The current United States Pharmacopeia–National Formulary(USP–NF) includes more than 250 monographs of fixed dose combinations(FDCs), and some of them need to be updated due to incompleteness of impurity profiles an...The current United States Pharmacopeia–National Formulary(USP–NF) includes more than 250 monographs of fixed dose combinations(FDCs), and some of them need to be updated due to incompleteness of impurity profiles and obsolescence of analytical methodologies. A case study of metoprolol tartrate and hydrochlorothiazide tablets is presented to summarize challenges encountered during the USP monograph modernization initiative of FDCs and to highlight an "adoption and adaptation" approach employed for method development. To this end, a single stability-indicating HPLC method was developed to separate the two drug substances and eight related compounds with resolution 2.0 or higher between all critical pairs. Chromatographic separations were achieved on a Symmetry column(C18,100 mm*4.6 mm, 3.5 mm) using sodium phosphate buffer(pH 3.0; 34 mM) and acetonitrile as mobile phase in a gradient elution mode. The stability-indicating capability of this method has been demonstrated by analyzing stressed samples of the two drug substances. The developed HPLC method was validated for simultaneous determination of metoprolol tartrate and hydrochlorothiazide and relevant impurities in the tablets. Moreover, the developed method was successfully applied to the analysis of commercial tablet dosage forms and proved to be suitable for routine quality control use. The case study could be used to streamline USP's monograph modernization process of FDCs and strengthen compendial procedures.展开更多
Objective:To explore the effect of metoprolol succinate sustained-release tablets combined with Wenxin Granules in the treatment of coronary heart disease patients with arrhythmia.Methods:The research objects were 50 ...Objective:To explore the effect of metoprolol succinate sustained-release tablets combined with Wenxin Granules in the treatment of coronary heart disease patients with arrhythmia.Methods:The research objects were 50 patients with arrhythmia who were treated in our hospital from September 2019 to September 2020.According to different treatment methods,they were divided into observation group(Wenxin Granule+metoprolol succinate treatment)and control group(metoprolol succinate treatment),25 cases in each group.The curative effects of the two groups were compared.Results:After treatment,there was no significant difference in rnn50,RMSSD,sdnni and SDANN between the two groups(P>0.05).Compared with the control group,the SDNN in the observation group was higher than that in the control group(P<0.05);Before treatment,there was no significant difference in the above indexes between the two groups(P>0.05);The effective rates of the observation group and the control group were 92.00%and 68.00%respectively,and the curative effect of the observation group was higher than that of the control group(P<0.05);There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:In the treatment of patients with coronary heart disease and arrhythmia,Wenxin Granule Combined with metoprolol succinate sustained-release tablets has significant effect,which can effectively improve the dynamic electrocardiogram indexes of patients,improve the clinical efficacy,and has high safety.展开更多
目的研究酒石酸美托洛尔对主动脉瓣置换术(Aortic valve replacement,AVR)后患者心率变异性(Heart rate variability,HRV)的影响。方法收集2020-2023年北部战区总医院心血管外科收治的因主动脉瓣病变在全身麻醉下进行AVR术的109例患者...目的研究酒石酸美托洛尔对主动脉瓣置换术(Aortic valve replacement,AVR)后患者心率变异性(Heart rate variability,HRV)的影响。方法收集2020-2023年北部战区总医院心血管外科收治的因主动脉瓣病变在全身麻醉下进行AVR术的109例患者的资料,回顾性分析患者术后使用酒石酸美托洛尔的情况。将患者分为A、B、C 3组,其中A组为术后未使用酒石酸美托洛尔(n=26),B组为按需给药(患者术后窦性心率加快,患者主诉心悸,心率大于85次/min,临时给予酒石酸美托洛尔25 mg,术后住院期间总给予剂量小于200 mg,n=35),C组为常规按疗程给药(术后按常规给予酒石酸美托洛尔,25 mg,2次/d,当患者心率小于50次/min时停用,术后住院期间总给予剂量大于200 mg,n=48)。分别收集三组患者术后HRV指标,包括窦性心搏RR间期标准差(Standard deviation of NN intervals,SDNN)、窦性RR间期均值标准差(Standard deviation of the averages of NN intervals for each 5-minutes,SDANN)及一般临床资料。结果三组术前1周及术后1周左室射血分数(Left ventricular ejection fraction,LVEF)、左室舒张末期内径、左室后壁厚度、室间隔厚度及左房内径比较,差异均无统计学意义(P>0.05)。三组术前1周SDNN及SDANN比较,差异均无统计学意义(P>0.05)。术后1周SDANN:B组(57.782±17.690)ms与C组(60.207±10.756)ms高于A组(52.917±11.777)ms,C组高于B组,差异具有统计学意义(P<0.05);术后1周SDNN:B组(57.048±10.759)ms与C组(66.136±19.324)ms高于A组(50.357±11.794)ms,C组高于B组,差异具有统计学意义(P<0.05)。结论AVR术后早期应用酒石酸美托洛尔,对HRV有积极作用,在维持心脏自主神经功能稳态上,酒石酸美托洛尔按常规给药比按需给药体现出显著优势,推荐临床中按剂量使用酒石散美托洛尔,以促进术后自主神经功能的恢复稳定。展开更多
