摘要
目的建立高效亲和色谱（HPAC）法测定静注人免疫球蛋白中IgG的含量。方法用HiTrapProteinGHP亲和色谱柱，以0．05mol／L磷酸盐缓冲液和0．07mol／L的甘氨酸一盐酸盐缓冲液为流动相，流速为0．4ml／min，检测波长为280nm。结果IgG含量在0．25～2．0mg／ml浓度范围内与峰面积呈良好的线性关系（r=0．9999）；平均回收率为96．6％，相对标准偏差值（RSD）=2．3％（n=9）。结论本方法简便、快速、重现性好，可用于IgG的含量测定。
Objective To establish a high-performance affinity chromatography （HPAC） method for the content determination of IgG in human immunoglobulin for intravenous injection （IVIG）. Methods Chromatography was performed on HiTrap Protein G HP affinity column. The 0.05 mol/L PBS and 0.07 mol/L glycin-hydrochloric acid buffer solution was used as mobile phase. The flow rate was 0.4 ml/min. Detective wavelength was 280 nm. Results The calibration curves of IgG was linear within the range of 0.25-2.0 mg/ml. The average recovery was 96.6%, and RSD was 2.3% （n = 9）. Conclusion This method is simple, fast, and reproducible. It can be used for the content determination of IgG in IVIG.
出处
《今日药学》
CAS
2010年第4期31-33,共3页
Pharmacy Today
