高速剪切湿法制粒工艺制备氯沙坦钾片

发布时间：2018-04-18 09:47

本文选题：高速剪切湿法制粒 + 氯沙坦钾片　；参考：《沈阳药科大学学报》2017年06期

【摘要】：目的通过优化高速剪切湿法制粒工艺参数制备氯沙坦钾片。方法采用高速剪切湿法制粒工艺制备氯沙坦钾片,通过对制备工艺参数优化:搅拌桨转速(X_1,r·min~(-1))、加水量(X_2,%)和制粒时间(X_3,s)为考察对象,以颗粒粒径大小(D50,Y_1,μm)、片剂硬度(Y_2,N)、15min药物溶出度(Y_3,%)为评价指标,利用Box-Behnken效应面法优化高速剪切湿法制粒工艺参数。结果方差分析结果显示:搅拌桨转速、加水量和制粒时间对颗粒粒径影响较显著(P0.05);加水量、制粒时间对片剂的硬度影响较显著(P0.05);加水量、制粒时间对药物的溶出度影响较显著(P0.05)。结论通过Box-Behnken实验设计法优化高速剪切湿法制粒工艺,可以提高工艺过程的稳健性和灵活性。
[Abstract]:Objective to prepare losartan potassium tablets by optimizing the parameters of high speed wet shearing granulation.Methods Losartan potassium tablets were prepared by high speed wet shearing granulation process. By optimizing the preparation parameters, the speed of the agitator was X 1 / L / min ~ (-1), the quantity of water added was X _ 2 / T _ (2)) and the granulation time was X ~ (3) / s, respectively.The Box-Behnken effect surface method was used to optimize the processing parameters of high speed wet shearing granulation with the particle size of D50 / Y _ (1), 渭 m, and the dissolution rate of Y _ (2) N ~ (-1) in 15 min as the evaluation index, and the method of Box-Behnken effect surface method was used to optimize the process parameters of high speed wet shearing granulation.Results the results of variance analysis showed that the rotation speed of agitator, water addition and granulation time had significant effects on the particle size (P0.05A), water addition and granulation time had significant effects on the hardness of tablets, and water addition and granulation time had a significant effect on the dissolution of the drug.Conclusion the high speed shearing wet granulation process can be optimized by Box-Behnken experimental design method, which can improve the robustness and flexibility of the process.
【作者单位】：杨凌职业技术学院药物与化工学院;
【分类号】：R943

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