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
目的探讨盐酸坦索罗辛缓释胶囊联合黄莪胶囊对慢性前列腺炎患者性功能指标的影响。方法选取2022年7月至2023年10月于湖州市中心医院泌尿外科就诊的60例慢性前列腺炎患者,根据随机数字表法分为对照组(采用盐酸坦索罗辛缓释胶囊治疗)及治...目的探讨盐酸坦索罗辛缓释胶囊联合黄莪胶囊对慢性前列腺炎患者性功能指标的影响。方法选取2022年7月至2023年10月于湖州市中心医院泌尿外科就诊的60例慢性前列腺炎患者,根据随机数字表法分为对照组(采用盐酸坦索罗辛缓释胶囊治疗)及治疗组(采用盐酸坦索罗辛缓释胶囊联合黄莪胶囊治疗),每组30例。比较两组患者的慢性前列腺炎症状评分、排尿指标、性激素水平、勃起功能、早泄严重程度及临床疗效。结果治疗前两组患者的美国国立卫生研究院慢性前列腺炎症状指数(National Institute of Health-chronic prostatitis symptom index,NIH-CPSI)、排尿指标、性激素水平、国际勃起功能指数-5(international index of erectilefunction-5,IIEF-5)及中国早泄患者性功能评价表-5(Chinese index of sexual function for premature ejaculation-5,CIPE-5)比较,差异无统计学意义(P>0.05);与对照组比较治疗后,治疗组患者的NIH-CPSI评分、雌二醇水平下降,排尿指标改善,睾酮水平、IIEF-5、CIPE-5评分升高,差异有统计学意义(P<0.05)。治疗组患者的有效率(96.67%)高于对照组(73.33%),差异有统计学意义(P<0.05)。结论盐酸坦索罗辛缓释胶囊联合黄莪胶囊不仅可显著减轻慢性前列腺炎患者的前列腺炎症状,改善排尿功能,还可调节患者的性激素水平,减轻勃起功能障碍和早泄的严重程度。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.
文摘目的探讨盐酸坦索罗辛缓释胶囊联合黄莪胶囊对慢性前列腺炎患者性功能指标的影响。方法选取2022年7月至2023年10月于湖州市中心医院泌尿外科就诊的60例慢性前列腺炎患者,根据随机数字表法分为对照组(采用盐酸坦索罗辛缓释胶囊治疗)及治疗组(采用盐酸坦索罗辛缓释胶囊联合黄莪胶囊治疗),每组30例。比较两组患者的慢性前列腺炎症状评分、排尿指标、性激素水平、勃起功能、早泄严重程度及临床疗效。结果治疗前两组患者的美国国立卫生研究院慢性前列腺炎症状指数(National Institute of Health-chronic prostatitis symptom index,NIH-CPSI)、排尿指标、性激素水平、国际勃起功能指数-5(international index of erectilefunction-5,IIEF-5)及中国早泄患者性功能评价表-5(Chinese index of sexual function for premature ejaculation-5,CIPE-5)比较,差异无统计学意义(P>0.05);与对照组比较治疗后,治疗组患者的NIH-CPSI评分、雌二醇水平下降,排尿指标改善,睾酮水平、IIEF-5、CIPE-5评分升高,差异有统计学意义(P<0.05)。治疗组患者的有效率(96.67%)高于对照组(73.33%),差异有统计学意义(P<0.05)。结论盐酸坦索罗辛缓释胶囊联合黄莪胶囊不仅可显著减轻慢性前列腺炎患者的前列腺炎症状,改善排尿功能,还可调节患者的性激素水平,减轻勃起功能障碍和早泄的严重程度。
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。