丹参口服液制备工艺优化及稳定性研究  

Stability and preparation technology for optimizing Danshen oral liquid

作　　者：黄雨婷[1,2] 沈夕坤[3] 蒋斌[3] 迟宗良 秦昆明 石芸 

机构地区：[1]南京中医药大学国家教育部中药炮制规范化及标准化工程研究中心,南京210023 [2]南京海昌中药集团有限公司江苏省企业研究生工作站,南京210061 [3]南京中医药大学附属苏州中医医院,江苏苏州215003 [4]南京易亨制药有限公司,南京210018

出　　处：《中南药学》2017年第6期776-779,共4页Central South Pharmacy

基　　金：江苏省自然科学基金项目(No.BK20141094);江苏省中医药局科技项目(No.PY201518);江苏省战略性新兴产业引导资金项目

摘　　要：目的优化丹参口服液制备工艺,并对其稳定性考察。方法以原儿茶醛的含量为指标,对提取工艺中加水倍量、醇沉浓度、醇沉后静置温度3个因素进行单因素考察,采用正交试验法优选工艺,并对其进行6个月稳定性考察。结果确定最佳工艺条件为加8倍量水,碱水煎煮3次,明胶-乙醇除鞣质,醇沉浓度为60%,冷藏(4℃)放置。结论该方法合理可行、质量可控,为丹参口服液工业化生产提供科学依据的指导。Objective To optimize the preparation technology for Danshen oral liquid. Methods The single fac- tor experiment combined with orthogonal design was used to detect 3 factors, including the amount of water, al- cohol precipitation concentration and laying temperature by taking the main active ingredients of protocatechui- caldehyde, and studied the preliminary stability for 6 months. Results Optimum oercolation nrocess was adding 8 times of water, and extracting 3 times with alkaline. Tannis was deposited by gelatin and 60% ethanol, and stored at 4 ℃. Conclusion This optimized preparation technology is reasonable and feasible, which provides the basis for mass production.

关 键 词：丹参口服液 原儿茶醛 制备工艺 

分 类 号：R284[医药卫生—中药学]