Quality Assessment of Medicinal Product and Dietary Supplements Containing Vitex agnus-castus by HPLC Fingerprint and Quantitative Analyses.

In this study, we aimed to evaluate the quality of 11 products sold in Japan (one medicinal product and 10 dietary supplements) containing/claiming to contain chasteberry extract (fruit of Vitex agnus-castus L.) using HPLC fingerprint (15 characteristic peaks), quantitative determination of chemical marker compounds, and a disintegration test. The HPLC profile of the medicinal product was similar to that of the reference standard of V. agnus-castus fruit dry extract obtained from European Directive for the Quality of Medicines (EDQM), whereas the profiles of some dietary supplements showed great variability, such as different proportions of peaks or lack of peaks. Results of the principal component analysis of the fingerprint data were consistent with those of the HPLC profile analysis. The contents of two markers, agnuside and casticin, in dietary supplements showed wide variability; this result was similar to that achieved with the HPLC fingerprint. In particular, agnuside and/or casticin was not detected in two dietary supplements. Furthermore, one dietary supplement was suspected to be contaminated with V. negundo, as evidenced from the results of agnuside to casticin ratio and assay of negundoside, a characteristic marker of V. negundo. Results of the disintegration test showed poor formulation quality of two dietary supplements. These results call attention to the quality problems of many dietary supplements, such as incorrect or poor-quality origin, different contents of the active ingredient, and/or unauthorized manufacturing procedures.

In vitro and in vivo effects of a novel bioactive glass-based cement used as a direct pulp capping agent.

Direct pulp capping is an important procedure for preserving pulp viability. The pulp capping agent must possess several properties, including usability, biocompatibility, and the ability to induce reparative dentin formation. In this study, a novel bioactive glass-based cement was examined to determine whether the cement has the necessary properties to act as a direct pulp capping agent. Physicochemical properties of the bioactive glass-based cement and in vitro effects of the cement on odontoblast-like cells, as well as in vivo effects on the exposed dental pulp, were analyzed. The cement immersed in water stabilized at pH10, and hydroxyapatite-like precipitation was induced on the surface of the cement in simulate body fluid. There were no cytotoxic effects on the viability, alkaline phosphatase activity, or calcium deposition ability of odontoblast-like cells. In the in vivo rat study of an exposed dental pulp model, the cement induced a sufficient level of reparative dentin formation by odontoblast-like cells expressing odontoblastic markers at the exposed area of the dental pulp. These results suggest that the newly developed bioactive glass-based cement provides favorable biocompatibility with the dental pulp and may be useful as a direct pulp capping agent. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 107B: 161-168, 2019.

Preparation of gelatin hydrogel sponges incorporating bioactive glasses capable for the controlled release of fibroblast growth factor-2.

Gelatin hydrogel sponges incorporating bioactive glasses (Gel-BG) were fabricated. We evaluated the characteristics of Gel-BG as scaffolds from the perspective of their mechanical properties and the formation of hydroxyapatite by the incorporation of bioactive glasses (BG). In addition, the Gel-BG degradation and the profile of fibroblast growth factor-2 (FGF-2) release from the Gel-BG were examined. Every Gel-BG showed an interconnected pore structure with the pore size range of 180-200 µm. The compression modulus of sponges incorporating BG increased. The time profiles of degradation for the 72-h crosslinked gelatin hydrogel sponges incorporating 10 wt% BG (Gel-BG(10)) and 50 wt% BG (Gel-BG(50)) were analogous to that of the 24-h crosslinked gelatin hydrogel sponge without BG (Gel-BG(0)). In measuring the release of FGF-2 from Gel-BG, the Gel-BG(10) and Gel-BG(50) showed almost analogous 100% cumulative release within 28 days in vivo. Additionally, a bioactivity evaluation showed that the presence of gelatin does not affect the in vitro bioactivity of Gel-BG. These sponges showed mechanical and chemical functionality as scaffolds, featuring both the controlled release of FGF-2 and the induction of hydroxyapatite crystallization.