Preparation and evaluation of tamsulosin hydrochloride sustained-release pellets modified by two-layered membrane techniques

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.

盐酸哌甲酯缓释制剂治疗注意缺陷多动障碍儿童临床效果的影响因素研究

目的:探讨注意缺陷多动障碍(ADHD)儿童应用盐酸哌甲酯缓释制剂治疗临床效果的影响因素。方法:选取2018年4月-2019年4月于本院就诊的46例ADHD患儿作为研究对象,均给予盐酸哌甲酯缓释制剂治疗。治疗前采用联合型瑞文测验(CRT)评估患儿智力,并根据国际最新方法将ADHD患儿分为注意力缺陷型、冲动型/多动型和混合型。治疗12周后采用斯诺佩评估量表(SNAP-Ⅳ)由家长进行效果评定。分析性别、年龄、药物剂量、智力水平及不同ADHD分型对临床疗效的影响。结果:性别、年龄对治疗效果的影响比较,差异无统计学意义(P>0.05);小剂量盐酸哌甲酯缓释制剂的治疗效果优于大剂量,差异有统计学意义(P<0.05)。智力水平、不同ADHD分型对治疗效果的影响比较,差异有统计学意义(P<0.05);且智力水平越高,治疗效果越好,治疗显效患儿中,以注意力缺陷型最高,依次是混合型、冲动型/多动型,差异有统计学意义(P<0.05)。结论:盐酸哌甲酯缓释制剂治疗ADHD儿童临床受用药剂量、智力水平、不同ADHD分型因素的影响,临床治疗应最大程度降低相关因素的影响,提高治疗效果,改善患儿预后。

盐酸哌甲酯双相控释渗透泵片的制备工艺研究

目的:研究盐酸哌甲酯双相控释渗透泵片的制备方法和工艺优化。方法:以双层渗透泵缓控释片的制备工艺为基础,结合双相释药行为的原理,制备具有两个不同释放相的双释放制剂。通过对含药层和助推层的单因素考察试验,确定各辅料的用量。对压片及包衣工艺参数进行考察,研究得到最佳压片方法以及最佳包衣参数。结果:制备的盐酸哌甲酯双相控释渗透泵片具有两个不同的释放相,优化处方制得的盐酸哌甲酯双相控释渗透泵片外观合格,含药量重复性好,在体外释药曲线在0~2h内快速释放,2~10h符合零级释放,重复性较好。结论:本制备方法科学、简便、完整,可用于制备盐酸哌甲酯双相控释渗透泵片。