摘要
目的:采用分子排阻色谱法测定水解蛋白注射液中小分子肽的分子量。方法:采用TSK-GEL G2000SWXL色谱柱(7.8mm×300 mm,5μm),以磷酸盐缓冲液(pH 6.8)(含0.1 mol.L-1Na2SO4与0.05%NaN3)为流动相,流速1.0 mL·min-1,柱温30℃,检测波长280 nm。结果:水解蛋白注射液中分子量大于胰岛素的高分子物质含量均在5%以下。结论:该方法简单,重现性好,可以作为控制水解蛋白注射液中高分子物质的方法。
Objective： To establish a sige-exclusion chromatography method for determination of high polymer in protein hydrolysate in- jection. Methods： The separation was performed in a TSK-GEL G2000SWxl column（7. 8 mm × 300 mm,5μm） with mobile phase of phosphate buffer （ pH6. 8） （ containing 0. 1 mol· L- J Na2 SO4 and 0. 05 % NaN3 ）. The flow rate was 1.0ml·min^-1 , and the detection wavelength was at 280 nm. Results： The high polymer of peptide in protein hydrolysate injection was no more than 5%. Conclusion： The method is simple, reliable and accepted by the specification for controlling the high polymer of protein hydrolysate injection.
出处
《中国药品标准》
CAS
2011年第6期439-441,共3页
Drug Standards of China
关键词
水解蛋白注射液
高分子物质
分子排阻色谱法
Protein hydrolysate injection
High polymer
Sige-exclusion Chromatography
