庆大霉素组分差异对效价测定可靠性测验的影响

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》2015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C2+C2a相对百分含量差异超过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。

Influence of the differences of gentamicin components on the reliability test of the potency determination#br#

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 requirements when relative percentage differences of C2+C2a between the gentamicin test sample and the standard is more than 4%. Conclusion Attention should be paid to the effects of the differences of components in multicomponent antibiotics on the accuracy of the potency determination, and the allowable content range of components in the corresponding quality standard should be further