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目的研究影响盐酸青藤碱κ-卡拉胶/魔芋胶骨架片体外释药机制的处方和工艺因素。方法采用粉末直接压片和湿法制粒压片制备盐酸青藤碱κ-卡拉胶/魔芋胶骨架片,考察κ-卡拉胶与魔芋胶配比,骨架材料用量,填充剂种类,片剂大小,压片工艺,压片压力对骨架片体外释药机制的影响。结果盐酸青藤碱κ-卡拉胶/魔芋胶骨架片的释药机制为药物扩散和骨架溶蚀协同作用;随κ-卡拉胶与魔芋胶配比中κ-卡拉胶用量降低,骨架材料用量降低,填充剂水溶性降低,片剂直径增加,压片压力降低,骨架片释药机制中扩散释放所占比重增加;压片工艺对骨架片药物释放机理影响不大。结论κ-卡拉胶与魔芋胶复配可作为载体材料使用延缓盐酸青藤碱κ-卡拉胶/魔芋胶骨架片中药物释放;κ-卡拉胶与魔芋胶配比,骨架材料用量,填充剂种类,片剂直径和压片力为影响骨架片释药机制的主要因素。
Objective To study the prescription and process factors affecting the release mechanism of sinomenine hydrochloride κ-carrageenan/konjac glucomannan matrix tablets in vitro. Methods The sinomenine hydrochloride κ-carrageenan/konjac glucomannan matrix tablets were prepared by powder direct tableting and wet granulation tableting. The ratios of κ-carrageenan to konjac gum, the amount of framework materials, fillers and tablet size were investigated. The Effect of Tableting Technology and Tableting Pressure on the Release Mechanism of Matrix Tablets in . Results The drug release mechanism of sinomenine κ-carrageenan/konjac glucomannan matrix tablet was synergistic between drug diffusion and skeleton erosion. With the decrease of κ-carrageenan dosage in the formulation of κ-carrageenan and konjac gum, the amount of framework material was decreased. The water solubility of fillers decreased, the tablet diameter increased, the tableting pressure decreased, and the proportion of diffusion release in the matrix tablet release mechanism increased. The tableting process had little effect on the matrix release mechanism of drug release. Conclusion The compounding of κ-carrageenan and konjac gum can be used as carrier materials to delay the release of sinomenine hydrochloride κ-carrageenan/konjac glucomannan matrix tablets; the ratio of κ-carrageenan to konjac gum, the amount of framework material, and the type of filler The tablet diameter and tableting force are the main factors affecting the release mechanism of the matrix tablet.