Biosafety of medical injectable carboxymethyl glycosaminoglycan anti-adhesion gel
10.3969/j.issn.2095-4344.1632
- VernacularTitle:医用可注射羧甲基葡糖胺聚糖防粘连凝胶的生物安全性评价
- Author:
Ping GAO
1
;
Lin CHENG
;
Bin CHEN
;
Ruizhi LI
;
Xin LI
;
Mengrou SHI
;
Guangyuan LI
;
Peng CHENG
;
Dongfeng LI
;
Huan YU
;
Xiaohui WANG
Author Information
1. 天津市医药科学研究所
- From:
Chinese Journal of Tissue Engineering Research
2019;23(10):1570-1574
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND: The injectable carboxymethyl glycosaminoglycan anti-adhesion gel prepared in the previous study combines the advantages of anti-adhesion membrane and anti-adhesion liquid. It can form soft gel in situ in a relatively short time, which is not affected by body position, bear the pressure of surrounding tissues and can be used without compression. OBJECTIVE: To evaluate the biocompatibility of medical injectable carboxymethyl glycosaminoglycan anti-adhesion gel. METHODS: Logarithmic growing L929 cells were used as test cells, and the cytotoxicity of injectable carboxymethyl glycosaminoglycan anti-adhesion gel extract was detected by MTT method. The intradermal stimulation test of injectable carboxymethyl glycosaminoglycan anti-adhesion gel extract was carried out in Japanese big ear rabbits. Guinea pigs were used as experimental animals to carry out intradermal induction and local induced delayed hypersensitivity test of injectable carboxymethyl glycosaminoglycan anti-adhesion gel extract. Wistar rats were used as experimental animals to carry out the subchronic toxicity test of injectable carboxymethyl glycosaminoglycan anti-adhesion gel extract. RESULTS AND CONCLUSION: The cytotoxicity of injectable carboxymethyl glycosaminoglycan anti-adhesion gel extract was grade 1, meeting the standard requirements. Injectable carboxymethyl glycosaminoglycan anti-adhesion gel extract had no potential intradermal stimulation and no potential skin sensitization. In the subchronic toxicity test, the rats were subjected to the tail vein injection of injectable carboxymethyl glycosaminoglycan anti-adhesion gel extract for 28 continuous days, and there was no obvious subchronic systemic toxicity in body mass, hematology, coagulation function, blood biochemistry and visceral pathology. These results indicate that the injectable carboxymethyl glycosaminoglycan anti-adhesion gel has good biosafety.
