HPLC测定复方牛胎肝提取物片中的总氨基酸  

Determination of total amino acids in Compound embryonic bovine liver extract tablets by HPLC

作　　者：段艳 周长明 武晗燕 DUAN Yan;ZHOU Changming;WU Hanyan(Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Institute for Drug Control,Beijing,102206 P.R.China)

机构地区：[1]北京市药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《华西药学杂志》2022年第5期549-552,共4页West China Journal of Pharmaceutical Sciences

基　　金：国家药典委员会药品标准提高课题资助项目(2017103)。

摘　　要：目的 采用HPLC法测定复方牛胎肝提取物片中总氨基酸的含量。方法 采用Agilent Zorbax Eclipse AAA-C色谱柱(150 mm×4.6 mm, 5μm),流动相A为pH7.8磷酸二氢钠溶液,流动相B为甲醇-乙腈-水(45:45:10),梯度洗脱,肌氨酸、脯氨酸的检测波长分别为338、262 nm,柱温40℃,流速2.0 mL·min^(-1)。测定了国内3家企业共9批产品中的总氨基酸。结果 复方牛胎肝提取物片中各氨基酸的专属性、连续进样精密度均良好,r均大于0.9989,定量限约1.18~2.83μg·mL^(-1),平均加样回收率为98.2%~109.7%。不同厂家不同原料来源与生产工艺的产品中总氨基酸的含量有差别。结论 所用方法可用于复方牛胎肝提取物片中总氨基酸的含量检测,也可为其他多肽类药物中总氨基酸的含量测定提供参考。OBJECTIVE To detect the total amino acids in Compound embryonic bovine liver extract tablets by HPLC.METHODS The determination was performed on Agilent Zorbax Eclipse AAA-C(150 mm×4.6 mm, 5 μm) column.Mobile phase A was sodium dihydrogen phosphate solution(pH7.8) and mobile phase B was methanol-acetonitrile-water(45:45:10) by gradient elution.Column temperature was set as 40 ℃,and flow rate was 2.0 mL·min^(-1).The program wavelengths were 338 nm and 262 nm for sarcosine and proline.A total of 9 batches of products by 3 pharmaceutical manufactures were applied.RESULTS The method was accurate, stable and reproducible, and the linear relationship was good(r≥0.9989).The average recovery was between 98.2% and 109.7%(n=9).In the determination results, there were differences in productions in the 3 pharmaceutical manufactures.CONCLUSION The method can provide a reference for determination of total amino acids in Compound embryonic bovine liver extract tablets and other polypeptide drugs.

关 键 词：复方牛胎肝提取物片 总氨基酸 含量测定 高效液相色谱 方法学 多肽类药物 质量标准 质量评价 

分 类 号：R917[医药卫生—药物分析学]