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Purpose. To evaluate the efficacy of a fixed combination of sodium hyaluronate, D-panthenol, chondroitin sulfate sodium (SH+D+CS) and a tear substitute based on sodium hyaluronate (SH) in the correction of post-LASIK ocular surface changes. Material and methods. The study involved 60 patients with moderate myopia (before and after LASIK). In the group 1 (30 patients, 30 eyes) the SH+D+CS combination was instilled postoperatively 3-5 times daily, in the group 2 (30 patients, 30 eyes) SH – 3-5 times daily. Ophthalmological examinations, a detection and an evaluation of dry eye (DE) symptoms, tear film break up time (TFBT), optical coherence meniscometry, evaluation of xerosis index (XI) (lyssamine green staining) were performed in all the patients. Results. Significant ocular surface changes were identified in both groups in the postoperative period: DE symptoms, decrease of TFBT, decrease of lower tear meniscus height (LTMH), increase of XI. The DES therapy was effective in both groups. At the same time, significantly more pronounced increase of TFBT and LTMH (10 and 40 days after LASIK, p< 0.05) as well as a significantly more pronounced decrease of XI (40 days after LASIK, p< 0.05) were noted in the group 1. Conclusion. Thus, the application of the fixed combination of SH+D+CS allows to achieve significantly more pronounced improvement of ocular surface conditions in the post-LASIK status than the application of a tear substitute based on SH.

We developed and optimized a novel gene delivery vector constructed electrostatically with an anionic biological component and a cationic biological component. Cationic binary complexes of plasmid DNA (pDNA) with novo-protamine sulfate as a medical product (PRT complexes) demonstrated high gene expression with minimal cytotoxicity, likely related with its total cationic charge. Subsequently, anionic compounds were added to the PRT complexes to form ternary complexes with neutral or anionic charges. Among the anionic compounds examined, chondroitin sulfate sodium (CS) as a medical product encapsulated the PRT complexes to produce stable ternary complexes (CS complexes) at charge ratios of ?4 with pDNA. CS complexes exhibited high gene expression without cytotoxicity in mouse melanoma cell line, B16-F10 cells, in vitro. An inhibition study with endocytosis inhibitors suggested that PRT complexes were mainly taken up by caveolae-mediated endocytosis, and CS complexes were mainly taken up by clathrin-mediated endocytosis in B16-F10 cells. We found that CS complexes including pDNA encoding Oplophorus gracilirostris luciferase induced selective gene expression in the spleen after intravenous administration into ddY male mice. Thus, we successfully constructed useful gene vectors with biological components as medical products., Biological and Pharmaceutical Bulletin, 41(3), pp.342-349; 2018

Chondroitin sulfate, an amino sugar polymer made of glucuronic acid and N-acetyl-galactosamine, is used in dietary supplements to promote joint health. Commonly used chondroitin sulfate is of animal origin and can pose potential safety problems including bovine spongiform encephalopathy (BSE). The objective of the present study was to investigate potential adverse effects, if any, of microbial derived chondroitin sulfate sodium (CSS) in subchronic toxicity, genotoxicity and bioavailability studies. In the toxicity study, Sprague Dawley rats (10/sex/group) were gavaged with CSS at dose levels of 0, 250, 500 and 1000 mg/kg body weight (bw)/day for 90-days. No mortality or significant changes in clinical signs, body weights, body weight gain or feed consumption were noted. Similarly, no toxicologically relevant treatment-related changes in hematological, clinical chemistry, urinalysis and organ weights were noted. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. In vitro mutagenic and clastogenic potentials as evaluated by Ames assay, chromosomal aberration test and micronucleus assay did not reveal genotoxicity of CSS. In pharmacokinetic study in human, CSS showed higher absorption as compared to chondroitin sulfate of animal origin. The results of subchronic toxicity study supports the no-observed-adverse-effect level (NOAEL) for CSS as 1000 mg/kg bw/day, the highest dose tested.