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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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等温微量热技术快速评价头孢曲松钠的体外抑菌效果

Rapid antibacterial activity test of ceftriaxone sodium in vitro by isothermal microcalorimetry

作者(英文):
分类号:R917
出版年·卷·期(页码):2019,39 (4):722-729
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:开发一种基于等温微量热技术实时测定头孢曲松钠体外抑菌效果的快速检测方法。方法:摸索金黄色葡萄球菌株起始接种量的范围和头孢曲松钠溶液检测浓度的区间,确定可用于快速分析的热谱图参数,比较测试药品与原研药品(罗氏芬)在拉曼光谱、X射线衍射谱、抗生素效价测定、高效液相色谱和体外微量热图谱的差异。结果:以105 CFU·mL-1的金黄色葡萄球菌为起始浓度,头孢曲松钠溶液质量浓度(Cn)在0.25~0.80 mg·mL-1时与含药物的微生物热谱图主峰相对出峰时间的归一化值(α)存在正相关线性关系(R2=0.99);同时,头孢曲松钠溶液Cn和含药物的微生物热谱图曲线主峰斜率的归一化值(β)存在负相关线性关系(R2=0.89)。微量热法检测的测试药品体外抑菌活性比罗氏芬相比低约8%,其结果与传统管碟法测试结果相同。X射线衍射粉末衍射结果显示两者晶型组成不同。结论:微量热技术具有灵敏度高及精密度好的特点,可实时检测抗生素体外抑菌活性,在快速评价抗生素效价领域具备较好的应用前景。

-----英文摘要:---------------------------------------------------------------------------------------

Objective:To develop a rapid method of isothermal microcalorimetry detection technology for the real-time test of antibacterial activity of ceftriaxone sodium in vitro. Methods:The range of initial bacterial concentration, ceftriaxone sodium concentration and parameters from heat flow curves were tested and optimized using Staphylococcus aureus ATCC 6538, respectively. The generic ceftriaxone sodium and original drug (Rocephin) were compared by Raman spectra, X-ray powder diffraction spectra, cylinder-plate method and HPLC method. Results:When mass concentration (Cn) of ceftriaxone sodium was between 0.25 mg·mL-1 and 0.80 mg·mL-1, Cn had a positive linear relationship with the relative time difference (α) for the main heat-flow peak (R2=0.99), using 105 CFU·mL-1 of S. aureus initial concentration. Meanwhile, Cn had a negative linear relationship with the relative slope (β) for the main heat flow peak (R2=0.89). The antibacterial activity of generic ceftriaxone sodium in vitro by isothermal microcalorimetry was 8% lower than that of Rocephin, and the same result was confirmed by cylinder-plate method. However, X-ray powder diffraction spectra showed a significant difference in their crystal form. Conclusion:Isothermal microcalorimetry is a rapid, sensitive, precision and useful technology to test antibacterial activity in real-time with a good application prospect.

-----参考文献:---------------------------------------------------------------------------------------

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