摘要
目的:建立高效分子排阻色谱法(HPSEC)检测中药注射液中的高分子量物质。方法:采用TSK-GEL G2000SWXL(7.8mm×300 mm)凝胶色谱柱;三氟乙酸-乙腈-水(0.05∶30∶70)为流动相;流速为0.4mL.min-1;检测波长为214 nm。结果:相对分子质量在1 521～13 700范围内线性关系良好(r=0.995);检测限以细胞色素C计为50 ng,以血清白蛋白计为15ng;验证实验良好。结论:本方法适合检测中药注射液中的高分子量物质,方法简便,准确,灵敏度好。
Objective： To establish a high performance size exclusion chromatography （HPSEC） method for the determination of high molecular weight substance （ HMWS ） in traditional chinese medicine （ TCM ） injection. Methods ： The chomatographic, column TSK G2000 SWxL （7.8 mm × 300 mm） was used with trifluoroaeetic acid-acetonitrile-water（0. 05：30： 70） as the mobile phase at a flow rate of 0.4 mL·min-1, and the detection wavelength was at 214 nm. Results： In the range of 1 521 - 13 700 of substance molecular weights, a linearity was achieved with r of 0. 995. The detection limit of cytochrome C and serum albumin were 50 ng and 15 ng, respectively. And the chromatographys of recovory test is convincing. Conclusion： The method is suitable for determination of high molecular weight substance in TCM Injection. Moreover,it is simple, accurate, and sensitive.
出处
《中国药品标准》
CAS
2011年第5期353-355,共3页
Drug Standards of China
