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目的建立快速的乙酰谷酰胺注射液细菌内毒素检查法,替代热原检查法。方法用特异性鲎试剂和非特异性鲎试剂对不同批号的乙酰谷酰胺注射液分别进行干扰试验,考察确立乙酰谷酰胺注射液内毒素检查法。结果将乙酰谷酰胺注射液稀释50倍以上,用特异性鲎试剂可消除干扰作用,结果准确可靠。结论利用特异性鲎试剂进行细菌内毒素检查代替乙酰谷酰胺注射液热原检查是可行的。
Objective To establish a rapid bacterial endotoxin test for acetylglutamine injection instead of pyrogen test. Methods Interfering tests were performed on different batches of acetylated glutamine injection by using specific 鲎 reagents and nonspecific 鲎 reagents respectively. The endotoxin test for acetylglutamine injection was established. Results Acetyl glutamine injection diluted more than 50 times, with specific 鲎 reagent can eliminate the interference effect, the result is accurate and reliable. CONCLUSION: It is feasible to use pyrogen reagent to carry out bacterial endotoxin test instead of pyrogen test of acetyl glutamide injection.