六味降糖颗粒提取和制剂工艺研究

Study on Extraction and Preparation Process of Liuwei Hypoglycemic Granule

对六味降糖颗粒的提取工艺和制剂工艺进行研究,以干膏重、总黄酮含量为指标,对处方活性成分提取工艺进行影响因素和指标成分分析,采用正交实验考察加水量、煎煮次数、煎煮时间和醇沉浓度等影响因素,采用湿法制粒法研究不同辅料的制剂工艺。最佳制剂工艺是加入10倍量的水,煎煮3次,煎煮1 h,醇沉工艺中乙醇浓度50%,时间12 h,药液比1:2;最佳辅料为β-环糊精。本制剂工艺可行性较强,科学合理,颗粒成药性良好。

Liuwei Hypoglycemic Granule was composed of Pueraria lobata and Salvia miltiorrhiza and other traditional Chinese medicine.The effects of water extraction and alcohol precipitation and granulation process were studied.The influencing factors and the index composition analysis method of the prescription water extraction process were determined.The effects of water addition,boiling time and decocting time on water extraction were investigated by L;(3~4)orthogonal experiment.The optimum water extraction technology was optimized with the weight of the cream and the total flavonoids.The above-mentioned traditional Chinese medicine were boiled with the best water extraction process.The effects of liquid ratio,alcohol concentration and alcohol precipitation time on alcohol precipitation were investigated by L;(3~4)orthogonal experiment.The optimum alcohol precipitation process was optimized with the weight of total paste and total flavonoids.Wet granulation method was used to observe the different excipient of different materials and select optimization of the best excipient of Liuwei Hypoglycemic Granule.The optimum water extraction technology was to cook three times,each time for 1 h,and add 10 times the amount of water.The optimum alcohol precipitation process was as follows ethanol concentration was 50%,alcohol precipitation time was 12 h,liquid ratio was 1:2.The best excipient wasβ-cyclodextrin.Water extraction,alcohol precipitation process and granulation process were stable,scientific and reasonable.