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.
ABSTRACT
Objective To investigate clinical significance of soluble CD30/CD30L and CD40/CD40L system imbalance in ovarian serous tumors.Methods 40 patients of serous cystadenoma and 30 patients of serous cystadenocarcinoma were selected,and 40 age-and weight-matched healthy women were also recruited as the control group.Peripheral venous blood (3 ml) of the healthy control and patients with ovarian serous tumors before surgery and 7 days after surgery were collected.After separation of serum,ELISA was used to detect levels of sCD30,sCD30L,sCD40 and sCD40L.Results Compared to the control group,levels of sCD30,sCD30L,sCD40 and sCD40L in both serous cystadenoma and serous cystadenocarcinoma groups were significantly in creased (P＜0.05).And in those serous cystadenocarcinoma group,levels of such soluble proteins were much higher than in serous cystadenoma group (P＜0.05).7 days after surgery,levels of such soluble proteins were significantly decreased in both serous cystadenoma and serous cystadenocarcinoma groups (P＜0.05).Conclusion Detection of serum sCD30/sCD30L and sCD40/sCD40L is possible to have a certain guiding significance to early diagnosis of ovarian tumors and the prognosis of patients.
ABSTRACT
Multiple kinds of Artificial Skin Substitute are now available. However, except for the Homo Skin Graft there is no Artificial Skin Substitute that can be used as permanent Artificial Skin Substitute. During the past 20 years, more and more scholars around the world have expressed increased interests in the research and development of Artificial Skin Graft that can be utilized as satisfying permanent Artificial Skin Substitute. We conducted our research on the biological evaluation of medical devices of Collagen-Chitosan(C-C) Artificial Skin Substitute according to the National Standard (GB/T16886. 1-1997). The following experiments were conducted: (1)Cytotoxicity, (2)Systemic toxicity(acute toxicity), (3)Haemocompatibility, (4)Sensitization, (5)Intracutaneous reactivity, (6)Pyrogen test, (7)Genotoxicity. The experiment results demonstrate that all biological functional indexes of the Artificial Skin Graft meet the National Standards. Therefore, we conclude that C-C Artificial Skin Graft is characteristic of good biological compatibility. It is non-irritant and has no systemic and cellular toxicity, no genotoxicity, no pyrogen, and no allergen.