本文選題：高效陰離子交換色譜-脈沖安培檢測法 + 多糖疫苗��； 參考：《中國新藥雜志》2014年15期

【摘要】：目的:建立Y群W135群腦膜炎球菌莢膜多糖含量的高效陰離子交換色譜-脈沖安培檢測法(high-performance anion-exchange chromatography with pulsed amperometric detection,HPAEC-PAD),并對該方法進行驗證。方法:通過對水解溫度、水解時間和水解用酸及其濃度的篩選,確定最佳的水解條件;利用固總法和化學(xué)法衡量HPAEC-PAD法的準確性,檢測ACYW135群腦膜炎球菌多糖疫苗和Y群W135群多糖蛋白結(jié)合疫苗原液,評價其重復(fù)性和精密性。結(jié)果:最佳水解條件為2mol·L-1 HCL 80℃水解1h。色譜法的檢測結(jié)果與固總法和化學(xué)法比較,CV在1.60%~5.04%,結(jié)果準確。檢測Y群和W135群多糖含量重復(fù)性和精密性均良好。結(jié)論:HPAEC-PAD法可以用于Y群W135群多糖含量的測定。
[Abstract]:Aim: to establish a high performance anion-exchange chromatography with pulsed amperometric detection method for high performance anion-exchange chromatography with pulsed amperometric detection of meningococcal meningococcal capsule polysaccharides (HPAEC-PADX) in group Y, and to verify the method.Methods: the optimum hydrolysis conditions were determined by screening hydrolysis temperature, hydrolysis time, hydrolysis acid and its concentration, and the accuracy of HPAEC-PAD method was measured by solid sum method and chemical method.ACYW135 meningococcal polysaccharide vaccine and Y group W135 polysaccharide protein binding vaccine were detected to evaluate their reproducibility and accuracy.Results: the optimum hydrolysis condition was 2mol L-1 HCL for 1 h at 80 鈩，

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