目的 制备一种盐酸哌甲酯(MPH)缓释微丸胶囊剂,并与进口控释片专注达?体外释放情况进行比较研究。 方法 利用流化床包衣技术制备一种含有3种不同释药速率微丸的MPH缓释微丸胶囊剂:将部分载药微丸包保护层后制成速释微丸;以乙基纤维素(Surelease?)为缓释材料制备单层缓释微丸;通过内包溶胀层(欧巴代-7006,主成分为低黏度羟丙基甲基纤维素(HPMC),外加控释层制备具有时滞的双层择时缓释微丸。在模拟胃肠道pH值介质中比较自制胶囊剂与控释片的体外释药情况。 结果 载药微丸实际载药量6.85%。单层缓释微丸包衣增重14%;双层择时缓释微丸溶胀层包衣增重16%,控释层包衣增重22%,时滞约3.5 h。3种微丸按以下比例混合后装胶囊:速释微丸含MPH 22%,单层缓释微丸含MPH 39%,双层择时缓释微丸含MPH 39%。该胶囊剂1 h释放可达25%,4 h释放约50%,12 h释放>95%。两制剂在模拟胃肠道介质中的释放曲线相似。 结论 制备出一种由3种微丸组成的,能连续12 h释药的MPH缓释微丸胶囊剂,其工艺简单,与进口控释片专注达?有相同的体外释放效果。
ObjectiveTo observe the effect of sensory integration training combined with methylphenidate hydrochloride on attention deficit hyperactivity disorder (ADHD). MethodsThe clinical data of 96 patients with ADHD diagnosed between January 2009 and March 2013 were retrospectively analyzed. The patients were divided into two groups by the table of random number. The trail group (n=48) received the combination therapy of sensory integration training combined with methylphenidate hydrochloride; while the control group (n=48) only received the medication of methylphenidate hydrochloride. The scores of sensory integration ability rating scale, integrated visual and auditory continuous performance test (IVA-CPT), Conner's behavior rating scale, Chinese Wechsler Intelligence Scale for Children (C-WISC) and adverse reactions were observed and compared between the two groups. ResultsThe scores of the sensory integration ability rating scale, FRCQ, FAQ (IVA-CPT), PIQ, VIQ, FIQ, C factor (C-WISC) in both of the two groups were significantly higher after the therapy; while the scores of the study, behavior, somatopsychic disturbance, impulsion, hyperactivity index and anxiety factor significantly decreased after the treatment (P<0.05). Compared with the control group, the trial group's scores of sensory integration ability rating scale, IVA-CPT, Conner's behavior rating scale, C-WISC were improved obviously, and the adverse reactions were significantly less (P<0.05). ConclusionThe sensory integration training combined with methylphenidate hydrochloride is sage and effective on children with attention deficit hyperactivity disorder.