中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2014年
17期
51-51,52
,共2页
红花注射液%大分子物质%高效凝胶渗透色谱
紅花註射液%大分子物質%高效凝膠滲透色譜
홍화주사액%대분자물질%고효응효삼투색보
Honghua Injection%macromolecular substance%high performance gel permeation chromatography
目的：建立红花注射液中大分子物质的含量测定方法。方法采用高效凝胶渗透色谱法，以右旋糖酐D4为对照品，建立了红花注射液中大分子物质的检测方法，并对3批红花注射液样品进行检测。色谱柱为TSK-Gel G4000 PWXL凝胶柱（300 mm ×7.8 mm），流动相为10 mmol/L醋酸铵溶液，柱温为40℃，流速为0.6 mL/min，蒸发光散射检测器（氮气流速2.5 L/min，漂移管温度100℃）。结果红花注射液中存在大分子物质，相对分子质量为15517；对其含量测定发现，该品种大分子物质含量较低。结论该方法稳定、操作简单，可用于红花注射液质量标准提高研究。
目的：建立紅花註射液中大分子物質的含量測定方法。方法採用高效凝膠滲透色譜法，以右鏇糖酐D4為對照品，建立瞭紅花註射液中大分子物質的檢測方法，併對3批紅花註射液樣品進行檢測。色譜柱為TSK-Gel G4000 PWXL凝膠柱（300 mm ×7.8 mm），流動相為10 mmol/L醋痠銨溶液，柱溫為40℃，流速為0.6 mL/min，蒸髮光散射檢測器（氮氣流速2.5 L/min，漂移管溫度100℃）。結果紅花註射液中存在大分子物質，相對分子質量為15517；對其含量測定髮現，該品種大分子物質含量較低。結論該方法穩定、操作簡單，可用于紅花註射液質量標準提高研究。
목적：건립홍화주사액중대분자물질적함량측정방법。방법채용고효응효삼투색보법，이우선당항D4위대조품，건립료홍화주사액중대분자물질적검측방법，병대3비홍화주사액양품진행검측。색보주위TSK-Gel G4000 PWXL응효주（300 mm ×7.8 mm），류동상위10 mmol/L작산안용액，주온위40℃，류속위0.6 mL/min，증발광산사검측기（담기류속2.5 L/min，표이관온도100℃）。결과홍화주사액중존재대분자물질，상대분자질량위15517；대기함량측정발현，해품충대분자물질함량교저。결론해방법은정、조작간단，가용우홍화주사액질량표준제고연구。
Objective To establish the content determination method of the macromolecular substance in Honghua Injection. Methods The high performance gel permeation chromatography ( HPGPC ) was adopted to establish the determination method of the macromolecu-lar substance in Honghua Injection with dextran D4 as the reference substance and 3 batches of Honghua Injections sample were deter-mined. The chromatographic column was the TSK-Gel G4000 PWXL column ( 300 mm × 7. 8 mm );the mobile phase was 10 mmol/L am-monium acetate solution;the column temperature was 40℃;the flow rate was 0. 6 mL/min. The evaporative light scattering detector was used with the nitrogen flow rate of 2. 5 L/min and the drift tube temperature of 100℃. Results The macromolecular substance existed in Honghua Injection, the relative molecular weight was 15 517, detecting its content found that its content was lower. Conclusion This method is stable and easy to operate, and can be used to the study on the quality standard improvement of Honghua Injection.
