Neamon-hepa capsules - pharmaceutical preclinical and clinical studies

Abstract

Introduction: Neamon-hepa combination drug preparation, capsules, developed at the Scientific Center of Drug Research of the State University of Medicine and Pharmacy “Nicolae Testemitanu” contains the following active ingredients: arginine aspartate, spironolactone and BioR (extract of Spirulina platensis biomass), firstly proposed as a combination drug. Matherials amd methods: Preparation of dosage of Neamon-hepa capsules: weight and volume measurement of the components, lactose impregnation with BioR, and drying of lactose with BioR and pulverization of dry mixture, preparation of mixes: I (spironolactone: anhydrous lactose in 1:2 ratio), II (mix the mix I with lactose impregnated with BioR), III (mix the mix II with cornstarch, microcrystalline cellulose, magnesium stearate), IV-final (mix the mix III with dry L-arginine aspartate), conditioning in capsules. Results: Efficacy and safety of the product was demonstrated by clinical experiments on a group of 56 mice by determining the acute and chronic toxicity in toxic hepatitis model induced by CC14 (carbon tetrachloride). The results indicate that in laboratory animals with induced chronic liver damage, receiving Neamon-hepa preparation, declined significantly body mass, decreased hepatomegaly, improved functional status of liver expressed by reduced total bilirubin, ALT, AST alkaline phosphatase, and serum cholesterol lactatdehydrogenase. Neamon-hepa, has undergone clinical trials, according to the protocol on 55 patients (men and women, aged 18-61 years) with liver cirrhosis B and D of viral etiology, stage Child-Pugh A. Patients were subjected to clinical, laboratory and instrument examination. Data from this study indicates the efficacy and safety of Neamon-Hepa in the treatment of liver cirrhosis and chronic hepatitis, characterized by its hepatoprotective property, evidenced through improved liver function capacity (cytolytic index improvement) and reduction of portal hypertension. Conclusion: Biopharmaceutical research showed a high bioavailability of active substances, which proves the adecuate selection of dosage form and correct pharmacotehnologic processes. Preclinical and clinical studies have shown that Neamon-hepa, capsules can be used in the treatment of chronic viral hepatitis and liver cirrhosis. The drug has a polyfunctional action and a spectrum of activity that is intended to provide a multidirectional therapeutic complex effect.