The microbial test-system based on cultivation of Halobacterium salinarum developed earlier for screening inhibitors of sterol biosynthesis and proposed for screening anticancer antibiotics, proved to be efficient in revealing anticancer compounds among derivatives of tris(1-alkylindol-3-yl)methylium, synthetic analogues of antibiotic turbomycin A. Most of the methane sulfonate and chloride salts of such compounds, investigated with the help of the H.salinarum test-system, showed no activity (MIC>32 mcM), while several derivatives, containing N-butyl or N-pentyl substituents were rather active against the bacterial strain. The MICs of them against H.salinarum were 8 mcM for total and 1 mcM for partial inhibition of the bacterial growth. The results of the study correlated with the results of other investigations that revealed anticancer activity of such compounds in tumor cell cultures. Therefore, the H.salinarum test-system demonstrated its availability for screening compounds with anticancer activity.

Toxicity and antiviral activity of aqueous extracts from higher mushrooms such as Lentinula edodes (Berk.) Pegler (shiitake), Pleurotus ostreatus (Jacq.) P. Kumm. (oyster), Inonotus obliquus (Ach. ex Pers.) Pilat (chaga), Hydnellum compactum (Pers.) P. Karst. (compact tooth) were studied. In doses of 0.8 to 4.0 mg (dry weight) per mouse administered orally or intraperitoneally the extracts showed no acute toxicity. When the dose of the chaga extract was increased to 20 mg per mouse, a half of the animals died. Intraperitoneal administration of the aqueous extracts in a dose of 0.4-2 mg per mouse prior to the contamination by a single LD₅₀ of Herpes simplex type 2 provided 100-percent survival of the animals exposed to the Lentinula edodes or Pleurotus ostreatus extracts and 90-percent survival of the animals exposed to the Inonotus obliquus or Hydnellum compactum extracts.

Prevalence and therapy of infections due to MRSA remain one of the most serious problems in the world. Therefore, correct laboratory identification of the MRSA phenotype based on the use of the marker antibiotic cefoxitine, as a more susceptibile one vs. oxacillin, is of great importance. There is lately being observed a tendency towards emergence of strains with lower susceptibility to the last reserve drugs protecting from MRSA, i. e. vancomycin amd daptomycin. Susceptibility of MSRA to these drugs was not investigated in Russia and there are no data on the prevalence of the VISA and hVISA phenotypes. The results of our study on estimation of susceptibility of 316 MRSA isolates from several regions of Russia to oxacillin, cefoxitine, vancomycin and daptomycin are presented herein. It was shown that the ranges of the oxacillin MIC were extremely wide, i. e. 0.5 to 512 mcg/ml, while 2.2±1% of the isolates was susceptible by the phenotype to oxacillin, in spite of the mecA gene presence. As for cefoxitine, the MRSA isolates were rather resistant to it at the MIC > 16 mcg/ml. The tests with serial microdilutions revealed that 30.7±7% of the isolates had a critical level of susceptibility to vancomycin at the MIC 2 mcg/ml. The E-tests revealed 1.3±1% of the isolates which were susceptible at the MIC 2-4 mcg/ml. The MRSA isolates were highly susceptible to daptomycin, while high levels of the MIC (2 mcg/ml) were characteristic of 2.8±1% of the isolates. Cross reduction of the susceptibility to vancomycin and daptomycin was observed.

The efficacy of a novel synbiotic drink in the complex therapy of patients with chronic diseases of the gastrointestinal tract and concominant intestinal dysbacteriosis was investigated in a randomized trial. The synbiotic drink contains a probiotic strain of bifidobacteria and Fucus evanescens polysaccharides with prebiotic activity and broad spectrum of the biological action on the patients. The use of the synbiotic drink provided more evident reduction of the clinical symptomes, more efficient recovery of the intestinаl microflora and higher percentage of the patients cure vs. the routine therapy and the therapy with inclusion of sour milk bifidobacterin.

Comparative placebo-controlled study entrolled 647 patients with verified diagnosis of chronic virus hepatitis B (HBeAg+), not previously subjected to antiviral therapy (with nucleotide analogues or interferons). The drug under the investigation was cycloferon, an earlier interferon inductor. The antiviral combination therapy of the main group patients (323 subjects) included the use of cycloferon + lamivudine for 48 weeks and the therapy of the control group patients (324 subjects) included the use of lamivudine + placebo for 48 weeks. The cycloferon and lamividine combination antiviral therapy was shown preferable vs. the lamivudine + placebo therapy by biochemical remission, virusological response, seroconversion by HBeAg by the 48th week of the treatment and HBsAg clearance. The conbination therapy provided lower frequency of the ralapses within 24 weeks of the observation. The higher efficacy of the antiviral combination therapy was evident of the impact of the antiviral activity of cycloferon itself and its immunomodulating and interferon-inducing activity on elimination of the virus-infected hepatocytes. The use of the 48-week course of the antiviral combination therapy is advisable as the prime treatment in the management of patients with HBeAg-positive chronic hepatitis not previously treated with nucleoside analogues and as a variant of therapy for lamivudine-refractory patients.

Complex clinical and laboratory examination of patients with HCV infection revealed that the use of cycloferon provided earlier normalization of the clinical and biochemical parameters and lower immunological imbalance vs. the basic therapy alone. High antiviral effect of the drug was shown. There was observed a positive impact of the cycloferon therapy on the late aftereffects hepatitis C, evidemt from higher frequency of the remissions in the patients with chronic hepatitis B and less frequent transformation of the acute form to the chronic one. Higher interferon-inducing and antiviral activities of cycloferon in the patients with acute hepatitis C and possible less frequent unfavourable aftereffects in the therapy with cycloferon in a dose of 500 mg were demonstrated.

Substances for manufacture of parenteral drugs require control by the «Bacterial Endotoxin» (BE) Index with the LAL-test. The aim of the study was to show possible applicability of organic solvents in BE determination by the gel-thromb test in case of water-insoluble pharmaceutical substances. The results confirmed that ethyl alcohol practically had no effect on the endotoxin activity. In the routine assays it is advisable to test solutions of the substances at the alcohol concentration of 6% below.

Ensuring quality, safety and efficacy of the medicinal products placed on the market of the Russian Federation constitutes the area that requires strict regulation. When changes are made to the manufacturing process, the manufacturer generally needs to evaluate the relevant quality attributes of the product to demonstrate that modifications did not occur that would adversely impact the safety and efficacy of the drug. Where there is the lack of a sound legal basis, there is a need in harmonization of current Russian legislation with international and European rules governing medicinal product for human use to ensure quality, safety and efficacy thereof.