三磷酸腺苷二钠注射液细菌内毒素检查法的初步实验研究

目的建立三磷酸腺苷二钠注射液细菌内毒素检查法。方法按《中国药典》2005年版（二部）附录收载的细菌内毒素检查方法进行实验。结果在3．33mg·mL^-1稀释浓度时对细菌内毒素检查法无干扰作用。用细菌内毒素检查法检查三磷酸腺苷二钠注射液的细菌内毒素是可行的。结论可以用细菌内毒素检查法代替家兔法来控制三磷酸腺苷二钠注射液的质量。

Study on bacterial endotoxin foundational preliminary test of adenosine disodium triphophate injection

OBJECTIVE To establish a method of bacterial endotoxin test of adenosine disodium triphophate injection.METHODS The test was conducted according to bacterial endotoxin test method XIE] in the appendix Ⅱ of china Pharmaciopeia 2005. RESULTS 3.33mg· mL^- 1 solution of adenosine disodium triphophate injection don＇ t inhibit or enhance the test, it is feasible to detect the bacterial endotoxin of adenosine disodium triphophate injection by the method of eterrnination of bacterial endotoxin. CONCLUSION Bacterial endotoxin test can be used in place of rabbit method for pyrogen monitoring of adenosine disodium triphophate injection.