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The use of whole blood cell cultures as a model for assessing the effects of SeptilinTM on the immune system.Hoosen, Mujeeb January 2017 (has links)
Magister Scientiae - MSc (Medical BioSciences) / In the past three decades there has been a huge increase in the use of herbal medicine globally.
The active principles of these herbal medicines are mostly unknown with supportive evidence for
safety and efficacy very rare. SeptilinTM is a phytopharmaceutical formulation which is
recommended for the treatment and management of various infections. It has been claimed to
have immunomodulatory actions that potentiates the body's immune response. The
immunomodulatory activity of SeptilinTM has not been well investigated via appropriate in vitro
models. Therefore this study was undertaken to investigate the in vitro effects of SeptilinTM on
biomarkers of specific immune pathways by using WBC. Stimulated and unstimulated WBC
were incubated with the product. Enzyme linked immunosorbent assays were used to screen for
IL-6, IL-10, and IFN? as biomarkers for inflammation, humoral immunity, and cell mediated
immunity, respectively. Results show that the presence of SeptilinTM in LPS stimulated WBC has
no effect on the release of IL-6 and IFN? production but stimulated IL-10 production. SeptilinTM
in unstimulated WBC has no effect on the release of IL-10 and IFN? production but stimulatory
effects on IL-6 production.
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Le médicament à base de plantes en Europe : statut, enregistrement, contrôles / Herbal medicinal products in Europe : status, registration, controlsLehmann, Hélène 05 April 2013 (has links)
La phytothérapie consiste en l’utilisation thérapeutique de plantes ou de médicaments à base de plantes, sous forme de spécialités pharmaceutiques, de préparations (magistrales ou officinales) ou de produits officinaux divisés. On entend par médicament à base de plantes (MABP) « tout médicament dont les substances actives sont exclusivement une ou plusieurs substances végétales ou préparations à base de plantes ou une association d’une ou de plusieurs substances végétales ou préparations à base de plantes ». Il s’agit donc de médicaments à part entière qui sont ainsi soumis aux mêmes exigences de qualité que celles requises pour tout autre médicament. La directive 2004/24/CE, permet toutefois quelques assouplissements autorisant à fournir des données toxicologiques et cliniques purement bibliographiques, lorsque les conditions requises pour pouvoir bénéficier d'un tel "enregistrement de l'usage traditionnel" sont remplies. Quant aux médicaments dont l'usage médical est "bien établi", ils peuvent également faire l'objet d'une dispense d'essais cliniques, mais les données toxicologiques les concernant doivent néanmoins être fournies. Cette législation européenne vise à garantir au patient la qualité, la sécurité et l'efficacité des remèdes qu'il consomme, à permettre le libre choix thérapeutique, la libre circulation des médicaments au sein de l’Union Européenne ainsi que la préservation des ressources naturelles végétales et le respect de la propriété intellectuelle et pourrait inspirer d'autres pays du monde qui ne disposent pas à ce jour des outils législatifs nécessaires à la réglementation de leurs remèdes traditionnels, en particulier les pays africains. / Herbal medicine consists in therapeutical use of plants or herbal medicinal products, in the form of patent medicines, magistral or pharmaceutical preparations or divided pharmaceutical products. It is meant by herbal medicinal product “any medicine the active substances of which are exclusively one or several herbal preparations or an association of one or several herbal substances or herbal preparations”. Herbal medicine are therefore full medicines and as such, they are submitted to the same quality requirements than those required for any other medicine. The directive 2004/24/EC of the European Parliament and ofthe Council of 31 March 2004 amending, as regards traditional herbal medicinal products, the directive 2001/83/EC on the Community code relative to medicinal products for human use, however permits some relaxings allowing to supply purely bibliographical toxicological and clinical data when the conditions required to be able to enjoy such a “traditional useregistration” are fulfilled. As regards herbal medicines the medicinal use of which have been proved as “well-established”, they are able to enjoy an exemption of clinical studies too, but toxicological data concerning these ones should nevertheless be produced. This European legislation aims to guarantee for the patient quality, safety and efficacy of the remedies he consumes, to permit free therapeutic choice and free movement of herbal medicines within the European Union, as well as preservation of natural vegetal resources (vegetal biodiversity) and respect of intellectual property of the traditional knowledges holders. It could be applicated in other countries like African countries, too.
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