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目的:研究细菌内毒素检查法在含抗凝剂的采血袋质量控制检查中应用的可行性。方法:根据中华人民共和国药典2000版二部收载的细菌内毒素检查法;参考美国药典23版(1995年)对含枸橼酸盐抗凝剂的细菌内毒素检查的质量标准。结果;样品稀释40倍可消除干扰;与家兔法结果一致。结论:细菌内毒素检查法可用于采血袋的质量控制。
Objective: To study the feasibility of bacterial endotoxin test in the quality control of anticoagulant-containing blood collection bags. Methods: The bacterial endotoxin test was carried according to the Pharmacopoeia 2000 of the People’s Republic of China, 2000; and the quality standard of bacterial endotoxin test of citrate anticoagulants with reference to the United States Pharmacopoeia 23 (1995). Results; Sample dilution of 40 times to eliminate interference; consistent with the results of the rabbit. Conclusion: Bacterial endotoxin test can be used for the quality control of blood collection bags.