Sofosbuvir is one of the new direct-acting antiviral drugs against hepatitis C virus(HCV) infection. This drug has recently been launched into the market, and generic versions of the medication are expected to be prod...Sofosbuvir is one of the new direct-acting antiviral drugs against hepatitis C virus(HCV) infection. This drug has recently been launched into the market, and generic versions of the medication are expected to be produced by local drug producers in some countries. Therefore, new methods are required to control sofosbuvir in pharmaceuticals. In the present study, a new method based on reversed phase(RP)-ultra-high performance liquid chromatography(UHPLC) coupled to diode array detection(DAD) and mass spectrometry(MS) was developed to facilitate the qualitative and quantitative analysis of sofosbuvir in film coated tablets. A wavelength of 260 nm was selected to perform a cost-effective quantification and the method showed adequate linearity,with an R^2 value of 0.9998, and acceptable values of accuracy(75%–102%) and precision(residual standard deviation < 5%). The detection and quantification limits were 0.07 μg/mL and 0.36 μg/mL, respectively.Furthermore, the use of high-resolution MS enabled us to ensure the specificity, check impurities and better sensitivity. Therefore, this methodology promises to be suitable not only for the routine analysis of sofosbuvir in pharmaceutical dosage forms, but also for potential degradants.展开更多
目的探讨孟鲁司特钠口溶膜与咀嚼片在过敏性鼻炎患儿中的应用效果及安全性。方法将2022年4—12月十堰市太和医院收治的80例过敏性鼻炎患儿根据随机数字表法分为两组。对照组40例患儿采用孟鲁司特钠咀嚼片进行治疗,观察组40例患儿则采用...目的探讨孟鲁司特钠口溶膜与咀嚼片在过敏性鼻炎患儿中的应用效果及安全性。方法将2022年4—12月十堰市太和医院收治的80例过敏性鼻炎患儿根据随机数字表法分为两组。对照组40例患儿采用孟鲁司特钠咀嚼片进行治疗,观察组40例患儿则采用孟鲁司特钠口溶膜进行治疗。将两组过敏性鼻炎治疗总有效率、不良情况发生率、不良反应发生率、治疗前后的变态反应指标[血清特异性IgE(serum specific IgE,SIgE)及嗜酸粒细胞阳离子蛋白(eosinophil cationic protein,ECP)]、治疗依从性(Morisky用药依从性问卷)及生存质量(少年儿童慢性鼻窦炎患者生活质量量表评分)进行比较。结果两组过敏性鼻炎治疗总有效率及不良反应总发生率比较,差异无统计学意义(P>0.05);观察组不良情况总发生率低于对照组(P<0.05);治疗前两组的变态反应指标、Morisky用药依从性及少年儿童慢性鼻窦炎患者生活质量量表评分比较,差异无统计学意义(P>0.05);治疗3周后观察组的变态反应指标低于对照组,Morisky用药依从性及少年儿童慢性鼻窦炎患者生活质量量表评分优于对照组(P<0.05)。结论鲁司特钠口溶膜在过敏性鼻炎患儿中的应用效果值得肯定,安全性更为优于咀嚼片,且患儿的治疗依从性相对更高,因此在过敏性鼻炎患儿中的应用价值较高。展开更多
基金the postdoctoral grant associated to the Excellence Project P11-CTS-7625, which was also financed by the previous entity
文摘Sofosbuvir is one of the new direct-acting antiviral drugs against hepatitis C virus(HCV) infection. This drug has recently been launched into the market, and generic versions of the medication are expected to be produced by local drug producers in some countries. Therefore, new methods are required to control sofosbuvir in pharmaceuticals. In the present study, a new method based on reversed phase(RP)-ultra-high performance liquid chromatography(UHPLC) coupled to diode array detection(DAD) and mass spectrometry(MS) was developed to facilitate the qualitative and quantitative analysis of sofosbuvir in film coated tablets. A wavelength of 260 nm was selected to perform a cost-effective quantification and the method showed adequate linearity,with an R^2 value of 0.9998, and acceptable values of accuracy(75%–102%) and precision(residual standard deviation < 5%). The detection and quantification limits were 0.07 μg/mL and 0.36 μg/mL, respectively.Furthermore, the use of high-resolution MS enabled us to ensure the specificity, check impurities and better sensitivity. Therefore, this methodology promises to be suitable not only for the routine analysis of sofosbuvir in pharmaceutical dosage forms, but also for potential degradants.
文摘目的探讨孟鲁司特钠口溶膜与咀嚼片在过敏性鼻炎患儿中的应用效果及安全性。方法将2022年4—12月十堰市太和医院收治的80例过敏性鼻炎患儿根据随机数字表法分为两组。对照组40例患儿采用孟鲁司特钠咀嚼片进行治疗,观察组40例患儿则采用孟鲁司特钠口溶膜进行治疗。将两组过敏性鼻炎治疗总有效率、不良情况发生率、不良反应发生率、治疗前后的变态反应指标[血清特异性IgE(serum specific IgE,SIgE)及嗜酸粒细胞阳离子蛋白(eosinophil cationic protein,ECP)]、治疗依从性(Morisky用药依从性问卷)及生存质量(少年儿童慢性鼻窦炎患者生活质量量表评分)进行比较。结果两组过敏性鼻炎治疗总有效率及不良反应总发生率比较,差异无统计学意义(P>0.05);观察组不良情况总发生率低于对照组(P<0.05);治疗前两组的变态反应指标、Morisky用药依从性及少年儿童慢性鼻窦炎患者生活质量量表评分比较,差异无统计学意义(P>0.05);治疗3周后观察组的变态反应指标低于对照组,Morisky用药依从性及少年儿童慢性鼻窦炎患者生活质量量表评分优于对照组(P<0.05)。结论鲁司特钠口溶膜在过敏性鼻炎患儿中的应用效果值得肯定,安全性更为优于咀嚼片,且患儿的治疗依从性相对更高,因此在过敏性鼻炎患儿中的应用价值较高。