文摘The current United States Pharmacopeia–National Formulary(USP–NF) includes more than 250 monographs of fixed dose combinations(FDCs), and some of them need to be updated due to incompleteness of impurity profiles and obsolescence of analytical methodologies. A case study of metoprolol tartrate and hydrochlorothiazide tablets is presented to summarize challenges encountered during the USP monograph modernization initiative of FDCs and to highlight an "adoption and adaptation" approach employed for method development. To this end, a single stability-indicating HPLC method was developed to separate the two drug substances and eight related compounds with resolution 2.0 or higher between all critical pairs. Chromatographic separations were achieved on a Symmetry column(C18,100 mm*4.6 mm, 3.5 mm) using sodium phosphate buffer(pH 3.0; 34 mM) and acetonitrile as mobile phase in a gradient elution mode. The stability-indicating capability of this method has been demonstrated by analyzing stressed samples of the two drug substances. The developed HPLC method was validated for simultaneous determination of metoprolol tartrate and hydrochlorothiazide and relevant impurities in the tablets. Moreover, the developed method was successfully applied to the analysis of commercial tablet dosage forms and proved to be suitable for routine quality control use. The case study could be used to streamline USP's monograph modernization process of FDCs and strengthen compendial procedures.
文摘Objective:To explore the effect of metoprolol succinate sustained-release tablets combined with Wenxin Granules in the treatment of coronary heart disease patients with arrhythmia.Methods:The research objects were 50 patients with arrhythmia who were treated in our hospital from September 2019 to September 2020.According to different treatment methods,they were divided into observation group(Wenxin Granule+metoprolol succinate treatment)and control group(metoprolol succinate treatment),25 cases in each group.The curative effects of the two groups were compared.Results:After treatment,there was no significant difference in rnn50,RMSSD,sdnni and SDANN between the two groups(P>0.05).Compared with the control group,the SDNN in the observation group was higher than that in the control group(P<0.05);Before treatment,there was no significant difference in the above indexes between the two groups(P>0.05);The effective rates of the observation group and the control group were 92.00%and 68.00%respectively,and the curative effect of the observation group was higher than that of the control group(P<0.05);There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:In the treatment of patients with coronary heart disease and arrhythmia,Wenxin Granule Combined with metoprolol succinate sustained-release tablets has significant effect,which can effectively improve the dynamic electrocardiogram indexes of patients,improve the clinical efficacy,and has high safety.
文摘目的研究酒石酸美托洛尔对主动脉瓣置换术(Aortic valve replacement,AVR)后患者心率变异性(Heart rate variability,HRV)的影响。方法收集2020-2023年北部战区总医院心血管外科收治的因主动脉瓣病变在全身麻醉下进行AVR术的109例患者的资料,回顾性分析患者术后使用酒石酸美托洛尔的情况。将患者分为A、B、C 3组,其中A组为术后未使用酒石酸美托洛尔(n=26),B组为按需给药(患者术后窦性心率加快,患者主诉心悸,心率大于85次/min,临时给予酒石酸美托洛尔25 mg,术后住院期间总给予剂量小于200 mg,n=35),C组为常规按疗程给药(术后按常规给予酒石酸美托洛尔,25 mg,2次/d,当患者心率小于50次/min时停用,术后住院期间总给予剂量大于200 mg,n=48)。分别收集三组患者术后HRV指标,包括窦性心搏RR间期标准差(Standard deviation of NN intervals,SDNN)、窦性RR间期均值标准差(Standard deviation of the averages of NN intervals for each 5-minutes,SDANN)及一般临床资料。结果三组术前1周及术后1周左室射血分数(Left ventricular ejection fraction,LVEF)、左室舒张末期内径、左室后壁厚度、室间隔厚度及左房内径比较,差异均无统计学意义(P>0.05)。三组术前1周SDNN及SDANN比较,差异均无统计学意义(P>0.05)。术后1周SDANN:B组(57.782±17.690)ms与C组(60.207±10.756)ms高于A组(52.917±11.777)ms,C组高于B组,差异具有统计学意义(P<0.05);术后1周SDNN:B组(57.048±10.759)ms与C组(66.136±19.324)ms高于A组(50.357±11.794)ms,C组高于B组,差异具有统计学意义(P<0.05)。结论AVR术后早期应用酒石酸美托洛尔,对HRV有积极作用,在维持心脏自主神经功能稳态上,酒石酸美托洛尔按常规给药比按需给药体现出显著优势,推荐临床中按剂量使用酒石散美托洛尔,以促进术后自主神经功能的恢复稳定。
