The pyrogen test is an important index of quality management relating to druggery injection and instillation and the current common methods are domestic rabbit test and Bacterial Endotoxins Test. Since there are short...The pyrogen test is an important index of quality management relating to druggery injection and instillation and the current common methods are domestic rabbit test and Bacterial Endotoxins Test. Since there are shortcomings and limitations of resources in these two methods , it’s necessary to look for another new substitute. We have done the preliminary study of the feasibility of the pyrogen test with domestic rabbit’s blood plasm, human’s plasm and THP 1. The principle is as follows: after incubating the standard sample of bacterial endotoxins, glycogen anti coagulation whole blood extracting from the healthy domestic rabbit, extralin anti congealable whole blood from healthy volunteers, THP 1 cells together, measure the releasing amount of TNF and IL 6 from cell gene by the method of ELISA as a endogenesis index judging the pro heat role of endotoxin. The results indicate: the blood rabbit’s whole blood, human’s whole blood, or THP 1cell, their releasing amount of TNF and IL 6 are closely connected with the amount of acting endotoxins within a certain range. Three methods have their own peculiarities and some feasibilities as a new substitute method for pyrogen test with domestic rabbit.展开更多
目的考察脱细胞粘膜基质的热原试验方法的可行性。方法依据《中华人民共和国药典》2010年版二部附录XIE细菌内毒素检查法和ISO10993.12 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials...目的考察脱细胞粘膜基质的热原试验方法的可行性。方法依据《中华人民共和国药典》2010年版二部附录XIE细菌内毒素检查法和ISO10993.12 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials,使用离心法消除样品浸提液的悬浮颗粒,使用动态浊度法验证离心条件是否会影响浸提液中细菌内毒素的检测。依据《中华人民共和国药典》2010年版三部附录XIID热原检查法检测脱细胞粘膜基质的热原试验是否合格。结果本实验中采用的离心条件不会影响样品浸提液中细菌内毒素的检测,热原试验合格。结论该产品可以采用此离心条件进行热原检测。展开更多
文摘The pyrogen test is an important index of quality management relating to druggery injection and instillation and the current common methods are domestic rabbit test and Bacterial Endotoxins Test. Since there are shortcomings and limitations of resources in these two methods , it’s necessary to look for another new substitute. We have done the preliminary study of the feasibility of the pyrogen test with domestic rabbit’s blood plasm, human’s plasm and THP 1. The principle is as follows: after incubating the standard sample of bacterial endotoxins, glycogen anti coagulation whole blood extracting from the healthy domestic rabbit, extralin anti congealable whole blood from healthy volunteers, THP 1 cells together, measure the releasing amount of TNF and IL 6 from cell gene by the method of ELISA as a endogenesis index judging the pro heat role of endotoxin. The results indicate: the blood rabbit’s whole blood, human’s whole blood, or THP 1cell, their releasing amount of TNF and IL 6 are closely connected with the amount of acting endotoxins within a certain range. Three methods have their own peculiarities and some feasibilities as a new substitute method for pyrogen test with domestic rabbit.
文摘目的考察脱细胞粘膜基质的热原试验方法的可行性。方法依据《中华人民共和国药典》2010年版二部附录XIE细菌内毒素检查法和ISO10993.12 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials,使用离心法消除样品浸提液的悬浮颗粒,使用动态浊度法验证离心条件是否会影响浸提液中细菌内毒素的检测。依据《中华人民共和国药典》2010年版三部附录XIID热原检查法检测脱细胞粘膜基质的热原试验是否合格。结果本实验中采用的离心条件不会影响样品浸提液中细菌内毒素的检测,热原试验合格。结论该产品可以采用此离心条件进行热原检测。
