Dose- and time-dependent systemic adverse reactions of sodium carboxy methyl cellulose after intraperitoneal application in rats

Chunguang Fan; Li Hou; Guoxi Che; Yanping Shi; Xiangdong Liu; Likui Sun; Wensi Jia; Fuyu Zhu; Zenglin Zhao; Ming Xu; Xiaoxiao Gai; Chenghu Liu

doi:10.2131/jts.46.223

Original Article

Dose- and time-dependent systemic adverse reactions of sodium carboxy methyl cellulose after intraperitoneal application in rats

Chunguang Fan, Li Hou, Guoxi Che, Yanping Shi, Xiangdong Liu, Likui Sun, Wensi Jia, Fuyu Zhu, Zenglin Zhao, Ming Xu, Xiaoxiao Gai, Chenghu Liu

Author information

Chunguang Fan
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Li Hou
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Guoxi Che
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Yanping Shi
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Xiangdong Liu
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Likui Sun
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Wensi Jia
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Fuyu Zhu
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Zenglin Zhao
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Ming Xu
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Xiaoxiao Gai
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China
Chenghu Liu
Shandong Key Laboratory of Biological Evaluation for Medical Devices, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging, Shandong Quality Inspection Center for Medical Devices, China

Keywords: Sodium carboxy methyl cellulose, Adverse effects, Intraperitoneal application, Systemic toxicity study, Dose- and time-dependent effects, Absorbable biomaterials

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2021 Volume 46 Issue 5 Pages 223-234

DOI https://doi.org/10.2131/jts.46.223

Details

Abstract

Sodium carboxy methyl cellulose (SCMC) is an important absorbable biomaterial for anti-adhesion and hemostasis medical devices used in the abdominal cavity. However, the systemic toxicity of SCMC following intraperitoneal route has not been revealed sufficiently. Three SCMC solutions with gradient concentrations were intraperitoneally injected into 3 groups of rats with the doses of 50 mg/kg, 320 mg/kg and 2000 mg/kg respectively all at once to observe the dose-dependence of systemic reactions of SCMC and 10 rats (5 rats per sex) of each group were sacrificed 3 days, 7 days, 28 days and 90 days after injection to evaluate the time-dependence of the reactions. A range of adverse effects were shown in rats of the high-dose group which were found varied with time extending and virtually disappeared 90 days after injection. Slight reactions were observed in the medium-dose group while negligible effects were found in the low-dose group. The intraperitoneal application of SCMC can induce reversible systemic adverse effects to rats at the dose higher than 320 mg/kg and it is essential to take both dose- and time-dependent effects into account while designing a systemic toxicity study for absorbable biomaterials.

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