北京生物医学工程

羧甲基化棉短绒止血纱布的生物相容性研究

Biocompatibility ofcarboxymethylated cotton linters hemostatic gauze

作者：柳小军刘康博刘振师月周静徐玉茵王海涛田源

单位：河南省医疗器械检验所（国家药监局医用生物防护及植入器械质量评价重点实验室）（郑州  450003）;南阳市久康医疗器械有限公司（河南南阳473125） <p>通讯作者：王海涛，正高级工程师，E-mail:876239798@qq.com</p>

关键词：止血纱布；羧甲基化棉短绒；毒性反应；凝血；生物相容性

分类号：R318. 08

出版年·卷·期（页码）：2022·41·5（500-505）

摘要：

目的研究羧甲基化棉短绒止血纱布的生物相容性，评价其生物安全性。方法进行皮内反应试验、皮肤致敏试验、急性全身毒性试验、溶血试验、体外凝血指标试验和体外血栓形成试验，通过检测皮内反应记分、皮肤致敏反应等级、毒性反应、溶血率、体外凝血指标和纤维蛋白原含量等指标分析羧甲基化棉短绒止血纱布的生物相容性。结果羧甲基化棉短绒止血纱布无潜在的动物皮内刺激作用、无皮肤致敏性和无急性全身毒性反应；溶血率符合要求；实验组纱布在凝血试验中凝血酶原时间（prothrombin time，PT)和活化部分凝血活酶时间（activated partial thromboplastin time，APTT)与体外血栓形成试验中纤维蛋白原含量虽与对照组相比有显著性差异（P＜0.05），但与对照组的相对百分比均在85%～115%之间。结论羧甲基化棉短绒止血纱布具有良好的生物相容性，符合国家相关标准要求，为其在临床创面止血中的安全应用提供参考。

Objective To evaluate the biological safety of carboxymethylated cotton linters hemostatic gauze by studying its biocompatibility. MethodsIntradermal reaction test, skin sensitization test，acute systemic toxicity test, hemolysis test, blood coagulation index test and thrombosis test in vitro were examined andthe biocompatibility of carboxymethylated cotton linter hemostatic gauze was analyzed by intradermal rank score, skin sensitization reaction degree and toxicity reaction, hemolysis rate, in vitro coagulation indexes and fibrinogen content. Results The carboxymethylated cotton linters hemostatic gauze had no potential indermal irritation, no skin sensitization and no acute systemic toxicityandthe hemolysis rate met the requirements. There were significant difference about prothrombin time (PT) and activated partial thromboplastin time (APTT) in the coagulation test and the fibrinogen contentin vitro thrombosis test between experimental and control group(P<0.05), but the relative percentages ofexperimental group was between 85% and 115% compared with the control group. Conclusion The carboxymethylated cotton lintershemostatic gauze in this study has good biocompatibility and conforms to relevant national standards, which provides reference for its safe application in clinical wound hemostasis.

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