| 刘倩,李震,张媛,吴彦霖,蔡彤,谭德讲,高华.首批醋酸特利加压素化学对照品的研制[J].中国药事,2019,33(4):402-407 |
| 首批醋酸特利加压素化学对照品的研制 |
| Development of the First Reference Standard of Terlipressin Acetate |
| 投稿时间：2018-11-01 |
| DOI：10.16153/j.1002-7777.2019.04.009 |
| 中文关键词: 醋酸特利加压素 标准物质定值 质量平衡法 对照品 |
| 英文关键词: terlipressin acetate value of standard material mass balance method reference standard |
| 基金项目:国家“重大新药创制”科技重大专项资助项目（2017ZX09101001） |
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| 中文摘要: |
| 目的：建立供含量测定用的首批醋酸特利加压素化学对照品。方法：应用红外光谱和液质联用仪等对醋酸特利加压素进行结构确证，采用高效液相色谱法测定样品色谱纯度、醋酸含量及氨基酸比值，同时测定水分和残留溶剂，以质量平衡法计算醋酸特利加压素的含量。结果：确定首批醋酸特利加压素对照品含量为85.4%。结论：首批醋酸特利加压素化学对照品的建立可有效控制产品质量。 |
| 英文摘要: |
| Objective: To establish the first reference standard for determination of the content of terlipressin acetate. Methods: IR and LC-MS Spectrometer were used to confirm the structure of terlipressin acetate. HPLC was used to determine the purity of the sample, the content of acetic acid and the ratio of amino acid. The moisture and residual solvents were simultaneously determined. Mass balance method was used to caculate the content of terlipressin acetate. Results: The content of the first reference standard of terlipressin acetate was 85.4%. Conclusion: The establishment of the first reference standard of terlipressin acetate can efficiently control the quality of products. |
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