原料药企业制剂一体化发展路径研究

本文分析我国原料药企业深化制剂一体化发展的可行性。并选取印度阿拉宾度制药有限公司为案例研究对象,对公司制剂一体化历程进行分析,总结其制剂一体化成功经验,最后提出相关建议,以期为我国原料药企业的转型升级提供经验借鉴。

One Step Preparation of Sulfonated Solid Catalyst and Its Effect in Esterification Reaction

A carbon-based sulfonated catalyst was prepared by direct sulfonation and carbonization （in moderate conditions：200 ＆#176;C, 12 h） of red liquor solids, a by-product of paper-making process. The prepared sulfonated cata-lyst （SC） had aromatic structure, composed of carbon enriched inner core, and oxygen-containing （SO3H, COOH, OH） groups enriched surface. The SO3H, COOH, OH groups amounted to 0.74 mmol·g^-1, 0.78 mmol·g^-1, 2.18 mmol·g^-1, respectively. The fresh SC showed much higher catalytic activity than that of the traditional solid acid catalysts （strong^-acid 732 cation exchange resin, hydrogen type zeolite socony mobile-five （HZSM-5）, sulfated zir-conia） in esterification of oleic acid. SC was deactivated during the reactions, through the mechanisms of leaching of sulfonated species and formation of sulfonate esters. Two regeneration methods were developed, and the catalytic activity can be mostly regenerated by regeneration Method 1 and be fully regenerated by regeneration Method 2, respectively.

原料药研发现状与发展趋势

我国是全球第一大原料药生产国和出口国,但原料药行业发展面临着环保、监管等诸多压力。近期发改委和工信部公布了《关于推动原料药产业高质量发展实施方案的通知》,重点明确了“提升新品,高效益商品比例,促进原料药生产制造产业化,规模化发展趋势”,意味着我国原料药高污染、高耗能、低附加值的时代将成为过去,后续行业集中度将不断提升。基于此,文章主要探讨了原料药研发现状与发展趋势。