The aim of the present study was to develop tamsulosin hydrochloride sustained-release pellets using two-layered membrane techniques.Centrifugal granulator and fluidizedbed coater were employed to prepare drug-loaded ...The aim of the present study was to develop tamsulosin hydrochloride sustained-release pellets using two-layered membrane techniques.Centrifugal granulator and fluidizedbed coater were employed to prepare drug-loaded pellets and to employ two-layered membrane coating respectively.The prepared pellets were evaluated for physicochemical characterization,subjected to differential scanning calorimetry(DSC)and in vitro release of different pH.Different release models and scanning electron microscopy(SEM)were utilized to analyze the release mechanism of Harnual■ and home-made pellets.By comparing the dissolution profiles,the ratio and coating weight gain of Eudragit■ NE30D and Eudragit■ L30D55 which constitute the inside membrane were identified as 18:1 and 10%-11%.The coating amount of outside membrane containing Eudragit■ L30D55 was determined to be 0.8%.The similarity factors(f_(2))of home-made capsule and commercially available product(Harnual■)were above 50 in different dissolution media.DSC studies confirmed that drug and excipients had good compatibility and SEM photographs showed the similarities and differences of coating surface between Harnual■ and self-made pellets before and after dissolution.According to Ritger-Peppas model,the two dosage form had different release mechanism.展开更多
目的分析输尿管结石碎石术后运用盐酸坦索罗辛缓释胶囊、双石通淋胶囊联合辅助排石的效果及对炎症因子的影响。方法120例输尿管结石碎石术后患者,通过随机数字表法分为对照组和观察组,每组60例。对照组采取盐酸坦索罗辛缓释胶囊治疗,观...目的分析输尿管结石碎石术后运用盐酸坦索罗辛缓释胶囊、双石通淋胶囊联合辅助排石的效果及对炎症因子的影响。方法120例输尿管结石碎石术后患者,通过随机数字表法分为对照组和观察组,每组60例。对照组采取盐酸坦索罗辛缓释胶囊治疗,观察组采用盐酸坦索罗辛缓释胶囊+双石通淋胶囊治疗。比较两组临床疗效、用药不良反应发生率及治疗前后炎症因子[C反应蛋白(CRP)、白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)]、疼痛感变化情况。结果与对照组相比,观察组治疗总有效率(95.00%VS 81.67%)更高(P<0.05)。治疗后,对照组和观察组CRP、IL-6、TNF-α均低于治疗前,且与对照组相比,观察组CRP(2.84±0.81 VS 5.36±1.21)mg/L、IL-6(97.79±0.33 VS 122.16±13.57)pg/ml、TNF-α(4.31±1.19 VS 6.44±1.31)μg/L均更低(P<0.05)。治疗后,对照组和观察组视觉模拟评分法(VAS)评分均低于治疗前,且与对照组相比,观察组VAS评分(1.86±0.24 VS 3.58±0.89)分更低(P<0.05)。与对照组相比,观察组用药不良反应发生率(6.67%VS 21.67%)更低(P<0.05)。结论对输尿管结石碎石术后患者采取盐酸坦索罗辛缓释胶囊、双石通淋胶囊联合治疗,可起到辅助排石作用,降低炎症相关因子表达水平,减轻术后疼痛感,且用药不良反应发生率较低,临床安全性、有效性较高,值得推荐。展开更多
文摘The aim of the present study was to develop tamsulosin hydrochloride sustained-release pellets using two-layered membrane techniques.Centrifugal granulator and fluidizedbed coater were employed to prepare drug-loaded pellets and to employ two-layered membrane coating respectively.The prepared pellets were evaluated for physicochemical characterization,subjected to differential scanning calorimetry(DSC)and in vitro release of different pH.Different release models and scanning electron microscopy(SEM)were utilized to analyze the release mechanism of Harnual■ and home-made pellets.By comparing the dissolution profiles,the ratio and coating weight gain of Eudragit■ NE30D and Eudragit■ L30D55 which constitute the inside membrane were identified as 18:1 and 10%-11%.The coating amount of outside membrane containing Eudragit■ L30D55 was determined to be 0.8%.The similarity factors(f_(2))of home-made capsule and commercially available product(Harnual■)were above 50 in different dissolution media.DSC studies confirmed that drug and excipients had good compatibility and SEM photographs showed the similarities and differences of coating surface between Harnual■ and self-made pellets before and after dissolution.According to Ritger-Peppas model,the two dosage form had different release mechanism.
文摘目的分析输尿管结石碎石术后运用盐酸坦索罗辛缓释胶囊、双石通淋胶囊联合辅助排石的效果及对炎症因子的影响。方法120例输尿管结石碎石术后患者,通过随机数字表法分为对照组和观察组,每组60例。对照组采取盐酸坦索罗辛缓释胶囊治疗,观察组采用盐酸坦索罗辛缓释胶囊+双石通淋胶囊治疗。比较两组临床疗效、用药不良反应发生率及治疗前后炎症因子[C反应蛋白(CRP)、白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)]、疼痛感变化情况。结果与对照组相比,观察组治疗总有效率(95.00%VS 81.67%)更高(P<0.05)。治疗后,对照组和观察组CRP、IL-6、TNF-α均低于治疗前,且与对照组相比,观察组CRP(2.84±0.81 VS 5.36±1.21)mg/L、IL-6(97.79±0.33 VS 122.16±13.57)pg/ml、TNF-α(4.31±1.19 VS 6.44±1.31)μg/L均更低(P<0.05)。治疗后,对照组和观察组视觉模拟评分法(VAS)评分均低于治疗前,且与对照组相比,观察组VAS评分(1.86±0.24 VS 3.58±0.89)分更低(P<0.05)。与对照组相比,观察组用药不良反应发生率(6.67%VS 21.67%)更低(P<0.05)。结论对输尿管结石碎石术后患者采取盐酸坦索罗辛缓释胶囊、双石通淋胶囊联合治疗,可起到辅助排石作用,降低炎症相关因子表达水平,减轻术后疼痛感,且用药不良反应发生率较低,临床安全性、有效性较高,值得推荐。
