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清开灵口服液生产工艺优化研究*
王磊1, 高辉2, 谌爱富2, 刘二伟1, 王家龙1
1.天津中医药大学中医药研究院, 天津市中药化学与分析重点实验室 300193;2.唐山容大药业有限公司 063020
摘要:
[目的]优化清开灵口服液提取醇沉工艺条件。[方法]高效液相色谱(HPLC)法监测指标成分栀子苷,采用L9(34)正交实验法,考察水提取和醇沉工艺。[结果]清开灵口服液优化工艺条件为:取处方量栀子、板蓝根和金银花,用9倍量水浸泡药材1h后提取2次,每次2h,合并2次提取液浓缩至生药量与浓缩液体积比1:1,加入95%乙醇调节乙醇浓度为70%,调pH值为6进行醇沉;栀子苷的转移率为64.8%。[结论]该优选工艺重现性好,栀子苷转移率高,固形物收率适宜,达到了生产工艺优化的目的。
关键词:  清开灵口服液  栀子苷  HPLC  正交实验  提取纯化
DOI:10.11656/j.issn.1673-9043.2012.02.13
分类号:
基金项目:* 科技部国际合作项目(2008DFB30070);天津市高教科技发展基金项目(0090209)
Optimization in preparation process of Qingkailing oral liquid
WANG Lei1, GAO Hui2, CHAN Ai-fu2, LIU Er-wei1, WANG Jia-long1
1.TCM Chemistry and Analysis Key Laboratory of Tianjin, Tianjin 300193, China;2.Pharmaceutical Co. Ltd of Tangshan Rongda, Tangshan 063020, China
Abstract:
[Objective] To optimize the condition for the extraction and alcohol-purification process of Qingkailing oral liquid.[Methods] Monitoring geniposide by HPLC detection means,the orthogonal design L9 (34) was used for the inspection of water-extracting process and alcohol-precipitating process.[Results] The condition for the extraction and purification process of Qingkailing oral liquid was as follows: soaking the medicinal materials with 9 folds of water for 1 hour, decocting 2 times for 2 hours. Both alcohol precipitated solutions were concentrated to the concentration of 1:1(material:solution volume), then added 95% alcohol,precipitated by 70% alcohol solution, moderated pH to 6; the extraction rate of geniposide was 64.8%.[Conclusion] The optimum process is repeatable, the extraction rate of geniposide is high, recovery rate of solids are suitable. This research result has attained the goal of optimizing production process.
Key words:  Qingkailing oral liquid  geniposide  HPLC  orthogonal test  extraction and purification
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