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对桃红四物滴丸所用药材的提取工艺进行筛选、采用新技术及新方法建立制剂制备工艺、采用质量源于设计理念进行相关研究,对所确定工艺参数进行系统的研究及验证,为药物制剂未来报批上市提供了充分的药学基础研究资料。相关研究结果表明所建立制剂工艺路线可行,所确定的生产工艺参数合理可控,所建立的药品质量标准可更有效控制制剂质量。实验研究结果表明,研究确定的桃红四物滴丸的制剂工艺稳定、可行。
The extraction process of the medicinal materials of Taohongsiwu Dropping Pill was screened, the preparation technology was established by new technology and new method, the quality was researched from the design concept, and the determined process parameters were systematically studied and verified. The future approval of the market provides a full basic information on pharmaceutical research. The related research results show that the established process route is feasible and the determined production process parameters are reasonable and controllable. The quality standards of the established drug products can be more effective in controlling the quality of the preparation. Experimental results show that the determination of the Taohong Siwu dropping pills preparation process is stable and feasible.