摘要：Objectives: To assess the efficacy of combining unprotected powder enzymes an d oral enteric- coated microsphere (ECM) and to ECM alone in treating nutrient maldigestion in patients with cystic fibrosis. Study design: Patients were rando mly assigned into 2 consecutive, 2- week phases; ECM alone, and ECM plus unprot ected powder enzymes. Fecal fat, energy, and nitrogen output were compared with intake at the end of each phase. Two- tailed, paired t tests were performed to compare outcomes. Results: The mean age of the 14 patients (3 girls) was 5.7 ± 3.2 years (range, 1.9 to 13.4 years). There was no significant difference in pe rcent malabsorption of fat (15.6% vs 18.2% ), energy (13.3% vs 13.4% ), or nitrogen (11.8% vs 11.3% ) between phases. Conclusions: The addition of powd er enzymes to ECM did not improve nutrient maldigestion compared with ECM alone.

摘要：目的:研究肠溶衣对吲哚美辛肠溶片含量测定的影响。方法:采用紫外分光光度法,并进行配对设计的t检验。结果:肠溶衣溶液在 310～340 nm范围内无吸收。P>0.05(n=5)。差别无显著性意义。结论:肠溶衣对吲哚美辛肠溶片的含量测定无干扰,可不除肠溶衣进行该片的含量测定。

摘要：目的:研究肠溶衣对双氯芬酸钠片含量测定的影响。方法:采用紫外分光光度法,并进行配对设计的t检验。结果:肠溶衣溶液在200～400nm波长范围内无吸收,平均回收率为99.63%n=5,RSD为0.53%,P>0.05n=4,差别无显著性意义。结论:肠溶衣对双氯芬酸钠肠溶衣片的含量测定无干扰,可不除肠溶衣直接测定双氯芬酸钠片的含量。

摘要：目的制备三七总皂苷(PNS)肠溶缓释片,考察其体外释放度。方法以辅料羟丙基甲基纤维素(HPMC_(K15M))和微晶纤维素(MCC)的用量为自变量,以药物累积释放度总评分为因变量,采用中心复合设计-效应面法,优选PNS缓释片的最佳工艺参数;以羟丙基甲基纤维素酸酞酯(HPMCP)为肠溶衣材料,采用单因素法考察包肠溶衣过程。结果最佳工艺参数为:PNS∶HPMC _(K15M)∶MCC用量比为∶100∶51∶92,片芯:HPMCP为100∶8,压片数量1000片,每片0.26 g,此条件药物累积释放度综合评分为97.74,与理论预测值基本吻合。结论优化工艺稳定、可行,具有一定的应用价值。

摘要：片剂是目前世界各国药典收载最多的剂型之一,也是国内外临床治疗中使用得最为广泛的剂型之一。为了保证和提高片剂的治疗效果,各国药典对收载的片剂均有严格的质量规定。优质的片剂一般要求主药含量准确,重量差异小;质量稳定,色泽均匀。