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中国药物评价 ›› 2024, Vol. 41 ›› Issue (4): 299-301.

• 评价技术与方法 • 上一篇    下一篇

亚甲基蓝测定不同效价肝素钠含量的研究

 何鹏媛, 戴鹏, 朱建东, 汪毅   

  1. 江西三鑫医疗科技股份有限公司, 江西 南昌 330200
  • 收稿日期:2024-04-22 修回日期:2024-05-16 出版日期:2024-08-28 发布日期:2024-08-28
  • 基金资助:
    复合抗凝血涂层的研究开发及应用(20232BBG70017)

Study on the Determination of Heparin Sodium Contents of Different Potencies by Methylene Blue

  1. Jiangxi Sanxin Medical Technology Co., Ltd, Jiangxi Nanchang 330200, China
  • Received:2024-04-22 Revised:2024-05-16 Online:2024-08-28 Published:2024-08-28

摘要: 目的:对不同效价肝素钠的含量和活性进行评价。方法:建立了测定肝素钠浓度的紫外分光光度法,并探究了不同效价肝素钠对测定的影响。结果:在664 nm波长下,当肝素钠浓度在0~2.00 mg·L-1范围内,其与等量亚甲基蓝反应后,所测得的吸光度与肝素钠的浓度呈良好的线性关系,150 USP units·mg-1、185 USP units·mg-1和205 USP units·mg-1肝素钠线性方程的相关系数分别为0.999 6、0.999 2和0.999 0。研究发现肝素钠的效价与线性方程的斜率存在正相关关系,即随着肝素钠的效价的增加,斜率亦呈增加趋势。结论:本研究建立的方法可以对大批量样品进行简便、快速、易于控制的肝素钠定量测定并能间接探究肝素的活性。

关键词: font-size:medium, ">肝素钠;亚甲基蓝;紫外分光光度法

Abstract:  Objective: Evaluation of the content and activity of heparin sodium with different potencies. Methods: An ultraviolet spectrophotometric method for the determination of heparin sodium concentration was developed and the effect of different potencies of heparin sodium on the determination was investigated. Results: At the wavelength of 664 nm, the absorbance measured after its reaction with an equal amount of methylene blue showed a good linear relationship with the concentration of sodium heparin when the concentration of heparin sodium was in the range of 0-2.00 mg·L-1. The correlation coefficients of the linear equations for 150 USP units·mg-1, 185 USP units·mg-1, and 205 USP units·mg-1 heparin sodium were 0.999 6, 0.999 2, and 0.999 0, respectively. In addition, it was found that there was a positive correlation between the potency of heparin sodium and the slope of the linear equation, that is, as the potency of heparin sodium increased, the slope also increased. Conclusion: The method developed in this study allows for simple, rapid, and easily controlled quantitative determination of heparin and indirect investigation of heparin activity in large samples.

Key words: font-size:medium, ">Heparin Sodium; Methylene Blue; Ultraviolet Spectroscopy

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