【作者】 周华萍；

【导师】 单伟光；

【作者基本信息】 浙江工业大学 ， 制药工程， 2007， 硕士

【摘要】 硫酸西索米星为新一代的氨基糖苷类抗生素,在临床上的运用广泛,因为它不仅弥补了传统氨基糖苷类抗生素的不足,而且较于传统氨基糖苷类抗生素,它的抗菌谱更加广泛。硫酸西索米星制剂产品的广泛使用无疑对其检测方法特别是有效成分的测定方法提出了更高的要求。目前本单位所依据的检测方法为微生物检定法,但是此方法存在很多缺陷,比如数据重复性较差、检验环境要求比较苛刻以及检验过程比较冗长等。所以本文在现有检测方法与各种研究资料的基础上,建立了以示差折光检测器-高效液相法来检测硫酸西索米星及注射剂中硫酸西索米星的含量。其中色谱柱采用C₁₈柱（4.6×250mm,5μm）,流动相为0.02mol/1三氟醋酸:甲醇（95:5）,流速为1.0ml/min,柱温为35℃。同时本文对所建立的方法进行方法学验证,对于硫酸西索米星原料,回收率为99.3%,硫酸西索米星注射液回收率为99.4%。该方法在浓度为0.1mg/m1-2.5mg/ml之间线性回归方程为Y=261623X+6183,r=0.9995。通过方法学验证以及与现有检测方法的比较,结果表明所建立的方法简便、准确、专属性好,能满足质量控制与生产的要求并且避免了现有检测方法的诸多缺点。更多还原

【Abstract】 Sisomicin sulfate is a new generations of Aminoglycoside antibiotics, which is widely applied in clinical practice. It not only makes up deficiency of traditional Aminoglycoside antibiotics, but also has broad Antibacterial spectrum compared to traditional ones. It puts forward higher requirements of its analytical method, especially for the active component determination, because of the wide application of sisomicin sulfate formulations.The current analytical method is microbiological test in our company, and there are some deficiencies such as data repeatability being not good, high requirement for environment. The Differential refraction-HPLC detector method is established on current analytical method and relevant research literatures. Chromatographic column is C₁₈ column （4.6×250mm, 5μm）, mobile phase is a mixture of 0.02mol/l trifluoroacetic acid: methanol （95:5）, flow rate is 1.0ml/min and column temperature is 35℃. Moreover, methodological validation of the method is performed: the recovery is 99.3% for Sisomicin sulfate API, 99.4% for Sisomicin sulfate injection. The linearity equation is Y=261623X+6183, r=0.9995 for concentrations between 0.1 mg/ml and 2.5mg/ml.Through methodological validation and compared to current method, the established method is more convenient, accurate and specific, which is able to satisfy the requirements of quality control and production.更多还原