论文部分内容阅读
目的:建立快速的参芪扶正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参芪扶正注射液分别进行干扰试验,考察确立参芪扶正注射液内毒素检查法。结果:将参芪扶正注射液稀释2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参芪扶正注射液热原检查是可行的。
OBJECTIVE: To establish a rapid bacterial endotoxin test for Shenqi Fuzheng injection instead of pyrogen test. Methods: Interfering test was performed on Shenqi Fuzheng injection of different lot sizes by using specific limulus reagent and nonspecific limulus reagent. The endotoxin test of Shenqi Fuzheng injection was established. Results: The Shenqi Fuzheng injection was diluted more than 2 times, with the specificity of 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 Shenqi Fuzheng injection.