吸附精制破伤风类毒素几种效力检定方法的比较

Comparison of Various Potency test Methods on Adsorbed purified Tetanus Toxoid

本文提供了用三种效力试验方法检定吸附精制破伤风类毒素的结果。WHO推荐的方法准确性高,但耗用动物过多。中国规程法没有要求用标准品作对照,因此对检品检定的结果,易受季节和动物饲养条件的影响。当前较为合理又简便易行的精破类检定方法是将待检品与标准品同时免疫动物,然后测定其血清抗毒素效价,如待检品的滴度等于或高于标准品即可认为合格。

This article presents the results of standardization of adsorbed purified tetanus toxoid by 3 potency test methods.The method recommended by WHO is admirable in accuracy, but it consumes much laboratory animals. There is no requirements in Chinese Regulation to set up a control group with a corresponding standard vaccine. Thus when the experimental group proceeds alone without a control, the results are usually affected by seasonal and animal feeding conditions. For the time being, the standardization of tetanus toxoid by a method easy to perform and comparatively rational is to immunize animals with the product to be identified and the referencing vaccine simultaneously, and then the titres of antitoxin are tested. If the antitoxic titre in the experimental serum equals or exceeds to that in the control group then the product is up to standard.