Background: Valerian (Valeriana officinalis) and Hops (Humulus lupus) are famous herbs in throughout world. Both medicinal herbs have been used for insomnia in European, Asian traditional medicine for centuries. Valmedin consists from mixed herb extracts of Valerian and Hops. It possess antidepressant, anti-anxiety effect, and improves sleep efficiency. Aim : The aim of this study was to evaluate quality control parameters for standardization of Valmedin pellet and assess toxicity of Valmedin pellet. Methods: In the present study pellets was prepared by extrusion-spheronization technique. The pellet size was determined by sieve analysis using sonic separator. The extract of Valmedin formulation was prepared in pellet (dragee). Valmedin pellet was subjected to analysis for physiochemical parameters, phytochemical studies, heavy metals and quality parameters according to Mongolian pharmacopoeia (2002,). The lethal dose at 50% (LD50) was calculated according to Prozorovskii. In the test chronic toxicity was used two doses of the concentrated extract of Valmedin (0.25; 0.5 g/kg) and assessed parameters (ALT, ALP, AST, bilirubin, total protein, TNFα, IL-6). Result: First of all, the quality of biological active components and physiochemical parameters of individual herbs including Valerian, Hops and Metha L have been fulfill the basic requirements of standardization herbal medicines. Moisture content of Valmedin pellets was 1.6 ±0.01%. Total tannin and valerenic acid content found to be 0.051±0.05, 0.71±0.02% for a pellet. Levels of heavy metals was within the permissible range of standard.
In the acute toxicity study, the LD50 value of the concentrated extract from Valmedin was 1.56 g/kg (i.p). No significant changes in body weights of treated animals. In the hematological and biochemical analyses of Valmedin in dose of 250 mg/kg has shown no significant change in the levels of ALT, AST, ALP and levels of RBC and WRC counts in blood serum. Valmedin at dose of 500 mg/kg after chronic injection lower sign levels of ALT, ALP enzymes, and total protein compared with the control group I. It increases significantly levels of AST enzyme, glucose in blood serum. By hematological analyses, Valmedin in dose of 500 mg/kg elicited decrease in the level of hematological parameters such as white blood cells and red blood cells count in whole blood. Likewise, treatment of Valmedin in doses of 250 and 500 mg/kg did not induce any change in the levels of TNF and IL-6 cytokines. Conclusion Pellets of Valmedin containing Valerian, Hops, and Metha were successfully made achieving degrees of quality, physical stability compatible with the requirements for standardization and formulation.