石榴皮泡腾颗粒剂的研制

目的]研究石榴皮泡腾颗粒剂的制备工艺。方法]采用超声法提取石榴皮,以乙醇浓度、提取次数、料液比和提取温度为因素,以总黄酮的含量为指标,采用L9(34)正交试验优选最佳提取工艺参数;将提取物精制,浓缩,加辅料混合制成泡腾颗粒,并检测泡腾颗粒的休止角、水分、溶化性和粒度。结果]超声提取法的最佳工艺条件为:乙醇浓度70%、提取1次、料液比1∶25(g/ml)、提取时间30 min;颗粒剂处方为:石榴皮稠膏10 g、乳糖74 g、蔗糖46 g、柠檬酸33 g、碳酸氢钠25 g、聚乙二醇6000 14 g、浓度70%乙醇适量;制得的颗粒休止角为29.6o,流动性好,颗粒剂水分、粒度和溶化性均符合药典规定。结论]石榴皮泡腾颗粒的制备工艺简便,质量稳定、可控,适合于工业化生产。

Study on the Preparation Process of PERICARPIUM GRANATI Effervescent Granules

Objective] To explore the preparation process of PERICARPIUM GRANATI effervescent granules.Method] Taking the content of total flavonoids as an index,the ultrasonic extraction process of PERICARPIUM GRANATI was optimized by means of L9(34) orthogonal test with ethanol concentration,extraction times,solid-liquid ratio,extraction temperature as experimental factors.Refined extract and adjuvants were mixed to prepare effervescent granules.The angle of repose,moisture content,dissolubility,and particle size of effervescent particles were detected.Result] The optimum ultrasonic extracting conditions of PERICARPIUM GRANATI were as follows: solvent of 70% ethanol,extraction times of 1,extraction time of 30 min and solid-liquid ratio of 1∶ 25 g/ml.The formula of effervescent granules was established as follows: PERICARPIUM GRANATI thick paste 10 g,lactose 74 g,cane sugar 4 g,citric acid 3 g,sodium bicarbonate 25 g,polyethylene glycol 6000 14 g,70% ethanol.The angle of repose of effervescent granules was 29.6o and showed good liquidity.The moisture content,the particle size and the dissolubility of granules conformed to the pharmacopoeia stipulation.Conclusion] The preparation process is simple,and the quality is stable and controllable,so it is fit for industrialized production of PERICARPIUM GRANATI effervescent granules.