蛇床子素滴丸制备工艺及溶出度研究

Study on Preparation of Osthole Dropping Pills and Its Dissolution

摘要:

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12 d ·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。

Abstract:

Objective: To establish the optimum preparation process and investigate its dissolution of Osthole droping pills. Method: The proportion of osthole to matrix, processing temperature, drops distance and drops speed on the basis of the preliminary experiments were investigated with the spherical degree, the weight coefficient of variation, dissolved casual time and appearance evaluation of the dropping pills as the scoring indexes, and ultraviolet measuring technology was used to study its dissolution. Result: The optimal conditions were that proportion of matrix to osthole was 6 ∶1, matrix PEG3000:PEG6000 was 6 ∶1, processing temperature was at 60 ℃, drops rate at 12 d ·min^-1 and 20cm distance above liquid level. Conclusion: The preparation method is simple, convenient and can be controlled easily. It is also consistent with the items on pills preparation requirements in Ch.P (2005). The dissolution of products is good.