Studies on Bacterial Endotoxin Detection Method for Medical Collagen Sponge
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.
medical collagen spongegel-clot limit testsemi quantitative testquantitative testbacterial endotoxin
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