Arzneimittel Forsch
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Arzneimittel Forsch · Jan 2004
Randomized Controlled Trial Comparative Study Clinical TrialBioavailability study of drotaverine from capsule and tablet preparations in healthy volunteers.
The bioavailability of drotaverine (CAS 14009-24-6) was investigated after oral administration of a drotaverine capsule preparation (20 mg Droxa mite) and compared to that of a reference tablet preparation. The preparations were investigated in 23 healthy volunteers, aged between 20 and 27 years, according to a randomised two-way, cross-over design in the fasted state. Blood samples for determination of drotaverine plasma concentrations were collected at pre-defined time points up to 30 h following drug administration. ⋯ AUC was calculated using two different methods. There were no significant differences between the obtained values. Since the 90% CI for both, AUC and Cmax ratios were within the 80-125% interval proposed by the European Agency for the Evalution of Medicinal Products (CPMP) and the Food and Drug Administration, it is concluded that the new drotaverine capsule formulation is therapeutically equivalent to the conventional formulation for both, the extent and the rate of absorption after single dose administration in healthy volunteers.
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Arzneimittel Forsch · Jan 2004
Influence of peroral application of a herbal immunomodulator on the antibody production of Peyer's patches cells.
The influence of the peroral administration of the macromolecular components of a herbal immunomodulator isolated from an aqueous-ethanolic extract of the mixed herbal drugs Thujae summitates, Baptisiae tinctoriae radix, Echinaceae purpureae radix and Echinaceae pallidae radix on the function of Peyer's patches cells was investigated in mice. Peyer's patches cells isolated from mice which had received oral administration of the macromolecular fraction of the plant extract developed a significantly enhanced plaque-forming cell (PFC) response to sheep red blood cells after incubation with these cells in the presence of lipopolysaccharide or the extract fraction for 7 days in vitro. These results show that after oral administration of the herbal immunomodulator, the immunologically active macromolecules can contact the cells of the gut-associated lymphoid tissue and modulate the mucosal immune response.
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Arzneimittel Forsch · Jan 2003
Randomized Controlled Trial Clinical TrialSynergetic analgesic effect of the combination of arnica and hydroxyethyl salicylate in ethanolic solution following cutaneous application by transcutaneous electrostimulation.
A combination of the active agents arnica and hydroxyethyl salicylate (HES) in ethanolic solution (Sportino Acute Spray) is cutaneously applied for the treatment of sports injuries and diseases of the locomotor apparatus. The aim was to examine the efficacy and synergism of the single substances and the combination with regard to the analgesic effect after cutaneous application as well as to validate the method of transcutaneous electronic stimulation as a method of measuring the analgesic effect. ⋯ In addition, the effect of the vehicle ethanol and the reference substance water could be determined within the framework of these comparative experiments and the difference between the combination preparation and the individual substances arnica and HES could be shown. The method of transcutaneous electrostimulation used for the objective measurement of the analgesic effect was validated.
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Arzneimittel Forsch · Jan 2003
Clinical TrialIncidence of pain after intravenous injection of a medium-/long-chain triglyceride emulsion of propofol. An observational study in 1375 patients.
To assess incidence and intensity of pain on intravenous injection of propofol (CAS 2078-548) in an emulsion of medium-chain/long-chain triglycerides (MCT/LCT, 50:50) in patients undergoing different elective surgical interventions. ⋯ The incidence of pain on injection of a medium-/long-chain triglyceride propofol formulation was 28.4% with 16.7% of the patients reporting mild pain. The use of an antecubital vein or a large size venous cannula appears to reduce the injection pain.
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Arzneimittel Forsch · Jan 2003
Synthesis and anticonvulsant activity of some new dioxolane derivatives.
In this study, ten 2-acetylnaphthalene derivatives with a dioxolane structure were synthesized and screened for their anticonvulsant activities. Dioxolane derivatives were prepared by the reaction with appropriate ethanone, glycol and p-toluensulphonic acid. The structures of the compounds were elucidated by IR, 1H-NMR and elemental analysis. ⋯ The rotarod toxicity test was used for the assessment of neurological deficits. According to the activity studies compound 6 was found neurotoxic, compounds, 1, 4, 5, 7-9 were found protective against MES and 7-10 were found protective against ScMet. Compounds 2 and 3 were found inactive.