注射用头孢他啶的毒性及致敏性研究

Study on the toxicity and anaphylaxis of Ceftazidime for injection

目的研究导致注射用头孢他啶毒性及致敏性的原因。方法使用影响因素试验样品进行小鼠和豚鼠的毒性及豚鼠的致敏性实验,对其中具有毒性和/或致敏性的样品,通过比较其溶液颜色和浊度的变化和用HPLC法分别测定样品处理前后吡啶、聚合物和杂质的变化,来探讨头孢他啶毒性和致敏性的来源。结果贮存温度的升高可降低头孢他啶的溶解性、增加样品中的杂质,导致致敏性或毒性的产生。注射用头孢他啶的致敏性与样品中的不溶性物质或杂质有关,毒性与样品降解产生的杂质A、G、F和杂质11、13有关,这些杂质也可能是致敏的原因之一。结论严格控制注射用头孢他啶的贮存温度,降低其毒性和致敏性,保证用药安全。

OBJECTIVE To investigate Cefiazidime for injection to figure out the cause of the toxicity and anaphylaxis. METHODS The sample of Ceftazidime for injection was placed under the condition of influence factor test, in which the samples with toxicity and/or anaphylaxis was picked out to determine the change of color and turbidity of the solution and the level of pyridine, polymers and impurities pre - and post - treatment by HPLC method separately. RESULTS Temperature increment could decrease sample＇ s solu- bility and increase the levels of impurities, which caused toxicity and anaphylaxis. The anaphylaxis of Ceftazidime for injection comes from insoluble substance or impurities during temperature increment; the toxicity was related to degradation impurities A, G, F, 11 and 13, which might be related to anaphylaxis also. CONCLUSION The storage temperature of Cefiazidime for injection should be strictly controlled, which helped to reduce toxicity and anaphylaxis, and ensure the safety of drug use.