摘要
目的:探索红花、柴胡注射液进行细菌内毒素检查的可行性并建立方法。方法:依据《中国药典》2015年版四部通则中的细菌内毒素检查法进行试验,并将结果与家兔法进行比较。结果:红花注射液稀释至30倍(细菌内毒素限值为15EU·mL-1),柴胡注射液稀释至200倍(细菌内毒素限值为75 EU·mL-1)进行细菌内毒素检查是可行的。结论:红花、柴胡注射液均可用细菌内毒素检查法进行检验。
Objective:To explore and establish a test method for bacterial endotoxin of Safflower Injection and Bupleurum Injection.Methods:The test was performed as per bacterial endotoxin test in the Chinese Pharmacopoeia 2015 VolumeⅣ.The obtained results were compared with that of pyrogen rabbit test.Results:The interference was eliminated when Safflower Injection was diluted 30 times and Bupleurum Injection was diluted 200 times.The sensitivity of TAL was 0.125 EU·mL-1 and 0.25 EU·mL-1 respectively.Conclusion:The established methods can be applied to bacterial endotoxin test for Safflower Injection and Bupleurum Injection.
作者
王奕匀
马迎春
吕栋
贺军权
WANG Yiyun;MA Yingchun;L Dong;HE Junquan(Gansu Institute of Drug Control,Drug and Cosmetics Safety Evaluation Center,Lanzhou 730070,China)
出处
《中国药品标准》
CAS
2020年第4期355-359,共5页
Drug Standards of China
关键词
红花注射液
柴胡注射液
细菌内毒素
干扰试验
家兔法
Safflower Injection
Bupleurum Injection
bacterial endotoxin
interference tests
pyrogen rabbit method
