理气复胃口服液的制备工艺研究

目的研究理气复胃口服液的制备工艺。方法对制备工艺中含挥发性成分药材的蒸馏条件,以及其他药材的煎煮工艺,醇沉条件,增溶剂的选择和溶液pH值进行考察,以确定该口服液的最佳制备工艺。结果对含挥发性成分药材的蒸馏采用二次蒸馏法;其他药材煎煮过程为三次,第一次用水10倍,煎煮1小时,第二次用水5倍,煎煮0.5h,第三次用水5倍,煎煮0.5h,共2h;醇沉浓度为75%;以0.6%聚山梨酯-80为增溶剂;药液pH值为5.0～7.0的工艺条件,即可制得产品质量稳定的理气复胃口服液剂。结论该制备工艺合理可行,所制得理气复胃口服液符合药典对口服液的质量要求。

Study on preparation technology of Liqi Fuiwei oral solution

Objective To study the preparation process for Liqi Feiwei oral solution. Methods The preparation process of Liqi Feiwei oral solution was optimized through investigating the distillation condition for medicinal material contained volatile constituents,decoction process for other medicinal material,alcohol-precipitation procedure,the selections of solubilizer and solution pH values. Results The best preparation process was as follows： the distillation for medicinal material contained volatile constituents was carried out twice; the decoction for other medicinal material was carried out thrice,with 10 times volume of water for 1.0 h decoction and with 5 times volume of water for 0.5 h decoction ,at last,with 5 times volume of water for 0.5 h decoction, about 1.5 hours time total. The the best alcohol-precipitation procedure was determined as 75% alcohol. Using Polysorbate 80 as solubilizer ,and Solution pH value was 5.0-7.0. Conclusion The preparing process is rational and available,and stable and controllable in quality.