知百安神口服液制备工艺优化及稳定性研究  

Stability study and manufacture process optimization for Zhibai Anshen oral liquid

作　　者：虞慧华 李静娴 江春霞 庞涛 陈万生 朴淑娟 YU Huihua;LI Jingxian;JIANG Chunxia;PANG Tao;CHEN Wansheng;PIAO Shujuan(Naval Medical University,Depatment of Pharmacy,Changhai Hospital,Shanghai 200433,China;Naval Medical University,Depatment of Pharmacy,Changzheng Hospital,Shanghai 200003,China)

机构地区：[1]海军军医大学长海医院药学部,上海200433 [2]海军军医大学长征医院药学部,上海200003

出　　处：《药学实践杂志》2021年第6期549-551,576,共4页Journal of Pharmaceutical Practice

基　　金：国家自然科学基金项目(81773991);上海市科学技术委员会科研计划项目(17401901300)。

摘　　要：目的优化知百安神口服液制备工艺,并对其稳定性进行考察。方法以芒果苷的含量为指标,对提取工艺中加水量、提取时间、醇沉浓度3个因素进行考察,采用正交试验法优选工艺,并对成品制剂进行为期6个月加速试验和12个月长期稳定性考察。结果确定最佳工艺条件为:加10倍量水煎煮1 h,醇沉浓度为60%。结论该方法可为知百安神口服液工业化生产提供一定的科学依据。Objective To optimize the manufacture process for Zhibai Anshen oral liquid.Methods The orthogonal designed experiments were conducted to monitor the effects of three factors on the content of mangiferin.The three factors included the amount of water,extraction time and alcohol precipitation concentration.Six month accelerated stability study and twelve month long term stability study were performed.Results Optimum percolation process was boiling the mixture with 10 times of water for 1 hour,followed by deposition with 60%alcohol.Conclusion This optimized process can be used for mass production.

关 键 词：知百安神口服液 芒果苷 制备工艺 

分 类 号：R943[医药卫生—药剂学] R927.2[医药卫生—药学]