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Published on: March 10, 2015
Dose- and time-dependent systemic adverse reactions of sodium carboxy methyl cellulose after intraperitoneal
Chunguang Fan1, Li Hou1, Guoxi Che1
1Shandong 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.
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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