Lightbown J W, Kogut M, Mussett M V
Bull World Health Organ. 1965;33(2):227-33.
At the request of the WHO Expert Committee on Biological Standardization a batch of oleandomycin was submitted to an international collaborative study in six laboratories situated in four countries. In this study the material was assayed by plate diffusion methods, which varied in details of technique and design, against the US Food and Drug Administration's reference preparation for oleandomycin. On the basis of the results obtained the material has been established as the International Standard for Oleandomycin and the International Unit of Oleandomycin is defined as the activity in 0.001176 mg of the International Standard. The US Food and Drug Administration's standard and the International Standard are each part of the same parent batch of oleandomycin and the validity of such an assay has been compared with the more usual assay situation when there is some degree of difference between the preparations under comparison.
应世界卫生组织生物标准化专家委员会的要求,一批竹桃霉素被提交至位于四个国家的六个实验室进行国际合作研究。在这项研究中,采用平板扩散法对该物质进行测定,这些方法在技术和设计细节上有所不同,以对抗美国食品药品监督管理局的竹桃霉素参考制剂。根据所获得的结果,该物质已被确立为竹桃霉素国际标准品,且竹桃霉素国际单位被定义为0.001176毫克国际标准品中的活性。美国食品药品监督管理局的标准品和国际标准品均为同一批母本竹桃霉素的一部分,并且已将这种测定方法的有效性与比较制剂之间存在一定程度差异时更为常见的测定情况进行了比较。