| 陈琴琴,王凯,聂旋,等.磺胺甲唑血药浓度监测方法探索与临床应用[J].中国临床保健杂志,2026,(1):75-82. |
| 磺胺甲唑血药浓度监测方法探索与临床应用 |
| Exploration and clinical application of blood concentration monitoring method for sulfamethoxazole |
| 投稿时间：2025-11-15 |
| DOI：10.3969/J.issn.1672-6790.2026.01.013 |
| 中文关键词: 复方磺胺甲〖XC口恶F.tif %90%90,JZ〗唑 血药浓度 色谱法,高压液相 肺炎,细菌性 |
| 英文关键词: Sulfamethoxazole Plasma concentration Chromatography,high pressure liquid Pneumonia,bacterial Fund programs:National Natural Science Foundation of China |
| 基金项目:国家自然科学基金项目 |
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| 中文摘要: |
| 目的 建立一种简便快捷、准确稳定的适用于监测患者血清磺胺甲〖XC口恶F.tif;%90%90,JZ〗唑(SMZ)的高效液相色谱(HPLC)分析方法,为临床复方磺胺甲〖XC口恶F.tif;%90%90,JZ〗唑的个体化用药提供重要参考。方法 采用UltiMate 3000高效液相色谱仪,色谱条件:Hypersil ODS2色谱柱(250 mm×4.6 mm,5 μm),柱温:25 ℃。流动相:水(A相,0.1%乙酸)-乙腈(B相)=77-23。紫外检测波长:257 nm,流速:1 mL/min,进样量:50 μL。在实验过程中,进行专属性验证、残留可靠性检测与稳定性考察,制作标准曲线并计算不同实验条件下的回收率与精密度,同时将该监测方法应用于临床患者的SMZ血药浓度测定。结果 SMZ色谱峰峰型尖锐,分离良好,血清浓度在8.04~257.40 mg/L范围内线性良好,回归方程为S=0.321C+0.456 1(r=0.999 5)。低、中、高浓度血清样品相对回收率在105.10%~108.99%之间,提取回收率为(102.23±4.73)%,日内与日间精密度RSD值均<5%。对21例次使用SMZ进行耶氏肺孢子菌肺炎(PJP)预防和治疗的患者进行血药浓度监测,治疗性使用SMZ患者血药浓度个体化差异明显,血药浓度(136.70±31.19)mg/L,预防性使用SMZ患者血药浓度(23.66±8.61)mg/L,均未发生PJP。结论 HPLC法操作简便、特异性强、稳定性好、结果准确且成本低,适用于临床SMZ血药浓度的常规监测。 |
| 英文摘要: |
| Objective To establish a simple,rapid,accurate and stable high performance liquid chromatography (High Performance Liquid Chromatography,HPLC) method for monitoring the concentration of serum sulfamethoxazole (Sulfamethoxazole,SMZ) in patients,so as to provide important reference for clinical individualized drug use of compound sulfamethoxazole.Methods The UltiMate 3000 high performance liquid chromatograph was used.The chromatographic conditions were Hypersil ODS2 column (250 mm×4.6 mm,5 μm),and the column temperature was 25 ℃.Mobile phase:Water (phase A,0.1% acetic acid)-acetonitrile (phase B)=77-23.UV detection wavelength:257 nm,flow rate:1 mL/min,sample size:50 μL.During the experiment,a comprehensive set of evaluations including specificity verification,residual reliability testing,and stability assessment were conducted simultaneously.Standard curves were created and the recovery rates and precision under different experimental conditions were calculated.At the same time,the monitoring method was applied to the determination of blood concentrations of SMZ in clinical patients.Results The SMZ chromatographic peak-to-peak pattern was sharp,and the serum concentration was well linear in the range of 8.04-257.40 mg/L.The regression equation was S=0.321C+0.456 1 (r=0.999 5).The relative recoveries of low,medium and high concentration serum samples ranged from 105.10%-108.99%,and the average recovery was (102.23±4.73)%.The RSD values of intraday and daytime precision were all less than 5%.Blood concentrations were monitored in 21 patients who used SMZ for prevention and treatment of Pneumocystis jirovecii pneumonia (PJP).There was a significant difference in individual blood concentrations in patients who used SMZ therapeutically.The mean blood concentrations were (136.70±31.19) mg/L.The mean plasma concentration of SMZ patients was (23.66±8.61) mg/L,and no PJP occurred.Conclusions The established HPLC method is simple,specific,stable,accurate and low-cost,and is suitable for routine monitoring of blood concentration of SMZ. |
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