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目的:确立蛇床子素滴丸的最佳成型工艺,并对其进行溶出度考察。方法:以滴丸的外观、圆整度、丸重变异系数、溶散时限作为评价指标对蛇床子素与基质的配比、滴制的温度、滴距、滴速进行考察,并在单因素试验的基础上采用正交试验对上述因素进行优选。结果:在基质PEG3000∶PEG6000为6∶1,基质与蛇床子素的配比为6∶1,滴制温度为60℃,滴速为12d·min-1,滴距为20cm时,滴丸成型性最好。结论:该工艺简便、可行,评价指标可靠、合理,符合2005年版《中国药典》对滴丸制剂的要求,所得滴丸溶出度良好。
OBJECTIVE: To establish the best forming process of Osthole pill and investigate its dissolution rate. Methods: The ratio of osthole to matrix, dropping temperature, dripping distance and dripping rate were investigated with drop pill appearance, roundness, pill weight coefficient of variation and dissolution time as evaluation indexes. The single factor On the basis of the experiment, the orthogonal experiment was used to optimize the above factors. Results: When the ratio of matrix to osthole was 6:1, the temperature was 60 ℃, the dropping rate was 12d · min-1 and the dropping distance was 20cm, The best sex. Conclusion: The process is simple and feasible. The evaluation index is reliable and reasonable. It conforms to the requirements of the Chinese Pharmacopoeia for the preparation of dropping pills in 2005 edition. The obtained dropping pills have a good dissolution rate.