Evaluation Of Quality Control System And Clinical Application Analysis Of Aminophylline Blood Concentration Monitoring

Objective:To establish a two-dimensional chromatography method for deter mining the steady-state concentration of aminophylline in human serum;To evalu ate the quality control of aminophylline in serum,and to improve the monitoring quality of aminophylline therapeutic drugs;To collect the clinical data of amino phylline serum concentration monitoring patients,analyze the influencing factors of aminophylline serum concentration,promote the rational use of aminophylline.Method:（1）A method for the determination of aminophylline blood concentration was established by two-dimensional high liquid chromatography,and the biological analysis methodology was verified according to Pharmacopoeia of the People’s Republic of China（2020 Edition）.（2）After statistical collating of the measured values of low,medium and high concentration aminophylline quality control products,the monitored data were drawn into Levey-Jennings and Z-fraction quality control charts,and the indoor quality control quality of aminophylline was judged based on the quality control charts drawn by Westgard’s multi-rule theory.（3）The established two-dimensional high performance liquid chromatography method was applied to clinical practice,and statistical software was used to retrospectively analyze the clinical data of inpatient blood concentration monitoring of aminophylline.Result:（1）A method for the determination of aminophylline plasma concentration was established by two-dimensional high liquid chromatography,and the selectivity,residue,lower limit of quantification,standard curve,accuracy,precision and stability of biological analysis methodology were verified.（2）After statistical collating of the measured values of low,medium and high concentration aminophylline quality control products,the monitored data were drawn into Levey-Jennings and Z-fraction quality control charts,and the indoor quality control quality of aminophylline was judged based on the quality control charts drawn by Westgard’s multi-rule theory.（3）Retrospective analysis of 42 patients included in this study found that age,globulin,urea,uric acid,platelet count,lymphocyte count,erythrocyte volume ratio,oxygen partial pressure,oxygen partial pressure difference of alveolar artery were significantly correlated with aminophylline plasma concentration.There was no correlation between the blood concentration of aminophylline and gender,smoking history,different dosing methods,dosing dosage.There was no significant difference in blood concentrations of six types of cephalosporins,carbapenems,penicillins,quinolones,tetracyclines and nitroimidazoles when combined with aminophylline.Analysis of aminophylline combined with ketotifen,midazolam,cimetidine,salbutamol and terbutaline showed that there were differences in the blood concentration of aminophylline between the five drugs,but the analysis results of multiple comparisons showed that the difference was not significant.Aminophylline blood drug concentration in 1～5μg.m L^-1.with in 5～15μg.m L^-1there was a significant difference within the scope of the treatment efficient and effective treatment in patients with 52.60%from blood drug concentration in 5～15μg.m L^-1within the scope of the patients,Treatment is invalid in 95.45%of patients from blood drug concentration in 1～5μg.m L^-1within the scope of the patients.Conclusion:（1）The aminophylline two-dimensional high performance liquid chromatography used can be used for the analysis of aminophylline plasma samples in clinical practice.（2）Evaluation of indoor quality control of aminophylline blood concentration monitoring can improve the accuracy of test results and ensure the reliability of the report.（3）When the blood concentration of aminophylline is less than5μg.m L^-1,the effective rate is low,and it is recommended to increase the dose according to the patient’s condition.There is a large difference between individuals using aminophylline,and there are many factors affecting blood drug concentration.The efficacy should be evaluated comprehensively based on patients’age,liver and kidney function indexes,oxygen partial pressure level and combined drug use,and blood drug concentration monitoring should be carried out when necessary to ensure the rational use of aminophylline.