摘要
目的:优选甲磺酸多沙唑嗪片粉末直接压片法最佳制备工艺。方法:采用粉末直接压片法,以粉末休止角、片子脆碎度及溶出度为评价指标,制备样品并进行质量考察。结果:所选处方粉末流动性良好,有效成分溶出速率高,各项指标均符合规定。经6个月加速及室温留样考察,样品的外观、含量、有关物质及溶出度均未发生明显变化。结论:优选的处方工艺操作简便、经济、生产周期短,制备的产品质量稳定,适合产业化生产。
Objective:To optimize the preparation process of Doxazosin Mesylate tablets by direct powder compression.Methods: Tile samples were prepared by direct powder compression and the quality was inspected, with powder angle of repose, tablet friability and drug dissolution as evaluation indexes.Results: The selected folaalulation had promising powder fluidity and dissolution rate. The quality of the tablets was accorded with the relative requirements. After 6 months of accelerated test and storage at room temperature, the appearance, content, related substance and dissolution of the samples had no significant change. Conclusions: The selected formulation and process was characteristic of convenient operation, economy, short production cycle, stable product quality, and was suitable for industrialized production.
出处
《北方药学》
2012年第11期22-23,共2页
Journal of North Pharmacy
关键词
甲磺酸多沙唑嗪
粉末直接压片
稳定性
制备工艺
Doxazosin Mesylate Direct Powder Compression Tablets Stability Preparation Process