| 刘景坤,廖海明,张斗胜,范慧红.首批L-犬尿氨酸国家药品对照品的研制[J].中国药事,2023,(11):1326-1331 |
| 首批L-犬尿氨酸国家药品对照品的研制 |
| Development of the First Batch National Reference Standard of L-kynurenine |
| 投稿时间：2023-04-24 |
| DOI：10.16153/j.1002-7777.2023.11.013 |
| 中文关键词: 犬尿氨酸 对照品 结构确证 含量测定 |
| 英文关键词: L-kynurenine reference standard structure confirmation content determination |
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| 中文摘要: |
| 目的：建立首批L-犬尿氨酸国家对照品。方法：采用紫外吸收光谱、红外吸收光谱、核磁共振谱及高分辨质谱对犬尿氨酸进行结构确证，测定了原料的水分含量、炽灼残渣量及元素含量，并考察了其引湿性、均匀性和稳定性，最后采用氮分析法、液相色谱法及定量核磁共振法对其含量进行测定，最后采用质量平衡法对其含量进行赋值。结果：确证了犬尿氨酸的结构，以质量平衡法计算，将本批次犬尿氨酸的含量定值为97.4%。结论：经过结构确证和含量测定，本批次犬尿氨酸能够满足相关药品检查使用，首批L-犬尿氨酸国家对照品研制成功并通过审定，可用于相关氨基酸药物的检查，有利于提高相关药品质量，保证用药安全。 |
| 英文摘要: |
| Objective: To establish the first batch of national reference standard of L-kynurenine. Methods: The molecular structure of kynurenine was confirmed by the spectrum methods of UV, IR, NMR and high resolution MS. Moreover, the moisture content, residual ignition content and element content of the raw material were determined, and its hygroscopicity, homogeneity and stability were also observed. Finally, nitrogen analysis, HPLC and quantitative NMR were applied in the measurement, and mass balance method was used to determine its contents. Results: The structure of L-kynurenine was confirmed, and the content of L-kynurenine in this batch was determined to be 97.4% by mass balance method. Conclusion: This batch of L-kynurenine could meet the requirements of related drug detection after structure confirmation and contents determination. The first batch of national reference standard of L-kynurenine has been successfully developed and approved, and it is used for the detection for related amino acid drug, which is helpful in improving drug quality of related drugs and guaranteeing drug safety. |
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