Chinese Journal of Tissue Engineering Research ›› 2019, Vol. 23 ›› Issue (10): 1570-1574.doi: 10.3969/j.issn.2095-4344.1632

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Biosafety of medical injectable carboxymethyl glycosaminoglycan anti-adhesion gel

Gao Ping1, Cheng Lin1, Chen Bin1, Li Ruizhi2, Li Xin1, Shi Mengrou1, Li Guangyuan1, Cheng Peng1, Li Dongfeng2, Yu Huan2, Wang Xiaohui1   

  1. 1Tianjin Institute of Pharmaceutical Science, Tianjin 300020, China; 2Imeik Technology Development Co., Ltd., Beijing 100022, China
  • Received:2018-11-29
  • Contact: Wang Xiaohui, Associate researchers, Tianjin Institute of Pharmaceutical Science, Tianjin 300020, China
  • About author:Gao Ping, Associate researcher, Tianjin Institute of Pharmaceutical Science, Tianjin 300020, China

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.

 

Key words: Materials Testing, Gels, Tissue Adhesions, Tissue Engineering

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