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[摘要]
目的 对比Parteck? M200、M100直压甘露醇和直压甘露醇C、D 4种不同型号甘露醇对吲达帕胺直接压片的影响,为直接压片选择辅料提供参考。方法 以吲达帕胺为模型药物考察粉体学,采用直压工艺与4种甘露醇压片后,进行片剂质量分析比较。结果 4种型号甘露醇对模型药物均有很好的容纳性,Parteck? M200、M100直压甘露醇与吲达帕胺的相容性及混合压片后的溶出度较好。结论 甘露醇是良好的直压工艺的填充剂,不同型号的甘露醇与模型药物混合有一定的差异。
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[Abstract]
Objective To compare the effects of four different types of mannitol, such as Parteck? M200, M100, and mannitol C and D on indapamide for direct compression tableting and to provide the reference for the selection of production excipients for direct compression tableting. Methods The powder properties of four kinds of mannitol were compared. Using four kinds of mannitol to trial-produce Indapamide Tablets, the differences of the four kinds of mannitol were compared through analysis on the quality of tablets. Results All the four types of mannitol had a good containment on model drugs; Parteck? M200 and M100 had a better compatibility of indapamide and a higher dissolution of its tablets. Conclusion Mannitol is a good filler for direct pressure process, and different types of mannitol have the certain influence on the content uniformity of model drugs.
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