注射用盐酸丁咯地尔细菌内毒素检查法的研究

Study on the Test for Bacterial Endotoxin of Buflomedil Hydrochloride for Injection

研究注射用盐酸丁咯地尔对细菌内毒素检查试验的干扰情况 ,并建立其细菌内毒素检查的方法。按《中国药典》 2 0 0 0年版二部附录ⅪE细菌内毒素检查法和附录ⅪⅩF细菌内毒素检查法应用指导原则进行试验。本品在 0 33mg·ml-1稀释浓度下无干扰作用 ,L =1 5EU·mg-1。

According to the CP2000, inhibition or enhancement test for bacterial endotoxins test was done of buflomedil hydrochloride for injection. The results shown that 0.33mg·ml -1 solution of buflomedil hydrochloride for injection didnt inhibit or enhance the test, L=1.5EU·mg -1. A bacterial endotoxins test method was established and can be used for this specimnen to instead of pyrogen test.