不同来源复方甘草酸苷注射液中氨基酸含量测定及稳定性评价  

Quantitative determination and stability evaluation of amino acids in compound glycyrrhizin injection from different sources

作　　者：黄艳[1] 孙逍 何佳佳 孙楠[1] 谢升谷 HUANG Yan;SUN Xiao;HE Jia-jia;SUN Nan;XIE Sheng-gu(Zhejiang University of Technology,Hangzhou 310014;Zhejiang Institute for Food and Drug Control,National Medical Products Administration Key Laboratory for Core Technology of Generic Drug Evaluation,Hangzhou 310052,China)

机构地区：[1]浙江工业大学,杭州310014 [2]浙江省食品药品检验研究院,国家药品监督管理局仿制药评价关键技术重点实验室,杭州310052

出　　处：《药物分析杂志》2021年第9期1655-1662,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：浙江省药品监督管理局科技计划项目(2021005)。

摘　　要：目的:建立HPLC法测定不同来源复方甘草酸苷注射液中甘氨酸与盐酸半胱氨酸的含量,并对易降解氨基酸的稳定性进行考察、评价。方法:采用Agilent Eclipse XDB-C_(18)色谱柱(4.6 mm×150 mm,5μm),流动相为甲醇-0.01 mol·L^(-1)磷酸盐缓冲液(磷酸调pH 2.15±0.02)(5∶95),检测波长为210 nm。结果:不同生产企业的复方甘草酸苷注射液中,甘氨酸含量为99.1%~101.7%;原研制剂的盐酸半胱氨酸平均含量是103.9%,未检出胱氨酸,其他样品中盐酸半胱氨酸含量为50.7%~85.6%,能检出胱氨酸。结论:本方法无需样品前处理且准确度高,为复方甘草酸苷注射液的质量控制提供参考。不同生产企业的注射液中甘氨酸均较稳定;盐酸半胱氨酸含量参差不齐,部分样品含量较低、稳定性较差。盐酸半胱氨酸稳定性与pH和处方工艺均密切相关,不同来源注射液稳定性表现差异较大。部分仿制药生产企业需进一步优化处方工艺,提高药品质量。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-C_(18) 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.

关 键 词：复方甘草酸苷注射液 甘氨酸 盐酸半胱氨酸 胱氨酸 PH 处方工艺 稳定性 

分 类 号：R917[医药卫生—药物分析学]