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早在1947年WHO专家委员会就提出建立白喉类毒素国际标准品,以用于白喉类毒素的效力检定,经过长期的准备,在1951年建立了液体白喉类毒素国际标准品。1955年又建立了吸附白喉类毒素国际标准品。我国对白喉类毒素的效力检定,一直采用最低要求法,不需要标准品做对照。1977年WHO制订的白喉类毒素规程,在效力试验中提出应该有标准类毒素做为对照。为此,我们於1984年制备了吸附白喉类毒素的参考品,用国际标准进行标化,卫生部北京生物制品研究所参加协作标定,并送日本国立卫生研究所进行复核。现介绍如下:
As early as 1947, the WHO Expert Committee proposed the establishment of an international standard for diphtheria toxoid to test the efficacy of diphtheria toxoid. After a long period of preparation, an international standard for diphtheria toxoid was established in 1951. In 1955 and the establishment of an international standard diphtheria toxoid adsorption. Diphtheria toxoid efficacy test in our country, has been using the minimum requirements of law, do not need standard control. The diphtheria toxoid regulations developed by the WHO in 1977 proposed in the efficacy trials that a standard toxoid should be used as a control. To this end, we prepared a reference substance for diphtheria toxoid adsorption in 1984, which was standardized by international standards. The Beijing Institute of Biological Products of the Ministry of Health participated in the collaborative calibration and sent to Japan’s National Institute of Health for review. Now introduced as follows: