医用胶原蛋白海绵的细菌内毒素检测方法探讨  

Studies on Bacterial Endotoxin Detection Method for Medical Collagen Sponge

作　　者：朱丽丽[1] 陈思彬 李娜 马金竹[1] 董双鹏[1] ZHU Li-li;CHEN Si-bin;LI Na;MA Jin-zhu;DONG Shuang-peng(Tianjin Medical Devices Supervision and Testing Center,Tianjin 300384)

机构地区：[1]天津市医疗器械质量监督检验中心,天津300384

出　　处：《中国医疗器械信息》2024年第13期26-28,85,共4页China Medical Device Information

摘　　要：目的:通过不同的方法测定胶原蛋白海绵的细菌内毒素含量,旨在为这类产品的内毒素检测提供一种准确可靠的检测方法,为生产企业提供技术支持。方法:采用细菌内毒素凝胶限量试验,半定量试验和定量试验测定医用胶原蛋白海绵的内毒素含量。结果:凝胶限量试验结果显示,供试品细菌内毒素含量不超过20EU/件;凝胶半定量试验结果显示该供试品细菌内毒素含量不超过4.8EU/件;浊度法试验结果显示,该供试品原液的内毒素回收率为58%,当细菌内毒素试验的回收率50%~200%,试验有效,该供试品细菌内毒素含量为8.216EU/件,50%稀释液的内毒素回收率为98%,该供试品细菌内毒素含量为5.032EU/件。结论:内毒素凝胶限量试验方法简单可靠,可满足企业日常的质量控制,半定量法是通过对样品不同稀释度的内毒素检测,可提供产品较为准确的内毒素含量数据,定量法虽可准确测出产品内毒素的含量,但该方法复杂,且影响因素较多,通过排除干扰,可采用此法对产品中的内毒素含量进行定量。Objective:Different methods were used to detect the bacterial endotoxin content of medical collagen sponge,the purpose is to provide an accurate and reliable method of endotoxin detection for such products and to provide technical support for manufacturing enterprises.Methods:Gel-clot limit test,semi quantitative test and quantitative test were conducted separately for detecting or quantifying endotoxins of medical collagen sponge.Results:Gel-clot limit test showed that bacterial endotoxin of the test article did not exceed 20EU/piece;The semi quantitative test showed that bacterial endotoxin of the test article did not exceed 4.8EU/piece;The quantitative test showed that the bacterial endotoxin recovery of the original solution(100%extracts)was 58%,the test was valid(endotoxin recovery was from 50%to 200%),the bacterial endotoxin of the test article was 8.216 EU/piece,the endotoxin recovery of 50%extracts was 98%,and the bacterial endotoxin of the test article was 5.032 EU/piece.Conclusion:Gel-clot limit test is simple and reliable,which can meet the daily quality control of medical collagen sponge for manufacturing enterprises.The semi quantitative method can provide more accurate endotoxin concentration through detecting endotoxin of different dilutions compared to gel-clot limit test.The quantitative method can provide specific value of endotoxin concentration for test article.This method is complex and it is easily influenced by many factors.By eliminating interferences,manufacturing enterprises can use this method to quantify the endotoxin content of products.

关 键 词：胶原蛋白海绵 凝胶限量法 半定量试验 定量试验 细菌内毒素 

分 类 号：R318.08[医药卫生—生物医学工程]