辅酶Q_(10)注射液细菌内毒素检查方法的研究

根据中国药典2010年版二部附录细菌内毒素检查法要求,建立辅酶Q_(10)注射液的细菌内毒素检查方法,并进行方法学验证。结果表明,辅酶Q_(10)注射液原液对细菌内毒素凝集反应无干扰,其细菌内毒素限值符合规定。用本法检查辅酶Q_(10)注射液细菌内毒素是可行的。

Study on Bacterial Endotoxin Test for Coenzyme Q10 Injection

Bacterial endotoxin test method of coenzyme Q10 injection was established according to the requirement of Bacterial Endotoxin Test in the Appendix of the Chinese Pharmacopoeia 2010, and the method validation was carried out. The results showed that the coenzyme Q10 solution had no interference with the bacterial endotoxin agglutination reaction, and the bacterial endotoxin limit was in accordance with the regulation. Using this method to check coenzyme Q10 bacterial endotoxin injection is feasible.