粉末直接压片法制备甲磺酸多沙唑嗪片

Preparation of Doxazosin Mesylate Tablets by Direct Powder Compression

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.