have established a simplified proof of efficacy, e.g. for traditional herbal medicinal products. The study of AESGP (European Medicines Manufacturers’ Association), “Herbal Medicinal Products in the European Union”, which was performed in 1998 on behalf of the European Commission, elucidates the regulatory situation in member states of the European Union, in particular the implementation of the option of bibliographic application. ESCOP, the European Scientific Cooperative on Phytotherapy, has published 80 monographs on the medicinal use of herbal drugs in order to provide harmonised criteria of assessment on a European level. A similar project has been initiated by the World Health Organisation (WHO). The Herbal Medicinal Products Working Party (HMPWP) at the European Agency for the Evaluation of Medicines (EMEA) has published various guidelines on the quality, safety and efficacy of herbal medicinal products, e.g. the so-called core-data on herbal drugs based on monographs.Apart from the area of the ‘well-established medicinal use’ products suitable for bibliographic applications, a further category of traditionally used herbal medicinal products is being established on a European level. The European directive on traditional herbal medicinal products amending Directive 2001/83/EC provides the option of a simplified registration procedure under certainconditions, e.g. established safety, plausible efficacy on the basis of long-term use and experience as well as proven quality. A new Committee for Herbal Medicinal Products is being founded which is to be responsible for the preparation of Community herbal monographs on products with well- established medicinal use and on traditional herbal medicinal products. The parties involved hope that further discussion in ESCOP/ WHO monographs and the preparation of new core-data takes place as a basis for well-established medicinal use in order to facilitate mutual recognition and to achieve a European-wide rational assessment for all kinds of herbal medicinal products.
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The antibacterial activity of Eclipta alba against three gram positive and five gram negative bacterial strains was investigated. The fresh whole plants were collected from Chidambaram, Tamil Nadu. Petroleum ether, chloroform, ethyl acetate, acetone, methanol and aqueous extracts at different concentrations (1, 2, 5, 10 mg/ml) were used to investigate the antibacterial activity. NCCL standards were strictly followed to perform antibacterial disc susceptibility test using disc diffusion method. The extracts showed varying degree of inhibitory potential against all the tested bacteria. Methanol extract of the plant had higher inhibitory action against Staphylococcus aureus, Bacillus subtilis, Proteus mirabilis and Pseudomonas fluroescens.
Out of 750,000 known plants in the world, a major part are medicinal and aromatic plants – a source of raw material for folk and documented systems of medicines worldwide. The folk and documented medicine in India use about 6,000 plants, although, less than 50 species have been scientifically studied and cultivated to any sizeable extent. The main factor behind the slow pace of domestication of medicinal plants is the absence of knowledge on cultivation practices and lack of suitable technology. About 90% of the medicinal plants for trade are harvested from the wild and the demand for traditional medicinal plants is increasing rapidly. Continuous exploitation of several medicinal plant species from the wild has resulted in their population decline. Hence, an effective strategy is needed for their sustainable utilization and conservation. Cultivation is the most effective way of conservation. Cultivation can also ensure production of standardized raw materials. Thereby, enhances the quality of the manufactured products. The methods and techniques of modern chemical agriculture cannot be adopted for the cultivation of medicinal plants as they should be free from harmful residues. Pesticides and other harmful chemicals have been detected in some herbal products. Hence, to ensure a safe, residue-free and reliable material for use in herbal drug industry, there is an urgent need to adopt strategies for cultivation of medicinal plants that are consistent with principles of good agricultural practices.
Arnica sp. infusions and tinctures play a great role in the traditional and contemporary medicine. Seeds of plantation-grown Arnica montana L. (AM) and Arnica chamissonis var. foliosa Less. (AC ) are a good source of bioactive compounds such as phenolic acids and flavonoids. In both studied genera higher levels of phenolic acids and flavonoids were detected in water extracts. Regardless of plant genus, predominant fractions of phenolics were determined in seeds, comprising chlorogenic, caffeic acid, quercetin and kaempferol. All samples show high antioxidant activity, however, their levels depend on the extraction procedure and used material. The free radicals were scavenged most effectively by extracts of AC seeds (30.3% – SASA, 31.3% – DPPH and 39.8% – ABTS, respectively). It should be noted that lipid peroxidation was strongly inhibited by both studied tinctures. It is noteworthy that studied samples show positive correlations between inhibition of lipid peroxidation ability and total flavonoids and phenolic acids content (r=0.89 and r=0.83, respectively). Results obtained from this study show that Arnica seeds extract, either alone or in combination with other active principles, can be used in cosmetic, nutraceutical and pharmaceutical applications.
W wybranych ziołach jedno- i wieloskładnikowych, wyciągach wodnych z tych ziół (w naparach i odwarach) oraz w płynnych postaciach leków ziołowych oznaczono zawartość niklu za pomocą absorpcyjnej spektrometrii atomowej.
Metodą Griessa-Ilosvay'a oznaczono poziomy azotanów(III) i (V) w preparatach i lekach ziołowych stosowanych w leczeniu chorób układu oddechowego oraz chorób układu moczowego.
A post-marketing surveillance study (PMSS) was carried out in Poland with 313 childrei aged 3-10, predisposed to upper respiratory tract infections. The study participant received Bioaron C® syrup, containing aqueous extract of Aloë arborescens leaves, juice o Aronia melanocarpa fruit and ascorbic acid. The main object of the present study was ti investigate its tolerability and influence on the course of an acute URTI in children. Amon; the study participants 14% received Bioaron C® as a single medication and 86% of thi patients received concomitant medications. The efficacy of the treatment was measurei according to a validated symptom score. The best results were obtained for symptom related to rhinitis and bronchitis but there was no major effect seen on pain and fevei Within the subscores rhinitis and bronchitis Bioaron C alone was able to lead to ai improvement and could contribute to a reduction in particular of the single symptom blocked and runny nose, cough and hoarseness. Treatment with Bioaron C resulted in a sig nificant improvement of the symptomology of URTI. Bioaron C was tolerated very well.
One of alternative strategies in prevention and therapy of Benign Prostatic Hyperplasia (BPH) is the usage of a number of traditional herbal plants. In recent years, there is an increasing interest in some members of the Epilobium genus in the treatment of BPH. So far there is no data about molecular mechanisms of action of Epilobium angustifolium L. extracts in liver. The aim of this study was to investigate the influence of the standardized water extract from the Epilobium angustifolium L. on expression level of selected P450 cytochromes encoding genes (CYP3A1 and CYP7A1) in rats liver tissues, which protein products are involved in steroids metabolism. The most abundant fraction of active compounds obtained from the extract was a phenolic fraction (24.36% m/m phenolic compounds and small amounts of flavonoglycosides – 0.91% and sterols – 0.09%). The plant extract showed the strongest and significant inhibitory CYP3A1/2 mRNA expression effect in rat liver. Our results suggest that a standardized E. angustifolium extract can regulate transcription level of investigated CYP genes in a different manner since a strong inhibition of CYP3A1 mRNA expression and slight induction of CYP7A1 may be a result of different extract action on the investigated CYP’s transcription machinery in rat liver cells.
Określono poziomy azotanów(III) i (V) w popularnych fitoterapeutykach stosowanych w leczeniu chorób wątroby i dróg żółciowych oraz w ich naparach i odwarach. Oznaczenia wykonywano metodą Griessa-Ilosvay 'a z zastosowaniem kolumny kadmowej. Obliczono również zawartość tych związków w maksymalnej dobowej dawce terapeutycznej.
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