【摘要】 目的制备枸橼酸芬太尼口腔黏膜贴片,并评价其质量。方法采用直压工艺制备枸橼酸芬太尼口腔黏膜贴片,以片剂外观性状、崩解时限、酸度、溶出度及离体口腔黏膜稳态渗透速率等指标评价处方的合理性。结果采用直压工艺,以15%无水枸橼酸和21%碳酸氢钠为泡腾剂,以10%无水碳酸钠为p H调节剂,以甘露醇为稀释剂,以羧甲基淀粉钠为崩解剂组成的处方而制备的片剂,制剂质量特性与国外上市品Fentora一致。结论所拟定的枸橼酸芬太尼口腔黏膜贴片处方合理。更多还原

【Abstract】 Objective To prepare and evaluate fentanyl citrate buccal tablets. Methods Direct compression was used to prepare fentanyl citrate buccal tablets. The appearance characteristics, disintegration time, acidity, dissolution and penetration rate were used to evaluate the formulation. Results In the direct compression, 15% anhydrous citric acid and 21% sodium bicarbonate served as the effervescent, 10% anhydrous sodium carbonate as the regulator of acidity, mannitol as the filler, and CMS-Na as the disintegrating agent to preparation fentanyl citrate buccal tablet. The characteristics of the tablets were similar to those of Fentora(USA). Conclusion The formulation is reasonable.更多还原