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目的:确立山楂叶总黄酮滴丸的最佳成型工艺。方法:采用正交试验法,以滴丸的外观质量、溶散时间以及滴丸的重量差异系数为评价指标,优选药物与基质的配比、混合基质配比、药液的温度以及冷却剂温度,确定最佳滴制条件。结果:最佳条件为山楂叶总黄酮与基质比为1:5,混合基质配比PEG 4000:PEG 6000=1:2,药液温度为85℃,冷却剂温度为10℃。结论:本方法确定的山楂总黄酮滴丸制备工艺稳定可行。
Objective: To establish the best forming process of hawthorn leaf flavonoids dropping pills. Methods: The orthogonal test was used to evaluate the quality of dropping pills, the dissolution time and the weight difference coefficient of dropping pills. The ratio of drug to matrix, the ratio of mixed matrix, the temperature of liquid and the temperature of coolant , Determine the best dropping conditions. Results: The optimal conditions were as follows: the ratio of total flavonoids to matrix in hawthorn leaves was 1: 5, PEG 4000: PEG 6000 = 1: 2, the liquid temperature was 85 ℃ and the temperature of the coolant was 10 ℃. Conclusion: The hawthorn flavonoids dropping pills determined by this method are stable and feasible.