LIGHTBOWN J W, KOGUT M, UEMURA K
Bull World Health Organ. 1963;29(1):87-94.
At the request of a WHO Expert Committee on Biological Standardization, a batch of nystatin, comparable in purity to material used therapeutically, was submitted to an international collaborative study in nine laboratories in six countries. In this study the material was assayed by the plate diffusion method (and in one laboratory also by a turbidimetric method) against the United States Pharmacopeia Reference Preparation of Nystatin. On the basis of the results obtained the material has been established as the International Standard for Nystatin, and the International Unit of Nystatin is defined as the activity in 0.000333 mg of the International Standard.
应世界卫生组织生物标准化专家委员会的要求,一批纯度与治疗用材料相当的制霉菌素被提交至六个国家的九个实验室进行国际协作研究。在这项研究中,采用平板扩散法(在一个实验室还采用了比浊法)将该材料与美国药典制霉菌素参考制剂进行测定。根据所获得的结果,该材料已被确立为制霉菌素国际标准品,制霉菌素国际单位被定义为0.000333毫克国际标准品中的活性。