摘要
目的优化扶正益胃口服液的生产工艺。方法利用高效液相色谱(HPLC)法对处方中白芍所含的芍药苷进行含量测定;再以芍药苷含量和粘度为指标,利用星点设计-效应面法对煎煮时间、料液比、含醇量等条件进行筛选,优选最佳提取工艺。结果确定了最佳提取工艺为加入9倍量的水煎煮95min,含醇量需调节至65%。结论星点设计-效应面法适用于该制剂的工艺优化,建立的数学模型具有良好的预测性。
Objective To optimize the preparation of Fuzheng Yiwei Oral solution.Methods High performance liquid chromatography(HPLC)was applied in determining the content of paeoniflorin and then taking the content and viscosity of paeoniflorin as the criteria,central composite design-response surface method was applied in screening the conditions of decoction time,volume fraction and alcohol content for optimal preparation.Results The optimal extraction was gained by boiling the medicinal materials with 9 times more pure water for 95 minutes and adjusting the alcohol content to 65%.Conclusions Central composite design-response surface method is applicable to optimizing the preparation of Fuzheng Yiwei Oral sulution and the set-up digital modal is of good predictability.
引文
[1]李捷玮,金柔男,李翔,等.多种中成药中芍药苷的含量测定[J].药物分析杂志,2009,29(9):1440-1443.
[2]张明,倪颖,金伟华,等.星点设计-效应面法优化扶正生血胶囊纯化工艺[J].成都中医药大学学报,2013,36(3):35-39.
[3]翟永松,尚雅文,龚慕辛,等.星点设计-效应面法优选糖肾宁颗粒乙醇提取工艺的研究[J].中成药,2015,37(1):99-104.
[4]陈家润,江映珠,吴雪龙.广东省医疗机构制剂质量标准修订存在问题及对策[J].中国药事,2016,30(3):209-214.
[5]伍振峰,郑琴,杨明,等.中药制剂质量控制的方法模式分析与研究[J].中国中药杂志,2012,37(9):1332-1336.
[6]吴伟,崔光华.星点设计-效应面优化法及其在药学中的应用[J].国外医学药学分册,2000,27(5):292-298.
[7]林福林,杨昌云,杨薇薇,等.中药白芨的现代研究概况[J].中国医院药学杂志,2013,33(7):571-573.