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目的探讨丹皮酚滴丸剂的制备工艺。方法以基质种类、主药与分散基质配比、药液温度为主要因素运用正交L9(34)实验法研究丹皮酚滴丸剂的制备工艺,测定综合分数指标。结果主药与基质配比为1:5,聚乙二醇4000为基质,药液温度为75℃。制备工艺方法较好能达到良好的圆整度、主药逐渐析出、硬度较好。结论丹皮酚滴丸制备工艺条件稳定,可操作性强,产品批间质量分析结果重现性好,该工艺条件可进行工业化生产放大。
Objective To investigate the preparation of paeonol pills. Methods The orthogonal design of L9 (34) was used to study the preparation process of paeonol pills and the comprehensive score index by taking the types of matrix, the ratio of main drug to dispersed matrix and the temperature of liquid as main factors. The results of the main drug and matrix ratio of 1: 5, polyethylene glycol 4000 as the matrix, liquid temperature 75 ℃. The preparation method is better to achieve a good roundness, the main drug gradually precipitated, the hardness is better. Conclusion The preparation conditions of paeonol dropping pills are stable, the maneuverability is good, and the quality analysis results between lots are reproducible. The process conditions can be expanded for industrial production.