痛安注射液青风藤中间体纯化工艺研究  

Investigation on Purification Process of Intermediate Product of Caulis Sinomenii from Tong-An Injection

作　　者：康小东[1,2] 杨绪芳[1,2] 李峰[1,2] 刘俊超[1,2] 吴云[1,2] 孙永成[1,2] 萧伟[1,2] 

机构地区：[1]江苏康缘药业股份有限公司,连云港222001 [2]中药制药过程新技术国家重点实验室,连云港222001

出　　处：《世界科学技术-中医药现代化》2015年第5期1090-1094,共5页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科学技术部重大新药创制项目(2013ZX09402203):现代中药创新集群与数字制药技术平;负责人:王振中

摘　　要：目的:为了提高青风藤中间体中青藤碱的转移率,优化了痛安注射液青风藤中间体的纯化工艺。方法:以青藤碱转移率及青风藤中间体指纹图谱稳定性为指标,考察萃取过程中药液不同p H值对青藤碱转移率的影响;以青藤碱转移率为指标,考察酸水溶解过程中不同p H值盐酸酸水液对溶解效果的影响;以青藤碱转移率为指标,分别考察减压抽滤、板框式过滤器、高速管式分离机、平板直联式离心机等四种分离方式对青风藤酸水溶解液分离效果的影响。结果:萃取前青风藤药液p H值为10-11时,青藤碱在萃取过程中转移率最高并且制备得到的痛安注射液成品指纹图谱稳定性好;酸溶过程中盐酸酸水溶液p H值范围为2.0-2.5时,青藤碱转移率最高,为92.94%;高速管式分离方式对青风藤酸水溶解液分离效果最好,青藤碱转移率为93.34%。结论:优化后的生产工艺,可以有效提高目标产物青风藤中间体中青藤碱的转移率,同时成品指纹图谱稳定,操作简单,重复性好。This study was aimed to improve the transfer rate of sinomenine in the intermediate product of Caulis Sinomenii in order to optimize the purification process of intermediate product of Caulis Sinomenii from TongAn（TA） injection. The transfer rate of sinomenine and the stability of fingerprints in the intermediate product of Caulis Sinomenii were used as indexes for the investigation on the impact from different pH of Caulis Sinomenii extract before extraction. The transfer rate of sinomenine was used as an index for the investigation on the impact by different pH of hydrochloric acid created to dry extract solution. The transfer rate of sinomenine was used as an index for the investigation of four separation ways, which included the vacuum filtration, plate and frame filters, high-speed tube separator, and flat direct centrifuge, on the liquid separation of sinomenium acutum acid. The results showed that the pH of Caulis Sinomenii extract before extraction was 10-11; the transfer rate of sinomenine was the highest in the extraction process and the fingerprints of TA injection was stable. The pH of hydrochloric acid was 2.0-2.5; and the highest transfer rate of sinomenine in acid dissolution process was 92.94%. The high-speed tube separator had the best separation to sinomenium acutum acid-dissolving liquid. The highest transfer rate of sinomenine was 93.34%. It was concluded that the optimized process can effectively improve the transfer rate of sinomenine in the intermediate product of Caulis Sinomenii. Meanwhile, fingerprints of the product were stable. The process was simple with good repeatability.

关 键 词：痛安注射液 青风藤 转移率 纯化工艺 

分 类 号：R283[医药卫生—中药学]