摘要
本文从抗生素标准品效价单位的定义着手 ,系统地阐述了抗生素标准品的确定原则。首批制备时应综合考虑溯源性、同质性、连续性和稳定性问题 ,而以后的制备则应采用协作标定的方法来保证标准品的连续性。并举例说明了首批抗生素标准品的制备过程。
The principle for determination of biological reference standards of antibiotics is discussed according to the definition of unit for antibiotic biological reference standards. The fountainhead,homogeneity,continuity,and stability should be considered for the original reference standard, whereas the continuity should be mainly pained attention on for successive preparation. Usually co-calibration should be selected according to a statistical method. Some examples for determination of the original biological reference standards are reviewed.
出处
《中国药事》
CAS
2001年第4期263-266,共4页
Chinese Pharmaceutical Affairs
关键词
抗生素
生物标准品
确定
antibiotics
biological reference standard
