庆大霉素组分差异对效价测定可靠性测验的影响.pdf

中国抗生素杂志2018年2月第43卷第2期 . 211 . 文章编号：1001-8689(2018)02-0211-05 庆大霉素组分差异对效价测定可靠性测验的影响 韩宁宁 戴青 于丽娜 王静文 徐嫄 赵晖* ( 中国兽医药品监察所，北京100081) 摘要：目的 对庆大霉素组分差异与效价测定可靠性测验的关系进行探究，以期得到导致可靠性测验不符合规定的组分差 异限值。方法 按照 《中国药典》2015版二部庆大霉素品种下庆大霉素C组分检查项的液相色谱-蒸发光散射检查法进行组分含 量测定，按照 《中国药典》20 15版四部微生物检定法进行管碟法与浊度法的测定。结果 庆大霉素供试品与标准品C +C 相对 2 2a 百分含量差异超过4%时，即会导致三剂量法可靠性测验不符合规定。结论 应关注多组分抗生素组分差异对效价测定准确性的 影响，并在相应质量标准中对允许的组分含量范围进行进一步细化。 关键词：庆大霉素；C组分相对百分含量的差异；效价；可靠性测验 中图分类号：R978.1 文献标志码：A Influence of the differences of gentamicin components on the reliability test of the potency determination Han Ning-ning, Dai Qing, Yu Li-na, Wang Jing-wen, Xu Yuan and Zhao Hui (China Institute of Veterinary Drug Control, Beijing 100081) Abstract Objective To explore the relationship between the differences of gentamicin components and the reliability test of the potency determination and to further get the limited value of the differences of components which would lead to the inconformity of the reliability test. Methods The content of the components was determined by the method of liquid chromatography-evaporative light scattering detection according to the gentamicin C components of gentamicinin Chinese Pharmacopoeia (Vol II, 2015). The potency was determined by the cylinder plate method and the turbidimetric method according to the microbiological assay in Chinese Pharmacopoeia (Vol IV, 2015). Results The reliability test of the three-dose method could not meet the requiremen