| 刘莉莎,邓利娟,任雪,范慧红.首批矛头蝮蛇血凝酶国家标准品及对照品的研制[J].中国药事,2019,33(12):1456-1463 |
| 首批矛头蝮蛇血凝酶国家标准品及对照品的研制 |
| Development of the First Batch of National Reference Material and the Control Material for Hemocoagulase Bothrops Atrox |
| 投稿时间：2019-05-09 |
| DOI：10.16153/j.1002-7777.2019.12.020 |
| 中文关键词: 矛头蝮蛇血凝酶 标准品 对照品 首批 质量分析 |
| 英文关键词: hemocoagulase bothrops atrox reference material control material first batch quality analysis |
| 基金项目: |
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| 中文摘要: |
| 目的：建立首批矛头蝮蛇血凝酶国家标准品及对照品。方法：对矛头蝮蛇血凝酶标准品进行了理化分析、效价测定及稳定性考察；对矛头蝮蛇血凝酶对照品进行了结构确证、纯度考察、理化分析及稳定性考察。结果：建立了效价定值为101单位/支的矛头蝮蛇血凝酶标准品用于效价测定；建立了结构准确、纯度较高的矛头蝮蛇血凝酶对照品用于鉴别及检查测定。结论：首批矛头蝮蛇血凝酶国家标准品及对照品的研制规范了相关药品质量，为酶类生化药物的质量研究提供了思路及依据。 |
| 英文摘要: |
| Objective: To establish the first batch of national reference material and the control material for hemocoagulase bothrops atrox. Methods: The physicochemical analysis, titer determination and stability testing of the reference material for hemocoagulase bothrops atrox were carried out. The structural identification, purity testing, physicochemical analysis and stability testing of the control for hemocoagulase bothrops atrox were carried out. Results: The titer of the hemocoagulase bothrops atrox used for titer determination was 101 units per ampoule. The control material with accurate structure and high purity was established for identification and testing. Conclusion: The establishment of the first batch of the reference material and the control material for hemocoagulase bothrops atrox can be applied to the quality control of drugs and lay a basis for the quality research on enzyme biochemical drugs. |
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