【作者】 刘逆夫；

【导师】 康仕芳；

【作者基本信息】 天津大学 ， 制药工程， 2004， 硕士

【摘要】 雷公藤内酯甲是雷公藤多甙的主要活性成分之一，同时又是其指示成分。雷公藤多甙片新的质量标准要求测定雷公藤内酯甲的含量，检测过程中要求用纯雷公藤内酯甲作对照，由于其价格昂贵且不易购买，迫切需要提取分离高纯度的雷公藤内酯甲。柱层析是雷公藤多甙生产的关键工序，本研究对该工序的生产数据进行了分析，发现现有生产工艺存在下列问题：a 收率低；b 工序处于未受控状态；c 有雷公藤内酯甲含量低的不合格品产生。 针对上述问题，通过查阅大量的文献资料，根据雷公藤内酯甲的性质，进行了展开剂的预选，找出从该工序废液中分离提纯雷公藤内酯甲的新的工艺路线，分离提纯出来的物质经结构鉴定确认为雷公藤内酯甲。本研究还对雷公藤多甙生产中柱层析工序进行了优化，改进后的工艺，经 11 批生产验证，达到了良好的效果：收率提高了 35.5％，不合格率下降到零，工序质量处于受控状态。 本研究结果应用于实际生产给工厂带来了良好的经济效益，由于收率的提高，当年 11 批产品共增产 26.77kg，创效益 133.85 万元。另外，由于工序的稳定，减少了不合格品带来的损失。更多还原

【Abstract】 Wilforlide A is Leigongteng Duodai’s characteristic and active constituent. It is ruled innew quality standard of Leigongteng Duodai tablets that the concentration of Wilforlide Amustbe determined, and it is needed to check analysis with pure Wilforlide A in the determinationprocedure. Until now, it is difficult to purchase pure Wilforlide A for its high price, so it isessential to search a new method to manufacture pure Wilforlide A. Column chromatographyprocedure is the key process of producing Leigongteng Duodai. After analyzing the productiondata, it is reviewed that there exist following problems in the production procedure: 1. the yieldis too low; 2. process is uncontrollable; 3. there exist unaccepted product on occasion. Based on reading a large mount of references and mastering the character of Wilforlide A,the primary selection of developing agent is done, and a new technology route is found out,which purifies Wilforlide A from the waste liquid produced in the column chromatographyprocedure. After structure identification, the purified substance is proved to be Wilforlide A .Besides, the column chromatography process is improved in this thesis. According to theanalysis results of 11 batches of product, it is verified that the improved technology bringsgood effect. The yield of the procedure has been improved by 35. 5%, unaccepted product ratedrops to zero, and producing process is in the controlled state. This result of study has been applied to production and brings good economic benefits tofactory. 11 batches of products increase production 26 .77 kg and benefit achieve 1 338 500Yuan。 In addition, stability of the process has reduced the loss that unaccepted product brings.更多还原