HPLC-ELSD Detection of Macromolecular Substances in Compound Kushen Injection
HAI Li-na1,2, BI Xiao-feng1, DUAN Xiu-mei1, ZHANG Ya-meng1, QIN Wen-jie1*, YANG Xiu-wei3*
1. Beijing Zhendong Guangming Pharmaceutical Research Institute, Beijing 100085, China; 2. Academy for Advanced Interdisciplinary Studies, Peking University, Beijing 100871, China; 3. State Key Laboratory of Natural and Biomimetic Drugs,Department of Natural Medicines,School of Pharmaceutical Sciences,Peking University,Beijing 100191, China
Abstract：OBJECTIVE To establish a high-performance liquid gel chromatography (HPLC-ELSD) method for the detection of macromolecular substances in Compound Kushen injection. METHODS TSKgel G2000SWXL (7.8 mm×300 mm, 5 μm) chromatographic column was used. A 20 mmol·L-1 ammonium acetate aqueous solution was used as the mobile phase. The column temperature was maintained at 25 ℃, the flow rate was 0.8 mL·min-1, and the parameters of the evaporative light detector (drift tube temperature 55 ℃, atomization temperature 55 ℃, nitrogen flow rate, 1.8 L·min-1), a method for detecting macromolecular substances was established, and eleven batches of Compound Kushen injection were tested for macromolecular substances. RESULTS No macromolecular substances was detected in the eleven batches of Compound Kushen injection, indicating that after the step-by-step removal of impurities, macromolecular substances have been removed from the finished Compound Kushen injection products. CONCLUSION This method is simple and fast, which can be used for the detection of macromolecular substances in Compound Kushen injection, it provides a basis for improving the quality standards of Compound Kushen injection.
REN Y J, ZHANG H L. Progress in clinical application of Fufangkushen injection . Mod Med Health(现代医药卫生), 2008,24(5):715-717.
[2]
MA Y, ZHANG Q W, WANG Z M, et al. Research progress of Fufangkushen injection . Chin J Exp Tradit Med Form(中国实验方剂学杂志), 2012, 18(23): 342-345.
[3]
LI C M, ZHANG Z J, SHI Y. Clinical application of Fufangkushen injection . J Dis Mon Control(疾病监测与控制), 2010, 4(6): 330-332.
[4]
PENG F, YE Z L, LI D K, et al. HPGPC-ELSD method for detecting glycoside macromolecules in Yiqi Fumai (lyophilized) for injection . Chin Tradit Pat Med(中成药), 2014, 36(5): 1098-1100.
[5]
QI Y, YUAN B, WU X Y, et al. Study on screening method of macromolecular substances in Danhong injection . Chin J Pharm Anal(药物分析杂志), 2016, 36(8): 1451-1455.
[6]
Ch.P( 2015). Vol Ⅳ( 中国药典2015 年版.四部). 2015:225.
[7]
GU D H, ZHANG L, LI J C, et al. Study on screening method of macromolecular substances in traditional Chinese medicine injections . Chin Pharm J(中国药学杂志), 2014, 49 (1): 64-67.
[8]
WANG X, ZHANG W, LI J C, et al. Determination of macromolecular substances in Ginkgo bilobalide lactone extract by high performance liquid size exclusion chromatography . Chin Tradit Herb Drugs(中草药), 2016,47(3):436-439.
[9]
TU H. Study on quantitative detection of macromolecular substances in Honghua injection . China Pharm(中国药业), 2014, 23(17): 51-52. LI Y X, YANG L W, HU K, et al. Preliminary study on high molecular substances in traditional Chinese medicine injections . Drug Stand China(中国药品标准), 2012, 13(1): 22-25. LU W, MA X, DING R, et al. Determination of molecular weight and molecular weight distribution of basil polysaccharide by high performance gel chromatography . China Pharm(中国药业), 2012, 21(8): 32-33. XIAO X, FU Y, CHEN L, et al. High-performance gel permeation chromatography study of relative molecular mass of macromolecular substances in Qingkailing injection. Chin Pharm J(中国药学杂志), 2011, 46(24):1946-1948.
2020, Vol. 55 
