Studies On Quality Improving In The Leigongteng Duodai's Column Chromatography Procedure

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.