清开灵口服液生产工艺优化研究*

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L(934)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1 h后提取2次,每次2 h,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。

Optimization in preparation process of Qingkailing oral liquid

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.