Safety Monitoring

Bacterial endotoxin test of medical collagen implant

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  • 1. Beijing Forestry Univercity, Beijing 100083, China;
    2. National Institutes for Food and Drug Control, Beijing 102629, China

Received date: 2021-05-15

  Online published: 2024-06-24

Abstract

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.

Cite this article

LU Zhu-er, CHEN Dan-dan, CAI Tong . Bacterial endotoxin test of medical collagen implant[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(2) : 342 -345 . DOI: 10.16155/j.0254-1793.2022.02.20

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