医用胶原充填剂的细菌内毒素检测  

Bacterial endotoxin test of medical collagen implant

作　　者：陆珠儿 陈丹丹[2] 蔡彤[2] LU Zhu-er;CHEN Dan-dan;CAI Tong(Beijing Forestry Univercity,Beijing 100083,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]北京林业大学,北京100083 [2]中国食品药品检定研究院,北京102629

出　　处：《药物分析杂志》2022年第2期342-345,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立医用胶原充填剂的细菌内毒素检测方法。方法:分别采用ISO10993.12的样品制备方法(浸提液法)和盐酸溶解法,对医用胶原充填剂进行前处理,然后采用2020年版《中华人民共和国药典》(简称《中国药典》)四部通用技术要求(通则)1143细菌内毒素检查法中的动态浊度法进行细菌内毒素含量的检测。结果:浸提液法制备的供试液细菌内毒素含量(0.12EU·mL^(-1)),远低于使用0.01 mol·L^(-1)盐酸溶解法制备的供试液细菌内毒素含量(9.991EU·mL-1)。结论:不同的样品制备方法会影响检测医用胶原充填剂中细菌内毒素含量的准确性。故采用使用0.01 mol·L^(-1)盐酸溶解法制备医用胶原充填剂的供试液,这样可充分地把供试品中的细菌内毒素释放出来,之后再进行细菌内毒素检测较为合适。Objective:To establish a bacterial test for the determination of bacterial endotoxin in medical collagen fillers.Methods:The bacterial endotoxin concentration of medical collagen fillers was determined by the method of extraction according to the bacterial endotoxin kinetic chromogenic assay method in the Chinese pharmacopoeia 2020 edition and ISO10993.12 biological evaluation of medical devices Part 12:sample preparation and reference materials.In addition,the bacterial endotoxin content in the samples was detected by kinetic chromogenic assay with 0.01 mol·L^(-1) hydrochloric acid dissolving medical collagen filling agent.Results:The bacterial endotoxin content of the test solution prepared by the extraction method was 0.12 EU·mL^(-1),and the bacterial endotoxin content of the test solution prepared by hydrochloric acid dissolution was 9.991 EU·mL^(-1).Different methods of sample preparation will detect different bacterial endotoxin content in the same sample.Conclusion:Different methods of sample preparation can affect the accuracy of bacterial endotoxin content in medical collagen filling agent.The bacterial endotoxin in the test sample can be fully released by 0.01 mol·L^(-1) hydrochloric acid solution.The bacterial endotoxin test of the test solution of medical collagen filling agent by hydrochloric acid dissolution is more strict and accurate.

关 键 词：胶原 细菌内毒素 盐酸 动态显色法 浸提 

分 类 号：R917[医药卫生—药物分析学]