【摘要】 目的建立分子排阻色谱法测定中药注射剂中大分子物质,用于中药注射剂中大分子物质的筛查。方法运用分子排阻色谱法,分别采用紫外检测器和示差检测器进行检测。以Phenomenon BioSep-SEC-s2000(7.8 mm×300 mm,8μm)为色谱柱,以右旋糖酐为对照品时,以0.05 mol·L-1Na2SO4为流动相,示差检测器检测;以蛋白质为对照品时,以0.1%三氟乙酸-乙腈(70∶30)为流动相,用紫外检测器,波长为214 nm。结果在示差检测器条件下,右旋糖酐对照品相对分子质量在7 100~133 800内线性关系良好,检测限为0.097 9μg,精密度和稳定性均良好,RSD均在0.4%内;胸腺素相对分子质量分布对照品相对分子质量在1 638~13 700内线性关系良好,检测限为0.003 58μg,精密度和稳定性良好,RSD均在0.2%内。选择的几种中药注射剂均未检出大分子物质。结论建立的方法可用于中药注射剂大分子物质初步检查。更多还原

【Abstract】 OBJECTIVE To establish methods for screening of macromolecules in traditional Chinese medicine injections by molecular exclusion chromatography( SEC). METHODS The separation was carried out by SEC with Phenomenon BioSep-SEC-s2000( 7. 8 mm ×300 mm,8 μm) column. The mobile phase was 0. 05 mol·L- 1Na2SO4,and differential detector was used when dextran was used as the reference standard. When proteins were used as reference standards,the mobile phase was the mixture of 0. 1% trifluoroacetic acid and acetonitrile( 70∶ 30),and UV detector was selected. RESULTS With the differential detector,the molecular weight range of dextran was 7 100-133 800,and the limit of detection was 0. 097 9 μg; with the UV detector,the molecular weight range of the proteins was 1 638-13 700,and the limit of detection was 0. 003 58 μg. No macromolecules were detected in the selected traditional Chinese medicine injections. CONCLUSION The proposed method can be used for the screening of macromolecules in traditional Chinese medicine injections.更多还原