Biosafety evaluation of medical injectable carboxymethyl glycosaminoglycan gel / 国际生物医学工程杂志

ABSTRACT

Objective:To evaluate the biosafety of medical injectable carboxymethyl glycosaminoglycan gel.Methods:Ames test, chromosome aberration test in vitro and gene mutation test in vitro were used to detect the genotoxicity of the medical carboxymethyl glycosaminoglycan gel. The gel saline extract (50 ml/kg) was injected slowly through the marginal vein of the ear into Japanese big-eared rabbits. The body temperature was measured and the temperature rise was calculated. The gel saline extract (50 ml/kg) and normal saline (control) were injected intraperitoneally and intravenously into the Kunming mice, respectively. The toxicity response in mice was observed after injection, and bodyweight change was valued. The gel saline extract, normal saline and distilled water were added into the rabbit anti-clotting, to detect the rate of hemolysis.Results:Under active and inactive conditions, the number of spontaneous revertants of the 4 strains of gel saline extract group and gel DMSO extract group did not reach 2 times of that of the corresponding negative control group. The rate of chromosome aberration of the three dose groups were 0. There was no significant increase in the large colony mutation frequency, small colony mutation frequency and total mutation frequency in three dose groups (all P>0.05). After injection of gel saline extract for 24, 48 and 72 h, no toxic reaction was found in each group of mice. With the extension of time after injection, the body weight of mice in the sample group and the control group increased, but the difference was not statistically significant ( P>0.05). After injection of gel saline extract, the temperature rise of 3 Japanese big-eared rabbits were 0.0, 0.3 and 0.2 ℃ respectively. The results of hemolysis test showed that the hemolysis rate of the polycarboxymethyl glucosamine gel was 0.1%. Conclusions:No genetic toxicity changes were found in carboxymethyl glycosaminoglycan to induce gene mutation or chromosome damage in bacteria and cells, and no pyrogenicity, acute systemic toxicity and hemolysis were observed. These results indicate that thecarboxymethyl glycosaminoglycan gel has good biosafety.