摘要
目的：改进冠心宁注射液的二次醇沉及后续工艺。方法：以滤渣质量为指标,考察二次醇沉后冷藏、过滤步骤的必要性。以丹参素钠、原儿茶醛、迷迭香酸、阿魏酸、丹酚酸B含量为指标,考察加入乙醇的体积分数、药液含醇量及pH对二次醇沉及后续工艺的影响。结果：原标准工艺中＂冷藏＂可忽略不计。二次醇沉时用90%乙醇调节含醇量至80%,用40%NaOH调pH 8.0~8.2。结论：改进后工艺可有效提高冠心宁注射液中5种特征药效成分的含量,更好地控制药液颜色及成品质量,缩短了生产周期,可推广应用。
Objective： To improve secondary ethanol precipitation and subsequent processes of Guanxinning injections.Method： With residue mass as index,necessity of frozen and filtration steps after secondary ethanol precipitation was investigated.With the contents of sodium danshensu,protocatechuic aldehyde,rosmarinic acid,ferulic acid and salvianolic acid B as indexes,effects of the concentration of adding ethanol,pH and ethanol concentration on secondary ethanol precipitation and subsequent processes were investigated.Result： Frozen step in original standard process could be negligible.The contents of five kinds of characteristics components in Guanxinning injections were all improved effectively when ethanol content was adjusted to 80% with 90% ethanol in secondary alcohol precipitation and pH was adjusted to 8.0-8.2 after secondary alcohol precipitation.Conclusion： Improvement process of Guanxinning injections could better control liquid color and finished products quality,it could be widely applied with shortening production cycle.
出处
《中国实验方剂学杂志》
CAS
北大核心
2013年第18期33-35,共3页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家发改委产业振兴和技术改造项目(20121938)
关键词
冠心宁注射液
醇沉工艺
工艺改进
丹参素钠
原儿茶醛
迷迭香酸
阿魏酸
丹酚酸B
Guanxinning injections
precipitation process
process improvement
sodium danshensu
protocatechuic aldehyde
rosmarinic acid
ferulic acid
salvianolic acid B
作者简介
高治华，主管药师，从事新药开发研究，Tel：0352-6116692，E-mail：327827906@qq．com
[通讯作者]刘近荣，高级经济师，从事新药研究与开发，Tel：0352-6116692，E-mail：sxtsljr@163．com
