目的 优选理气复胃口服液的醇沉除杂质工艺,为提升制剂质量及规模化生产提供参考.方法 以理气复胃口服液水提取药液醇沉后大黄结合蒽醌转移率、醇沉后干膏收率为测定指标,采用正交实验法,考察水提浓缩药液相对密度、乙醇浓度、醇沉时间对醇沉工艺的影响.结果 以大黄结合蒽醌转移率为指标,各考察因素对测定值的影响程度为:乙醇浓度>醇沉时间>相对密度;以干膏率为指标时,各考察因素对其影响程度为:相对密度>乙醇浓度>醇沉时间.结论 依据试验结果,平衡各种影响因素并结合生产实际,优选出的醇沉除杂工艺为:药液相对密度为1.20～1.25,乙醇浓度为75％,醇沉时间为24小时.该工艺可改善理气服胃口服液的澄明度,也为其规模化生产提供了数据支撑.%Objective To optimize the ethanol sedimentation process of Liqifuwei oral liquid in order to provide the reference for improving the quality and large-scale production of the oral liquid .Methods By using the anthraquinone transfer ratio of ethanol sedimentation solution and the yield of dry extract as indexes ,the effect of the relative density of concentrated liquor extracted by water , the ethanol concentration and the alcohol precipitation time on the ethanol precipitation process was investigated with orthogonal experi -ment method .Results When anthraquinone transfer rate as detecting index ,the various influence on the ethanol precipitation process were that ethanol concentration >alcohol precipitation time >the relative density .When the yield of dry extract as detecting index ,the various influence on the ethanol precipitation process were that relative density >ethanol concentration >alcohol precipitation time . Conclusion According to the test results,balancing various influences factors and combining with the actual production ,the optimal alcohol sedimentation process is that the relative density of concentrated liquor extracted by water is 1.20～1.25 ,ethanol concentration was 75％and alcohol precipitation time was 24 hours.The optimized process could improve the clarity of Liqifuwei oral liquid ,and pro-vide data supporting its large-scale production as well .
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