Search

Chondroitin sulfate sodium is an acidic mucopolysaccharide extracted from animal cartilage, and has been widely used in the world as anti-osteoarthritis and health food. It is difficult to control the quality and safety of chondroitin sulfate sodium, due to the structure, physical and chemical characteristics, physiological activities of chondroitin sulfate sodium vary with the different animal species, tissues and extraction processes. There are corresponding standards for chondroitin sulfate sodium at home and abroad. Based on the raw material standards of chondroitin sulfate sodium collected in the pharmacopoeia of China, the United States, Japan and Europe, this paper analyzes and summarizes the development status and trend of quality and safety standardization of chondroitin sulfate sodium. Combined with the latest research results, the critical control points affecting the quality and safety of chondroitin sulfate sodium are further extracted, and the sources, potential exogenous pollutants and adulteration are deeply analyzed and discussed, which is conducive to accurately grasp the risk sources affecting the quality and safety of chondroitin sulfate sodium for the supervision department and production enterprises. This paper clarifies the future requirements of quality and safety standardization of chondroitin sulfate sodium, providing reference for the continuous improvement of quality and safety standard system of chondroitin sulfate sodium.

Non-pigmenting fixed drug eruption (NPFDE) is a subtype of fixed drug eruption (FDE) in which repeated eruptions occur at the same site. Clinically, NPFDE disappears without pigmentation changes; however, it sometimes causes fever or arthralgia. Its histopathological characteristics reportedly include infiltrations of CD8-positive T cells with a paucity of melanocytes as compared to FDE. We present the first case of severe NPFDE exhibiting general symptoms caused by chondroitin sulfate sodium. The patient was a 44-year-old man. Intravenous injection of chondroitin sulfate sodium caused erythema in the affected area. A histopathological examination of the biopsy tissue revealed infiltration of CD3-positive lymphocytes (both CD4-positive and CD8-positive lymphocytes) into the epidermis, minimal liquefaction degeneration in the basal layer of the epidermis, and few dermal melanophages, which may be responsible for non-pigmentation.

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. [ABSTRACT FROM AUTHOR]

Abstract: An ion-pair high-performance liquid chromatography (HPLC) method has been developed for the simultaneous determination of chondroitin sulfate sodium (CSS), allantoin and pyridoxine hydrochloride (VB6) in a commercial eye drops dosage form. An Alltima C18 column (250mm×4.6mm i.d., 5μm) was used for the separation at room temperature, with 25mM ammonium dihydrogen phosphate (containing 0.01% heptanesulfonic acid sodium salt) and acetonitrile (95:5, v/v) as the mobile phase at the flow rate of 0.5mLmin−1. The detection wavelength for CSS, allantoin and VB6 was 195nm, 215nm and 291nm, respectively. The method showed good linearity for CSS, allantoin and VB6, with correlation coefficients greater than 0.9996, in the range of 203.96–815.84mgL−1, 371.16–1488.64mgL−1, and 23.32–93.28mgL−1, respectively. The instrumental and method precisions were adequate with all relative standard deviations lower than 2.0%. The accuracy of this method, measured by the recovery of three compounds from spiked placebo solutions, was from 99.01% to 101.92%. The three components, CSS, allantoin and VB6 were well separated from other ingredients and degradation products. This method is fast, simple, and can be used for direct and simultaneous determination of CSS, allantoin and VB6 in the pharmaceutical preparation. [Copyright &y& Elsevier]

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.