A型产气荚膜梭菌滤液的质控标准研究

Study on Quality Control Standard for Clostridium perfringens Type A Culture Filtrate Preparation

制备鸡传染性支气管炎病毒(IBV)血凝抑制试验抗原需用到A型产气荚膜梭菌滤液,拟建立A型产气荚膜梭菌滤液的质控标准。对29批A型产气荚膜梭菌滤液进行小鼠致死性、卵磷脂酶活性、处理IBV后其血液凝集活性和滤液最小加入量试验。结果显示,不同批滤液的小鼠最小致死量(MLD)及卵磷脂酶效价之间存在较大差异,但两者之间存在正相关关系,而这两者与处理后IBV的HA活性没有明显的相关关系。试验证明以小鼠最小致死量或卵磷脂酶效价作为滤液质控标准不可行,而以处理后IBV的HA活性作为滤液的质控方法,该方法简单可靠,可直接反映滤液使IBV产生血凝活性的能力。

To establish the quality control standard for production of type A Clostridium perfringens cul ture filtrates used in IB HI antigen preparation. 29 batches of the culture filtrate were tested for their le thality in mice, their lecithinase activity, the HA activity of the treated IBV and the minimum filtrate vol ume needed for IB HI antigen preparation. The results showed that the minimum lethal dosage in mice and the lecithinase titers differed significantly between the batches, demonstrates that the minimum lethal dos age in mice has positive correlation with the lecithinase titers, whereas the two have little correlation with the HA activity of the filtrate treated IBV antigens. It proves that taking the minimum lethal dosage in mice or the leeithinase titer as the quality control standard for production of type A C. perfringens culture filtrate is infeasible, based on the experiment results, HA activity test of the filtrate treated IBV antigens was chosen as the quality control method, which is a simple test and directly reflects the HA activity of the IBV antigen after treatment with the C. perfringens type A filtrate.