To develop near-infrared （NIR） reflectance spectroscopic methods for the quantitative analysis of cefoperazone sodium/ sulbactam sodium from different manufacturers for injection powder medicaments. Various powders ...To develop near-infrared （NIR） reflectance spectroscopic methods for the quantitative analysis of cefoperazone sodium/ sulbactam sodium from different manufacturers for injection powder medicaments. Various powders of cefoperazone sodium/ sulbactam sodium were directly analyzed by non-destructive NIR reflectance spectroscopy using the spectrometer EQUINOX55. Two quantitative methods via integrating sphere （IS） and fiberoptic probe （FOP） models were explored from 6 batches of commercial samples and 42 batches of laboratory samples at a content ranging from 30% to 70% for cefoperazone and 60% to 20% for sulbactam. The root mean square errors of cross validation （RMSECV） and the root mean square errors of prediction （RMSEP） of IS were 1.79% and 2.85%, respectively, for cefoperazone sodium, and were 1.86% and 3.08%, respectively, for sulbactam sodium; and those of FOP were 2.93% and 2.92%, respectively, for cefoperazone sodium, and were 2.23% and 3.01%, respectively, for sulbactam sodium. Based on the ICH guidelines and Ref. 12, the quantitative models were then evaluated in terms of specificity, linearity, accuracy, precision, robustness and model transferability. The non-destructive quantitative NIR methods used in this study are applicable for rapid analysis of injectable powdered drugs from different manufacturers.展开更多
目的:观察头孢哌酮钠舒巴坦钠联合参麦注射液治疗老年卒中相关性肺炎(SAP)的疗效和安全性。方法:选择2016年3月-2017年3月达州市中心医院收治的84例SAP患者,按随机数字表法分为对照组(42例)和观察组(42例)。在常规治疗的基础上,对照组...目的:观察头孢哌酮钠舒巴坦钠联合参麦注射液治疗老年卒中相关性肺炎(SAP)的疗效和安全性。方法:选择2016年3月-2017年3月达州市中心医院收治的84例SAP患者,按随机数字表法分为对照组(42例)和观察组(42例)。在常规治疗的基础上,对照组患者给予注射用头孢哌酮钠舒巴坦钠3 g,加入5%葡萄糖注射液100 m L,静脉滴注,每日2次;并依据病原学检查及药敏试验结果选择合适的抗菌药物。观察组患者在对照组治疗的基础上给予参麦注射液100 m L,加入5%葡萄糖注射液250 m L中,静脉滴注,每日1次。两组患者均连续治疗2周。观察两组患者的临床疗效,治疗前后T淋巴细胞亚群(CD4^+、CD8^+、CD4^+/CD8^+)、炎症标志物[血清肿瘤坏死因子α(TNF-α)、超敏C反应蛋白(hs-CRP)、降钙素原(PCT)]水平、住院时间,并记录不良反应发生情况。结果:观察组患者总有效率(95.24%)和显效率(47.62%)均显著高于对照组的83.33%和23.81%,住院时间[(15.24±3.53)d]显著短于对照组[(18.43±4.21)d],差异均有统计学意义(P<0.05)。治疗后,两组患者CD4^+、CD4^+/CD8^+水平均显著高于同组治疗前,且观察组显著高于对照组;两组患者CD8^+、TNF-α、hs-CRP、PCT水平均显著低于同组治疗前,且观察组显著低于对照组,差异均有统计学意义(P<0.05)。两组患者不良反应总发生率比较,差异均无统计学意义(P>0.05)。结论:在常规治疗的基础上,头孢哌酮钠舒巴坦钠联合参麦注射液治疗SAP疗效显著,可有效改善患者免疫功能,降低机体炎症水平,缩短住院时间,且未增加不良反应的发生。展开更多
基金National Key Technologies R&D Program Foundation of China (Grant No. 2006BAK04A11)
文摘To develop near-infrared （NIR） reflectance spectroscopic methods for the quantitative analysis of cefoperazone sodium/ sulbactam sodium from different manufacturers for injection powder medicaments. Various powders of cefoperazone sodium/ sulbactam sodium were directly analyzed by non-destructive NIR reflectance spectroscopy using the spectrometer EQUINOX55. Two quantitative methods via integrating sphere （IS） and fiberoptic probe （FOP） models were explored from 6 batches of commercial samples and 42 batches of laboratory samples at a content ranging from 30% to 70% for cefoperazone and 60% to 20% for sulbactam. The root mean square errors of cross validation （RMSECV） and the root mean square errors of prediction （RMSEP） of IS were 1.79% and 2.85%, respectively, for cefoperazone sodium, and were 1.86% and 3.08%, respectively, for sulbactam sodium; and those of FOP were 2.93% and 2.92%, respectively, for cefoperazone sodium, and were 2.23% and 3.01%, respectively, for sulbactam sodium. Based on the ICH guidelines and Ref. 12, the quantitative models were then evaluated in terms of specificity, linearity, accuracy, precision, robustness and model transferability. The non-destructive quantitative NIR methods used in this study are applicable for rapid analysis of injectable powdered drugs from different manufacturers.
文摘目的:观察头孢哌酮钠舒巴坦钠联合参麦注射液治疗老年卒中相关性肺炎(SAP)的疗效和安全性。方法:选择2016年3月-2017年3月达州市中心医院收治的84例SAP患者,按随机数字表法分为对照组(42例)和观察组(42例)。在常规治疗的基础上,对照组患者给予注射用头孢哌酮钠舒巴坦钠3 g,加入5%葡萄糖注射液100 m L,静脉滴注,每日2次;并依据病原学检查及药敏试验结果选择合适的抗菌药物。观察组患者在对照组治疗的基础上给予参麦注射液100 m L,加入5%葡萄糖注射液250 m L中,静脉滴注,每日1次。两组患者均连续治疗2周。观察两组患者的临床疗效,治疗前后T淋巴细胞亚群(CD4^+、CD8^+、CD4^+/CD8^+)、炎症标志物[血清肿瘤坏死因子α(TNF-α)、超敏C反应蛋白(hs-CRP)、降钙素原(PCT)]水平、住院时间,并记录不良反应发生情况。结果:观察组患者总有效率(95.24%)和显效率(47.62%)均显著高于对照组的83.33%和23.81%,住院时间[(15.24±3.53)d]显著短于对照组[(18.43±4.21)d],差异均有统计学意义(P<0.05)。治疗后,两组患者CD4^+、CD4^+/CD8^+水平均显著高于同组治疗前,且观察组显著高于对照组;两组患者CD8^+、TNF-α、hs-CRP、PCT水平均显著低于同组治疗前,且观察组显著低于对照组,差异均有统计学意义(P<0.05)。两组患者不良反应总发生率比较,差异均无统计学意义(P>0.05)。结论:在常规治疗的基础上,头孢哌酮钠舒巴坦钠联合参麦注射液治疗SAP疗效显著,可有效改善患者免疫功能,降低机体炎症水平,缩短住院时间,且未增加不良反应的发生。
