Zusammenfassung
Pflanzliche Drogen und Extrakte müssen wie alle pharmazeutischen Ausgangsstoffe, die zur Herstellung von Arzneimitteln verwendet werden, eine geeignete pharmazeutische Qualität ...aufweisen. Entsprechende Qualitätsnormen werden in den Einzelmonographien des Arzneibuchs nach § 55 des deutschen Arzneimittelgesetzes beschrieben. Darin enthalten sind u. a. Informationen zu Inhaltsstoffen und Wirkstoffgehalt. In diesem Beitrag sollen zunächst die Entwicklung der Cannabisblütenmonographie für das Deutsche Arzneibuch (DAB) und die darin enthaltenen Qualitätsanforderungen und Lagerungsbedingungen beschrieben werden. Danach wird der Entwicklungstand von Monographien für das Europäische Arzneibuch dargestellt.
Bereits 2015 wurde mit den ersten Arbeiten an der Cannabisblütenmonographie für das DAB begonnen, nachdem bekannt geworden war, dass es gesetzliche Neuregelungen zur medizinischen Anwendung von Cannabisblüten und Cannabisextrakten geben würde. Zunächst wurde im Mai 2016 eine Monographie für Cannabisblüten im Deutschen Arzneimittel-Codex (DAC) veröffentlicht. Diese konnte im Mai 2017 durch die Publikation der DAB-Monographie ersetzt werden. Eine revidierte Version der DAB-Monographie ist seit April 2018 als nationaler Qualitätsstandard in Kraft getreten.
Derzeit wird eine harmonisierte Cannabisblütenmonographie für das Europäische Arzneibuch erarbeitet, die die nationalen Qualitätsstandards ersetzen soll. Außerdem werden im Deutschen Arzneibuch und nachfolgend im Europäischen Arzneibuch Monographien für Zubereitungen aus Cannabisblüten entwickelt. Mit harmonisierten Monographien im Europäischen Arzneibuch können zukünftig Mehrfachuntersuchungen nach jeweiligen nationalen Standards vermieden und Untersuchungen in Labors und Apotheken erleichtert werden.
Herbal drugs and extracts, like all pharmaceutical starting materials used in the manufacture of medicinal products, must have an appropriate pharmaceutical quality. Corresponding quality standards ...are described in the individual monographs of the pharmacopoeia according to § 55 of the German Drug Law. This includes information on ingredients and active substance content, among other things. This article describes the development of the Cannabis Flower Monograph for the German Pharmacopoeia (DAB) and the quality requirements and storage conditions contained therein. The state of development of monographs for the European Pharmacopoeia is also presented.After it was announced that there would be new legal regulations for the medical use of cannabis flowers and cannabis extracts, the first work on the cannabis flower monograph for the DAB began as early as 2015. First, a monograph on cannabis flowers was published in May 2016 in the German Drug Codex (DAC). The monograph was replaced in May 2017 by the publication of the DAB monograph. A revised version of the DAB monograph has been in force since April 2018 as a national quality standard.A harmonised cannabis flower monograph for the European Pharmacopoeia is currently being prepared to replace national quality standards. In addition, the German Pharmacopoeia and subsequently the European Pharmacopoeia develops monographs for preparations from cannabis flowers. In future, harmonised monographs in the European Pharmacopoeia will make it possible to avoid multiple testing according to the respective national standards and to facilitate analyses in laboratories and pharmacies.
An unconventional immobilization of dextransucrase via entrapment in alginate is described, which provides high activity yield and good operational stability. This method is normally restricted to ...the immobilization of complete cells or parts of cells. Experiments were designed to provide evidence for the immobilization mechanism. It was shown that a typical globular protein, α-chymotrypsin, is neither immobilized in an alginate matrix nor by formation of an additional network of dextran inside alginate. The results suggest that dextransucrase immobilization in alginate is due to a unique supramolecular structure.
Continuous leucrose formation with dextransucrase entrapped in calcium alginate beads was investigated. A plug-flow packed bed reactor was used as the reaction vessel and the conversion of sucrose as ...a function of residence time was measured at different initial sucrose concentrations. Leucrose productivity by the immobilized enzyme at different reaction conditions was determined and compared to the productivity of a discontinuous operation process. Productivities of the continuous process were in a range of 0.7–3.6 g U
−1 whereas only 0.7 g U
−1 could be reached in the discontinuous process; moreover, inactivation constants of the immobilized enzyme in the continuous operation mode were determined. The enzyme was continually inactivated with increasing reaction time. This was due to transport limitations inside the enzyme particles that could be confirmed by investigation of the swelling behavior of the enzyme beads due to the formation of dextran.
The synthesis and characterization of the monocationic cobalt(III) catecholate complex Co(L‐N4tBu2)(Cl2cat)+ (L‐N4tBu2=N,N’‐Di‐tert.‐butyl‐2,11‐diaza3.3(2,6)pyridinophane, ...Cl2cat2−=4,5‐dichlorocatecholate) are presented. The complex exhibits valence tautomeric properties in solution; but, in contrast to the usually observed conversion from a cobalt(III) catecholate to a high‐spin cobalt(II) semiquinonate state, valence tautomerism of Co(L‐N4tBu2)(Cl2cat)+ leads to the formation of a low‐spin cobalt(II) semiquinonate complex upon raising the temperature. This new type of valence tautomerism for a cobalt dioxolene complex has been unambiguously established by a detailed spectroscopic investigation using variable‐temperature NMR, IR and UV‐Vis‐NIR spectroscopy. Determination of the enthalpies and entropies characterizing the valence tautomeric equilibria in various solutions shows that the influence of the solvent is almost exclusively entropic.
A novel twist in temperature‐induced switching of electronic states in cobalt dioxolene complexes: Structural, magnetic, and spectroscopic results demonstrate that valence tautomerism can occur by converting a cobalt(III) catecholate into a low‐spin cobalt(II) semiquinonate complex instead of the usual high‐spin complex.
