999感冒灵醇沉工艺得失均衡研究

醇沉工艺是现代中药生产中常用的精制方法,其目的是去除杂质而提高药品疗效。但是,由于包裹损失等原因,醇沉过程难免会造成有效成分部分损失。所以,判定醇沉工艺优劣的重要依据在于相关物质的得失均衡。作为感冒药,感冒灵在临床上得到了广泛和良好的使用,其生产工艺的各环节需要有针对性的深入研究。该文着眼于感冒灵水提液醇沉工艺过程的去除杂质和保留有效成分的平衡关系,选择了有效成分蒙花苷的保留率和干浸膏得率作为评价指标,前者反映有效成分保留,而后者反映杂质去除。研究工作用单因素实验,考察了醇沉时间、初始乙醇浓度、终点乙醇含量及初膏密度等多种工艺因素对感冒灵醇沉的影响,在得失均衡的原则下确定了感冒灵醇沉工艺的优化参数是,醇沉时间为16 h,初始乙醇浓度为95%,终点乙醇含量为70%,初膏相对密度为1.10。该研究的意义在于,它为感冒灵醇沉工艺优化提供实验研究基础,同时对于其他中药口服剂的醇沉工艺优化也有借鉴作用。

Study on balance of process of alcohol precipitation of ganmaoling granules

Ganmaoling granule is the first brand of domestic cold medicine sales, but its preparation method and process control parameters are relatively rough. Therefore it is urgent to upgrade the technologies of large varieties of traditional Chinese medicine (TCM). This paper focused on the balance between the remove of impurity and the retention of linarin during the process of alcohol precipitation of Ganmaoling granules. The effects of four factors on the process were investigated via single factor experiments. The results showed that the precipitating period, the initial ethanol concentration and the final ethanol concentration had a great effect on retention of linarin while the initial density of the extract has not. Similarly, the initial ethanol concentration, the final ethanol concentration and the initial extract density have a great effect on the yield of dry extract while the time of alcohol precipitation has not. The parameters of alcohol precipitation of Ganmaoling granules were optimized as 16 h of precipitating period, 95% ethanol as the initial reagent, 70% of the final ethanol concentration, and 1.10 of the initial extract density.