Lacasa C, Vega F A
J Parenter Sci Technol. 1989 Sep-Oct;43(5):246-9.
Three pyrogen assay methods [the rabbit method, Limulus Amebocyte Lysate (LAL) gelation and chromogenic substrate, and bioburden prior to sterilization] were evaluated in three standard batches of small-volume parenteral preparations; i.e., water for injection, sodium chloride 0.9% injection, and sodium bicarbonate 8.4% injection. The same preparations were also assayed after contamination with Escherichia coli followed by sterilization. All methods gave the same results with the water for injection and the sodium chloride 0.9%. With sodium bicarbonate 8.4%, only the rabbit method was valid. For sodium chloride 0.9%, the chromogenic substrate method was valid; the gelation method was not valid. Endotoxins from the manufacturing plant were less pyrogenic in rabbits than were standard endotoxins or those from hospital E. coli.
在三批标准的小容量注射用制剂（即注射用水、0.9%氯化钠注射液和8.4%碳酸氢钠注射液）中评估了三种热原检测方法[家兔法、鲎试剂凝胶法和显色基质法以及灭菌前的生物负荷检测法]。同样的制剂在被大肠杆菌污染后再进行灭菌，然后也进行了检测。对于注射用水和0.9%氯化钠注射液，所有方法的检测结果相同。对于8.4%碳酸氢钠注射液，只有家兔法有效。对于0.9%氯化钠注射液，显色基质法有效；凝胶法无效。来自生产厂家的内毒素在家兔体内产生的热原反应比标准内毒素或医院来源的大肠杆菌产生的热原反应弱。
