摘要
目的确定盐酸万古霉素欧洲药典(EP)方法对美国药典(USP)方法生物效价测定结果的校正系数。方法取盐酸万古霉素工作标准品和30批样品分别采用EP和USP两种微生物检定方法进行效价测定;取盐酸万古霉素USP标准品采用EP微生物检定方法进行效价测定。结果 EP生物效价对USP生物效价测定结果的校正系数为1.072。结论校正系数的确定,有利于EP生物效价与USP生物效价之间的相互转换。
Objective To determine the correction factor of microbiological assay between European Pharmacopoeia （EP） method and United States Pharmacopoeia （USP） method for vancomycin hydrochloride. Methods To perform microbiological assay test for vancomycin hydrocloride reference standard and 30 batches of samples by using EP method and USP method to perform microbiological assay test for vancomycin hydrocloride USP reference standard by using EP method. Results The correction factor of EP method to USP method is 1.072. Conclusion The correction factor determination of microbiological assay is convenient for conversion between EP method and USP method.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2011年第12期926-928,共3页
Chinese Journal of Antibiotics
关键词
生物效价
EP方法
USP方法
校正系数
Microbiological Assay
EP Method
USP Method
Correction factor
