辅料对顿咳颗粒喷雾干燥工艺的影响及优选
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摘要
目的:研究辅料对顿咳颗粒喷雾干燥工艺的影响,筛选出适宜辅料并对其配比进行优化。方法:采用单因素实验法,选择糊精、β-环糊精、可溶性淀粉、微粉硅胶、微晶纤维素、乳糖、麦芽糊精7种辅料,每种辅料加入顿咳组方提取液比例为5%、10%、15%、20%,以得粉率为指标,综合分析粘壁性、软化点之间的关系,筛选出可显著提高制剂得粉率的辅料;并通过混料设计实验,以得粉率为指标,得到3种辅料与制剂提取液固形物含量的最优配比。结果:辅料对粘壁性改善的效果依次为微粉硅胶≥麦芽糊精>糊精>β-环糊精>微晶纤维素>可溶性淀粉>乳糖;混料设计回归方程为Y=89.97019A+56.63562B+22.35114C+77.77848D-595.47310BD,P=0.0490,优化结果为制剂浓缩液中固形物含量∶糊精∶微粉硅胶∶麦芽糊精=0.85∶0.05∶0.05∶0.05。结论:微粉硅胶、麦芽糊精和糊精3种辅料对顿咳颗粒得粉率的提高效果显著,是解决顿咳颗粒生产过程防粘壁的理想辅料。
Objective: To study the influence of excipients on the spray drying process of cough granules, and to select suitable excipients and optimize the proportion of them. Methods: Seven kinds of excipients including dextrin, β-cyclodextrin,soluble starch, micro-powder silica gel, microcrystalline cellulose, lactose and maltodextrin were selected by single factor experiment. The proportion of extracts added to each excipient was 5%, 10%, 15% and 20% in the cough group. The relationship between stickiness and softening point was comprehensively analyzed, and the excipients which could significantly improve the powder yield of the preparation were screened out. The optimum ratio of three excipients to solid content in the extract of the preparation was obtained by mixing design experiment with the powder yield as the index. Results: The effect of excipients on the improvement of adhesion was as follows: micro-silica> malt dextrin> dextrin >β-cyclodextrin> microcrystalline cellulose>soluble starch> lactose; blending design regression equation(Y=89.97019 A+56.63562 B+22.35114 C+77.77848 D-595.47310 BD,P=0.0490). The optimization results were as follows: solid content in the preparation concentrate∶Dextrin∶Micro-powder Silica gel∶Malt dextrin =0.85∶0.05∶0.05∶0.05. Conclusion: Micro-powder silica gel, malt dextrin and dextrin three kinds of excipients have a remarkable effect on improving the powder rate of cough granules, which is the ideal accessory for preventing the sticking wall in the production process of the cough granules.
Objective: To study the influence of excipients on the spray drying process of cough granules, and to select suitable excipients and optimize the proportion of them. Methods: Seven kinds of excipients including dextrin, β-cyclodextrin,soluble starch, micro-powder silica gel, microcrystalline cellulose, lactose and maltodextrin were selected by single factor experiment. The proportion of extracts added to each excipient was 5%, 10%, 15% and 20% in the cough group. The relationship between stickiness and softening point was comprehensively analyzed, and the excipients which could significantly improve the powder yield of the preparation were screened out. The optimum ratio of three excipients to solid content in the extract of the preparation was obtained by mixing design experiment with the powder yield as the index. Results: The effect of excipients on the improvement of adhesion was as follows: micro-silica> malt dextrin> dextrin >β-cyclodextrin> microcrystalline cellulose>soluble starch> lactose; blending design regression equation(Y=89.97019 A+56.63562 B+22.35114 C+77.77848 D-595.47310 BD,P=0.0490). The optimization results were as follows: solid content in the preparation concentrate∶Dextrin∶Micro-powder Silica gel∶Malt dextrin =0.85∶0.05∶0.05∶0.05. Conclusion: Micro-powder silica gel, malt dextrin and dextrin three kinds of excipients have a remarkable effect on improving the powder rate of cough granules, which is the ideal accessory for preventing the sticking wall in the production process of the cough granules.
引文
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[5]蒋艳荣,张振海,刘丹,等.正交试验优选馨月舒胶囊气相二氧化硅辅助喷雾干燥工艺.中华中医药杂志,2013,28(8):2393-2396
[6]张丽华,关志宇,陈丽华,等.D-最优混料设计优选新疆一枝蒿滴丸处方.中国医院药学杂志,2014,34(11):877-880
[7]关志宇,吴文婷,刘亚丽,等.D-最优混料设计优选五味金色分散片制剂处方.中国医院药学杂志,2016,36(2):90-93
[2]郑秀棉,杨莉,王峥涛.车前子的化学成分与药理活性研究进展.中药材,2013,36(7):1190-1193
[3]孙爱静,庞素秋,王国权.中药白及化学成分与药理活性研究进展.环球中医药,2016,9(4):507-508
[4]周学永,高建保.喷雾干燥粘壁的原因与解决途径.应用化工,2007,36(6):599-602
[5]蒋艳荣,张振海,刘丹,等.正交试验优选馨月舒胶囊气相二氧化硅辅助喷雾干燥工艺.中华中医药杂志,2013,28(8):2393-2396
[6]张丽华,关志宇,陈丽华,等.D-最优混料设计优选新疆一枝蒿滴丸处方.中国医院药学杂志,2014,34(11):877-880
[7]关志宇,吴文婷,刘亚丽,等.D-最优混料设计优选五味金色分散片制剂处方.中国医院药学杂志,2016,36(2):90-93