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本研究考察了不同工艺因素对双氯芬酸钾(DFP)颗粒及胶囊的物理特性、体外溶出度、短期和长期稳定性的影响.采用湿法制粒方法,制备DFP颗粒,制粒溶剂中水/乙醇比例越低,所生成总有关物质越少.与50℃或60℃干燥相比,湿物料在70℃干燥时,有关物质生成更多.DFP颗粒制备过程中,药物对强光比较稳定.水/乙醇溶剂比例为1∶4时,DFP颗粒的粒度较小,休止角较大.4种不同水/乙醇溶剂比例制备的DFP颗粒,其10分钟溶出度均低于2％,而30分钟溶出度可达95％. DFP胶囊(水/乙醇,1∶4)的有关物质显著低于DFP胶囊(水/乙醇,1∶0).在高温(60℃)或强光(4500±500 Lux)下保存10天,DFP胶囊稳定性差,但在高湿条件(92.5％ RH)比较稳定.在长期稳定性试验条件(25±2℃,60％± 10％相对湿度)下保存12个月,DFP颗粒的稳定性优于DFP胶囊.2个月长期稳定性数据表明,胶囊材料种类对DFP的稳定性无影响.总之,DFP颗粒对溶剂种类和干燥温度敏感,而DFP胶囊须在低温、避光条件下保管.“,”This study aimed to investigate the effects of different process parameters on the physical properties,in vitro dissolution rate,and short and long-term stability of diclofenac potassium (DFP) granules and capsules.DFP granules exhibited low total amounts of impurities when prepared through the wet granulation method using a granulating solvent with a low water/ethanol ratio.The impurities of the wet DFP mass dried at 70 ℃ were higher than those dried at 50 ℃ or 60 ℃.DFP granules were stable under strong light exposure during preparation.DFP granules prepared using a granulating solvent with a 1∶4 water/ethanol ratio had a relatively smaller particle size and higher angle of repose than those prepared using granulating solvents with other water/ethanol ratios.The dissolution rate of DFP capsules prepared using four different water/ethanol ratios was less than 2％ after 10 min of dissolution and increased to 95％ within 30 min of dissolution.The total amount of drug impurities of DFP capsules prepared using a granulating solvent with 1∶4 water/ethanol ratio was considerably lower than those of DFP capsules prepared using a granulating solvent with a 1∶0 water/ethanol solvent ratio.Regardless of the water/ethanol ratio,the capsules showed poor stability when exposed to high temperature (60 ℃) and strong light (4500±500 Lux) for 10 days,but were relatively stable at high humidity (92.5％ RH).The results of the long-term stability (25±2 ℃ and 60％±10％ relative humidity) study showed that DFP granules were more stable than DFP capsules,and were stable for 12 months.The type of encapsulating material did not affect the 2-month stability of DFP.DFP granules are sensitive to granulating solvent and drying temperature and DFP capsules should be stored away from high temperature and strong light.