庆大霉素组分和有关物质对效价的影响

摘要

目的 对庆大霉素组分和有关物质与效价的关系加以探讨研究,说明浊度法测定效价较管碟法测定效价的高灵敏度与高选择性,以及控制庆大霉素组分和有关物质的必要性.方法 浊度法和管碟法:中国药典2005年版二部.HPLC法:色谱柱为Venusil ASB C18(4.6mm×25cm,5μm);流动相为0.2mol/L三氟乙酸溶液-甲醇(96:4),流速为0.6mL/min,蒸发光散射检测器漂移管温度为110℃,载气(氮气)流速为2.8L/min,柱温为35℃；进样量为20μL.结果 浊度法更好地反映了庆大霉素组分和有关物质的变化；不同企业庆大霉素制剂的组分和有关物质差异较大.结论 浊度法较管碟法对组分和有关物质变化的反应灵敏度高、选择性好,更好地反应了样品的实际质量；应对庆大霉素的组分比例和有关物质严格控制,以确保药品的安全、有效.%Objective To study the effection of the component and the related impurities of gentamicin to the content of microbial potency, thus to reveal the better selection of turbidimetric assay than the cylinder-plate assay. Methods The turbidimetric assay and the cylinder-plate assay: Chinese Pharmacopeia 2005 Vol 2. HPLC method. The analytical column was Venusil ASB C18 (4.6mmx25cm, 5μm). The column temperature was 35℃. The mobilephase was consisted of the 0.2mol/L trifluoroacetic acid solution-methanol(96:4): The flow rate was 0.6mL/min, the drift tube temperature of Alltech 2000 was 110℃, the pressure of nebulizing gas was 2.8L/min, the inject volume was 20μL. Results The result of the turbidimetric assay reflect the change of the gentamicin component and the impurities bettly. Conclusion The turbidimetric assay was more specific than the cylinder -plate assay to reflect the actual change of the gentamicin component. The component and the related impurities of gentamicin should be controlled strictly to ensure the safety and the efficacy of gentamicin.