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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 of doxazosin mesylate tablets by direct compression method. Methods: Powder direct compression method, the angle of repose of the powder, the friability of the film and the dissolution rate were taken as the evaluation indexes to prepare the samples and conduct the quality inspection. Results: The selected prescription powder has good fluidity, high dissolution rate of active ingredients and all the indexes are in accordance with the regulations. After 6 months of accelerated and room temperature sample inspection, the sample appearance, content, related substances and dissolution did not change significantly. Conclusion: The preferred prescription process is simple, economical, short cycle, the quality of the prepared products is stable, suitable for industrial production.