Objective: To establish an HPLC method for the determination of glycine and cysteine hydrochloride in compound glycyrrhizin injection from different sources,and to investigate and evaluate the stability of degradable amino acids. Methods: Agilent Eclipse XDB-C18 column (4.6 mm×150 mm,5 μm) was used. The mobile phase was methanol-0.01 mol·L-1 phosphate buffer (adjusted to pH 2.15±0.02 with phosphoric acid) (5∶95). The detection wavelength was 210 nm. Results: The content of glycine in compound glycyrrhizin injection from different manufacturers was 99.1%-101.7%;the average content of cysteine hydrochloride from brand manufacturer was 103.9%,and cystine was not detected. In samples from generic manufacturers,the content of cysteine hydrochloride was 50.7%-85.6%,and cystine was detected. Conclusion: This method needs no sample pretreatment and has high accuracy,which can provide reference for the quality control of compound glycyrrhizin injection. Glycine in injections from different manufacturers is relatively stable;the content of cysteine hydrochloride varies considerably and some samples have low content and poor stability. The stability of cysteine hydrochloride is closely related to pH value and formulation. The stability of injections from different sources varies greatly. Some generic drug manufacturers need to further optimize the formulation process and improve the quality of drugs.
HUANG Yan, SUN Xiao, HE Jia-jia, SUN Nan, XIE Sheng-gu
. Quantitative determination and stability evaluation of amino acids in compound glycyrrhizin injection from different sources*[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(9)
: 1655
-1662
.
DOI: 10.16155/j.0254-1793.2021.09.20
[1] 张敏娟. RP-HPLC 测定注射用复方甘草酸苷中甘草酸铵含量和有关物质[J]. 药物分析杂志,2008,28(5):798
ZHANG MJ.RP-HPLC determination of ammonium glycyrrhizinate and related substances in compound glycyrrhizin for injection[J]. Chin J Pharm Anal,2008,28(5):798
[2] 施以梅. 复方甘草酸苷的临床应用进展[J]. 中国药房,2008, 19(3):234
SHI YM.Progress in clinical application of compound glycyrrhizin[J]. J China Pharm,2008,19(3):234
[3] 田莉,刘江杰,高晓黎. 生物样品中甘草酸及其代谢产物检测方法的研究进展[J]. 药物分析杂志,2009,29(2):340
TIAN L,LIU JJ,GAO XL.Progress in the detection of glycyrrhizin and glycyrrhetic acid in biological specimens[J]. Chin J Pharm Anal,2009,29(2):340
[4] QI S S,SHI W D,XU F,et al.The clinical efficacy and safety of oral compound glycyrrhizin in adult patients with mild-to-moderate active alopecia areata:a randomized controlled study[J]. Eur J Integr Med,2019,32:100975
[5] CINATL J,MORGENSTERN B,BAUER G,et al.Glycyrrhizin, an active component of liquorice roots,and replication of SARS-associated coronavirus[J]. Ther Lancet,2003,361(9374):2045
[6] YAO L,SUN T.Glycyrrhizin administration ameliorates Streptococcus aureus-induced acute lung injury.[J]. Int Immunopharmacol,2019,70(2):504
[7] LUO P,LIU D,LI J.Pharmacologic perspective:glycyrrhizin may be an efficacious therapeutic agent for COVID-19[J]. Int J Antimicrob Agents,2020,55(6):105995
[8] KENJIRO,KOGA,HIRONORI,et al. Comparative study for pharmaceutical quality among bland-name drug and generic drugs of compound glycyrrhizin injections in China[J]. J Basic Clin Pharm, 2012,3(4):346
[9] YBH25192005 国家药品监督管理局药品标准[S]. 2005
YBH25192005 The National Medical Products Administration Standard[S]. 2005
[10] YBH34322005 国家药品监督管理局药品标准[S]. 2005
YBH34322005 The National Medical Products Administration Standard[S]. 2005
[11] YBH15962006 国家药品监督管理局药品标准[S]. 2006
YBH15962006 The National Medical Products Administration Standard[S]. 2006
[12] YBH17252006 国家药品监督管理局药品标准[S]. 2006
YBH17252006 The National Medical Products Administration Standard[S]. 2006
[13] YBH18202006 国家药品监督管理局药品标准[S]. 2006
YBH18202006 The National Medical Products Administration Standard[S]. 2006
[14] YBH08182008 国家药品监督管理局药品标准[S]. 2008
YBH08182008 The National Medical Products Administration Standard[S]. 2008
[15] 蓝忠,林焕泽,黄群. HPLC 法测定复方甘草酸苷注射液中甘氨酸和盐酸半胱氨酸的含量[J]. 中国药师,2009,12(12):1770
LAN Z,LIN HZ,HUANG Q.Determination of glycine and cysteine hydrochloride in compound glycyrrhizin injection by HPLC[J]. Chin Pharm,2009,12(12):1770
[16] 薛晓,王爱明,刘颖,等. HPLC 法同时测定复方甘草酸苷注射液中甘氨酸与盐酸半胱氨酸的含量[J]. 中国新药杂志,2012,21(23):2804
XUE X,WANG AM,LIU Y,et al.Simultaneous determination of glycine and cyeteine hydrochloride in compound glycyrrhizin injection by HPLC[J]. Chin J New Drugs,2012,21(23):2804
[17] 方方,纪宇. 过甲酸氧化柱前衍生HPLC 法测定复方氨基酸注射液(18AA-Ⅴ)中盐酸半胱氨酸含量[J]. 海峡药学,2016,28(12):43
FANG F,JI Y.HPLC determination of cysteine hydrochloride in compound amino acid injection(18AA-V) with performic acid oxidation and pre-column derivatization[J]. Strait Pharm J,2016, 28(12):43
[18] COIFFARD C A,COIFFARD L J,PEIGNE F M,et al.Monoammonium glycyrrhizinate stability in aqueous buffer solutions[J]. J Sci Food Agric,2010,77(4):566
