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目的:研究影响山红调脂滴丸制备工艺的各种因素,确立最佳制备工艺。方法:采用正交设计试验方法,以溶散时限、圆整度为指标确定滴丸的处方工艺,以丸重合格率为指标筛选滴丸滴制条件。结果:最佳工艺为滴制温度为85℃,PEG4000与PEG6000比例为1∶1,药物与基质的比例为1∶5,冷却温度10℃,滴距10cm,滴速20～30滴/min。结论:制得的滴丸溶散时限、圆整度及丸重均符合质量要求,该工艺合理、简便。
Objective: To study the various factors that affect the preparation process of Shanhong Tiaozhi dripping pills and establish the best preparation process. Methods: Orthogonal design test method was used to determine the prescription of dripping pills by taking dissolving time limit and roundness as index, and selecting the dropping pills dripping condition with the passing rate of pills and pills as index. Results: The optimum conditions were as follows: temperature 85 ℃, ratio of PEG4000 to PEG6000 1: 1, ratio of drug to matrix 1: 5, cooling temperature 10 ℃, dripping distance 10cm, dropping speed 20-30 drops / min. Conclusion: The prepared drip pill dissolves time limit, roundness and pill weight are in line with the quality requirements, the process is reasonable and easy.