目的:建立凝胶高效液相色谱(HPGPC)-电雾检测器(CAD)法测定右旋糖酐40葡萄糖注射液中右旋糖酐40分子量及分子量分布,与示差检测器(RID)测定结果进行比较。方法:采用HPGPC法,TSK G4000 PWXL色谱柱(300 mm×7.8 mm,10 μm),CAD检测器流动相为甲醇-0.02 mol·L-1甲酸铵(30∶70),RIP检测器流动相为0.71%硫酸钠溶液(内含0.02%叠氮化钠),使用WATERS公司GPC软件计算分子量及分子量的分布。结果:2种方法测定右旋糖酐40分子量线性范围均为2 700～300 600,HPGPC-CAD法线性良好(r＝0.997 2),精密度、稳定性、重复性试验(n=6)RSD分别为0.32%、0.23%、0.81%;HPGPC-RID法线性良好(r＝0.995 4),精密度、稳定性、重复性试验(n=6)RSD分别为0.20%、0.15%、0.26%。结论:2种方法稳定、可靠,均可用于右旋糖酐40分子量及分子量分布的测定。
Objective: To establish an HPGPC-CAD method for the determination of molecular mass and molecular mass distribution of dextran 40,and to compare the result with the HPGPC-RID method. Methods: Molecular mass and molecular mass distribution of dextran 40 were determined by HPGPC with TSK G4000 PWXL column(300 mm×7.8 mm,10 μm), and the mobile phase for HPGPC-CAD was methanol-0.02 mol·L-1 ammonium formate (30∶70). And the mobile phase for HPGPC-RID was 0.71% sodium sulfate solution, containing 0.02% sodium azide), the results were handled with the WATERS GPC software. Results: HPGPC-CAD determination showed that the linear range was 2 700-300 600 (r=0.997 2),and the precision, stability, repeatability (n=6) were 0.32%, 0.23%, 0.81%, respectively. In comparison, HPGPC-RID determination showed that the linear range was 2 700-300 600 (r=0.995 4),and the precision, stability, repeatability (n=6) was 0.20%, 0.15%, and 0.26%, respectively. Conclusion: Both HPGPC-CAD and HPGPC-RID methods are stable and reliable, and can be used for the determination of molecular mass and molecular mass distribution of dextran 40.
[1] 张九花, 常国炜, 马步,等. 右旋糖酐制备及其应用研究进展[J].甘蔗糖业, 2018(2):52
ZHANG JH, CHANG GW, MA B, et al.Progress in preparation and application of dextran[J].Sugar Canes, 2018(2):52
[2] 郭代红, 崔巍, 孟潇. 血容量扩充药及其临床应用[J].药物流行病学杂志, 2003, 12(4):188
GUO DH, CUI W, MENG X.Blood volume extender and its clinical application[J].J Pharmacoepidemiol,2003, 12(4):188
[3] 黄文起. 人工胶体液代用品分类和临床应用[J].中国实用外科杂志, 2007,27(8):599
HUANG WQ.Classification and clinical application of artificial colloidal fluid substitutes[J].Chin J Pract Surg, 2007,27(8):599
[4] 尹秀英. 右旋糖酐40葡萄糖注射液对透析中低血压的疗效[J].当代医学,2016,22(20):42
YING XY. Effect of dextran 40 glucose injection on hypotension during dialysis[J].China Contemp Med,2016,22(20):42
[5] 黎珍. 探究低分子右旋糖酐辅助治疗急性脑梗死的临床效果[J].临床医药文献杂志, 2018, 5(44):93
LI Z.To explore the clinical effect of low molecular dextran in the treatment of acute cerebral infarction[J].J Clin Med,2018, 5(44):93
[6] 易爱纯, 陈蒂芳, 张顺芝. 右旋糖酐40不良反应695例分析[J].中国药房, 1998, 9(3):128
YI AC, CHEN DF, ZHANG SZ. Analysis of 695 cases developing adverse reactions of dextran 40[J].Chin Pharm, 1998, 9(3):128
[7] 刘路, 高旋, 杨永健. HPLC-电雾式检测器的应用[J].中国医药工业杂志, 2012, 43(3):227
LIU L, GAO X, YANG YJ. Application of HPLC-charged aerosol detection[J].Chin J Pharm,2012, 43(3):227
[8] 孙亚飞, 赵恂, 张玫,等. HPLC-CAD法测定乳糖含量及有关物质[J].药物分析杂志, 2018, 38(5):894
SUN YF, ZHAO X, ZHANG M, et al. Determination of lactose and its related substances by HPLC-CAD[J].Chin J Pharm Anal, 2018, 38(5):894
[9] 刘立洋, 刘肖. 一种新型的通用型检测器——电喷雾检测器[J].现代科学仪器, 2011(5):141
LIU LY, LIU X.An innovative universal detector—corona charged aerosol detector[J].Mod Sci Instrum,2011(5):141
[10] 中华人民共和国药典2020年版.二部[S]. 2020:203
ChP 2020.Vol Ⅱ[S]. 2020:203
[11] 赵峡,杨海,宋乐天,等.不同色谱柱和GPC软件对灰树花倍他葡聚糖相对分子质量测定的影响[J].药物分析杂志,2007,27(8):1143
ZHAO X,YANG H,SONG LT, et al. Influence of different chromatograph columns and GPC softwares on relative molecular mass determination of Grifola frondosa beta-glucan[J].Chin J Pharm Anal,2007,27(8):1143
[12] 程冬. 色谱柱及标准曲线的选择对HPGPC法测定右旋糖酐分子量及分子量分布的影响[J].药物分析杂志, 2020, 40(2):367
CHENG D.Influence of different chromatograph columns and standard curves on molecular mass and molecular mass distribution of dextran by HPGPC[J].Chin J Pharm Anal, 2020, 40(2):367
[13] 王其宇. HPGPC法在右旋糖酐原料药生产质控中的应用[J].安徽化工, 2001,27(3):45
WANG QY.Application of HPGPC method in quality control of dextran API production[J].Anhui Chem Ind,2001,27(3):45
[14] 万丹晶, 陈妙芬, 陈钢. 右旋糖酐铁注射液峰位相对分子质量和重均相对分子质量的HPGPC测定[J].药物分析杂志, 2007,27(5):708
WAN DJ, CHEN MF, CHEN G. HPGPC determination of iron dextran peak relative molecular mass and weight mean relative molecular mass in iron dextran injections[J].Chin J Pharm Anal, 2007,27(5):708
[15] 范慧红, 刘金秀, 徐康森. 高效凝胶渗透色谱法在右旋糖酐铁质控中的应用[J].药物分析杂志, 2000,20(4):254
FAN HH, LIU JX, XU KS.Application of high performance gel permeation chromatography in iron control of dextran[J].Chin J Pharm Anal,2000,20(4):254
