熊去氧胆酸软胶囊的制备工艺研究

Study on the Prepared Technology of Ursodeoxycholic Acid Soft Capsules

摘要: 目的研究熊去氧胆酸软胶囊的制备工艺。方法通过不同处方与工艺对比研究,确定本制剂处方及制备方法,并进行中试试验。结果以大豆油为基质,蜂蜡为助悬剂,80 ℃混匀,室温下压丸,处方组成及制备工艺合理,制剂稳定。结论工艺可行,适合工业化生产。

Abstract: OBJECTIVE To study the preparation technology of ursodeoxycholic acid soft capsules. METHODS With using different formulation and process,the ursodeoxycholic acid soft capsules were prepared，then the best were selected in the pilot preparation.RESULTS By mixing ursodeoxycholic acid and soybean oil and beeswax at 80 ℃ and preparing at room temperature.The formulations and process was reasonable.The finished product was stable. CONCLUSION This prepared technology is compatible with industrialisation.