中国药房2016，Vol.27Issue(7)：952-954,955,4.DOI:10.6039/j.issn.1001-0408.2016.07.27
正交试验优选磷酸二甲啡烷片的处方工艺
Optimization of the Formulation of Dimemorfan Phosphate Tablets by Orthogonal Test
摘要
Abstract
OBJECTIVE:To optimize the formulation of Dimemorfan phosphate tablets. METHODS:Using 60 min dissolution rate of dimemorfan phosphate as index,L9(34) orthogonal test was used to optimize the amount of starch,microcrystalline cellu-lose,croscarmellose sodium and concentration of HPMC E5 solution. The friability,hardness,60 min dissolution rate and main component were detected. The similarity of dissolution curves of Dimemorfan phosphate tablets was compared with that of imported tablets in 0.1 mol/L hydrochloric acid,pH 6.8 phosphate buffer,water and pH 4.0 acetate buffer. RESULTS:The optimized formu-lation of Dimemorfan phosphate tablet(1 000 tablets)was composed of dimemorfan phosphate 10 g,starch 60 g,microcrystalline cellulose 40 g,10% HPMC E5 solution and croscarmellose sodium 25 g. The friability,hardness,60 min dissolution rate and main component of 3 batches of Dimemorfan phosphate tablets prepared by optimized prescription were 0.42%-0.58%,9.8-10.5 kg,94.89%-96.21% and 99.21%-99.52%,respectively. In 4 dissolution mediums,similar factors f2 of dissolution curves between prepared tablets and imported tablets were above 50. CONCLUSIONS:Dimemorfan phosphate tablets were prepared successfully. The optimized formulation is rational. The dissolution behavior of prepared tablets is similar to that of imported tablets in vitro.关键词
磷酸二甲啡烷片/溶出度/正交设计/处方优化/相似性Key words
Dimemorfan phosphate tablets/Dissolution rate/Orthogonal design/Formulation optimization/Similarity分类
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郑保根,刘薇芝,任小旦,颜锵,胡汉昆..正交试验优选磷酸二甲啡烷片的处方工艺[J].中国药房,2016,27(7):952-954,955,4.基金项目
2013年湖北省重大科技创新计划项目 （）
