液体制剂中利奈唑胺注射液和ω-3鱼油脂肪乳的分析-analysis of linezolid injection and omega - 3 fish oil fat emulsion in liquid preparation.docxVIP

摘要处方量的蛋黄卵磷脂、甘油、油酸钠加入适量水中，在 70℃水浴加热磁力搅拌20min，此为水相；鱼油和维生素 E 为油相；将油相缓慢滴加到水相中，14000rpm 转速下剪切 10min，用氢氧化钠溶液调节 pH 值至 8.5 左右，定容至处方量。将 初乳转移至微射流均质机中，压力为 18k，高压均质 10 次，121℃灭菌 15min。（2）ω-3 鱼油脂肪乳剂的质量评价。制剂的外观为白色均一乳状液体，平 均粒径为 206.5nm，PDI 为 0.210，Zeta 电位是-37.2mv，pH 值在 7.5-8.3 之间， 游离脂肪酸符合规定。（3）ω-3 鱼油脂肪乳剂的稳定性研究。进行冻融试验，结果表明该制剂应 避免冷冻。影响因素和加速试验中，高温会对脂肪乳质量造成一定的破坏。经 过 6 个月的长期留样试验，稳定性良好。关键词：利奈唑胺 注射液 ω-3 鱼油 脂肪乳 制备 稳定性IIAbstractLiquid preparations refer to drugs disperse in the liquid medium,classified into two kinds,one is homogeneous system,another is heterogeneous system.Injections belong to typical and homogeneous liquid preparation,which require the safety and effectiveness on the clinical application.The quality of liquid preparation can be controlled.Linezolid is the first synthesized drug of oxazolidinone.It has unique antibacterial mechanism.This article discusses the preparation and optimization of prescription,requirement of quality and stable test,specific contents as follows:Prefomulation studies of linezolid injection.To determine some parameters such as pH,osmotic pressure,and establish HPLC method for determining the linezolid content.The method has good specificity,linear relation in the 20-150 μg/ml concertration is well.The recoveries are between 98.0% to 102.0%.The results of precise and solution stable tests are well.The method of determining related substances,which uses the gradient elution program.In the oxidative damage test, linezolid produces oxide-material.There is degradated impurity in acid and alkali damage experiment.Linezolid injection doesn’t produce any impurity,under the condition of high temperature and strong light.Therefore,it’s crucial that control the quality of linezolid injectin.Through the method,the concentrations of dection limit and quantitation limit are 0.193μg/ml,0.379μg/ml respectively.Preparation studies of linezolid injection.To investigate the single factor, such as,the dosage of isotonic regulator and buffer salt,the range of pH.Then, d