氯霉素耳用滴丸的制备工艺研究.pdfVIP

安 徽 医 药 　A nhu iM ed ica l and P ha rm aceu tica l J ou rna l　2005 M ar; 9 ( 3) 1·67 · ◇药学研究 ◇ 氯霉素耳用滴丸的制备工艺研究 苏春梅 ,梁翠茵 ,张 　念 ,杨 　红 ,李 　琳 (首都医科大学顺义校区 ,北京 　101300) 摘要 : 目的　以水溶性高分子材料 PEG6000为基质 ,研究氯霉素耳用滴丸的最佳制备工艺 。方法 　通过对氯霉素耳用滴丸制 备过程的实验 , 以滴丸的成型 ,圆整度 ,重量差异为筛选指标 , 以药液的保温温度 、滴制速度 、药物与基质的最佳配比为主要考察 因素 ,对氯霉素耳用滴丸的制备工艺进行优选 。并讨论了影响滴丸成型 ,圆整度及丸重差异的其他因素 。结果 　药物与基质的 最佳配比为 1 ∶3、药液温度为 80 ～90 ℃、滴制速度为 50 滴 /分 ,为最佳制备工艺条件 。按照此优化条件制备的氯霉素耳用滴丸 成型率最高 。结论 　此制备工艺设备简单 ,操作方便 ,不仅适合于氯霉素耳用滴丸的制备 ,也同样适合于其他滴丸产品的实验 室制备及工业化生产 。 关键词 :氯霉素耳用滴丸 ;成型 ; 圆整度 ;重量差异 Study on prepara tion of chloram phen icol otic drop p ills SU Chunm ei , L IAN G Cu iyin , ZHAN G N ian , YAN G Hong , L I L in (S huny i B ranch of Cap ita l Un iversity of M ed ica l S ciences, B eij ing　101300, Ch ina) A b stract:A im 　To study the techno logical p aram eters of the ch loramphen icol otic drop p ills in u sing the PEG6000 a sm atrics. M ethods 　The p roce ss wa s studied by a series of tests w ith the form ation s, the round and the weight deviation of otic drop p ills as the cvaluation quota to decide the be st dropp ing condition, and the three factors were the temp eratu re of m ixtu re, the dropp ing sp eed of drop p ills and the formu lation ingredien ts . The form ation and roundue ss of p ills a s well as their weight deviation are discu ssed. Results　The resu lts showed that in order to get the h ighe st mou lding p robab ility of the Ch loramp hen ico l otic drop p ills, the op tim al p roce ss wa s that the Ch loramphen ico l otic drop p ills shou ld be dropp ed into the m ixture of 80 ～90 ℃ by 50 dropp ing p er m inu te w ith the form u lation ingredi en ts of 1 ∶3. Con clusion s　Th is p rep aration m ethod is simp le, conven ien t and can be con tro ll