痛安注射液配液过程中除杂工艺优化研究  

Impurity removal technology of Tongan injection in liquid preparation process

作　　者：杨绪芳[1,2] 王秀海[2] 柏伟荣[1,2] 康小东[1,2] 刘俊超[1,2] 吴云[1,2] 萧伟[1,2] 

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

出　　处：《中国中药杂志》2015年第16期3200-3203,共4页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2013ZX09402203)

摘　　要：为了有效去除痛安注射液中无效杂质,优化配液过程中除杂工艺的最佳参数,该文以痛安注射液为研究对象,以白屈菜碱的质量浓度、青藤碱的质量浓度、固含物减少率、有关物质检查结果等为评价指标,考察冷藏、热处理、碳吸附等工艺对药液中杂质及有关物质的去除情况,优化工艺参数并确定除杂方法的可行性。结果表明,冷藏时间36 h,热处理时间15 min,活性炭用量0.3%,100℃吸附10 min,能够有效的去除痛安注射液中鞣质等杂质,保证成品的质量和安全性。In order to effectively remove the invalid impurities in Tongan injection, optimize the optimal parameters of the impurity removal technology of liquid mixing process, in this paper, taking Tongan injection as the research object, with the contents of celan- dine alkali, and sinomenine, solids reduction efficiency, and related substances inspection as the evaluation indexes, the removal of impurities and related substances by the combined process of refrigeration, coction and activated carbon adsorption were investigated, the feasibility of the impurity removal method was definited and the process parameters were optimized. The optimized process parame- ters were as follows： refrigerated for 36 h, boiled for 15 min, activated carbon dosage of 0. 3% , temperature 100 ℃, adsorption time 10 min. It can effectively remove the tannin, and other impurities, thus ensure the quality and safety of products.

关 键 词：痛安注射液 配液 除杂工艺 鞣质 

分 类 号：R283.6[医药卫生—中药学]