D-最优混料设计优化3D打印多糖速溶片的处方
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摘要
目的:通过D-最优混料设计优化3D打印多糖速溶片的处方。方法:以山梨醇比例、棉子糖比例、增健多糖比例为考察因素,分别以3D打印最低打印温度、最大打印速度、冷固时间为响应值,通过软件预测最优处方,并对最优处方进行验证。结果:由拟合的各因素回归模型可知3个考察因素和3个考察指标之间存在可信的定量关系;使用最优处方原料进行3D打印结果与预测值非常接近。结论:D-最优混料设计可用于3D打印多糖速溶片处方的优化,所建立的数学模型具有准确的预测性。
Objective: To optimize the formulation of 3 D printing instant polysaccharide tablets by D-optimal mixture design.Methods: The independent variables were the ratio of sorbitol,raffinose and Zengjian polysaccharides,and the lowest printing temperature,the highest printing speed and the shortest cooling time were used as the dependent variables. The results were studied using mixture design by the design-expert to determine the optimal formulation. The validation of the optimal formulation was verified as well.Results: In the optimal regression models,there were reliable quantitative relationships between the three factors and the evaluation indices. The results indicated that there were high approximation between the predicted values and the experimental values. Conclusion:D-optimal mixture experimental design facilitates the formulation optimization of 3 D printing instant polysaccharide tablets. The optimal models are with accurate predictability.
Objective: To optimize the formulation of 3 D printing instant polysaccharide tablets by D-optimal mixture design.Methods: The independent variables were the ratio of sorbitol,raffinose and Zengjian polysaccharides,and the lowest printing temperature,the highest printing speed and the shortest cooling time were used as the dependent variables. The results were studied using mixture design by the design-expert to determine the optimal formulation. The validation of the optimal formulation was verified as well.Results: In the optimal regression models,there were reliable quantitative relationships between the three factors and the evaluation indices. The results indicated that there were high approximation between the predicted values and the experimental values. Conclusion:D-optimal mixture experimental design facilitates the formulation optimization of 3 D printing instant polysaccharide tablets. The optimal models are with accurate predictability.
引文
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16 Goyanes A,Buanz ABM,Basit AW,et al. Fused-filament 3D printing(3DP)for fabrication of tablets[J]. Int J Pharm,2014,476(1-2):88-92
17 Skowyra J,Pietrzak K,Alhnan MA. Fabrication of extended-release patient-tailored prednisolone tablets via fused deposition modelling(FDM)3D printing[J]. Eur J Pharm Sci,2015,68:11-17
18 Melocchi A,Parietti F,Loreti G,et al. 3D printing by fused deposition modeling(FDM)of a swellable/erodible capsular device for oral pulsatile release of drugs[J]. J Drug Deliv Sci Tec,2015,30:360-367
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21 张春燕,赵迎春,范义凤. D-最优混料试验设计法优化阿德福韦酯片处方[J].中国药师,2017,20(12):2160-2164
22 晋兴华,张慧,赵振宇,等. D-最优混料设计优化尼莫地平骨架片的处方[J].中国药学杂志,2009,44(7):516-520
23 盛晓艳.组合药物试验中的试验设计[D].武汉:华中师范大学硕士学位论文,2017
24 金云隆.中药口腔崩解片的研究进展[J].中草药,2018,49(22):5456-5462
25 王巍巍.浅谈中药泡腾片的工艺研究[J].中国林副特产,2014,(4):109-110
26 余琳,李小芳,罗丽佳,等.中药口腔崩解片的国内外研究进展[J].成都中医药大学学报,2015,38(4):109-113
27 肖云芳,王博,林蓉. 3D打印的个性化药物研究进展[J].中国药学杂志,2017,52(2):89-95
2 伏欣.国内增材制造(3D打印)技术发展现状与研究趋势[J].中国高新技术业,2016,(24):27-28
3 言帆. 3D打印技术的发展和应用[J].科技创新与应用,2017,(32):147-148
4 王镓垠,柴磊,刘利彪,等.人体器官3D打印的最新进展[J].机械工程学报2014,50(23):119-127
5 朱敏,黄婷,杜晓宇,等.生物材料的3D打印研究进展[J].上海理工大学报,2017,39(5):473-483
6 王雪,张灿,平其能. 3D打印技术在药物高端制剂中的研究进展[J].中国药科大学学报,2016,47(2):140-147
7 王学成,伍振峰,臧振中,等. 3D打印技术及其在中药固体制剂中的应用展望[J].中国医药工业杂志,2017,48(8):1093-1098
8 范凯燕,杨帆,林启凤,等. 3D打印在中药制剂研究中的应用[J].广东药学院学报,2015,31(5):688-691
9 刘珍,孙明杰.首款3D打印抗癫痫药物—Spritam[J].药学研究,2015,34(9):556-558
10 余灯广,杨祥良,王运赣,等.三维打印技术制备控释药片工艺研究[J].中成药,2007,29(5):679-683
11 何冬林,韩福国,王钊,等.基于熔融沉积成型的3D打印在药物制剂中的研究进展[J].药学学报,2016,51(11):1659-1665
12 柴旭煜,柴鸿宇,杨晶晶,等.熔融沉积成型技术在药物制剂中的应用[J].中国医药工业杂志,2016,47(12):1587-1591
13 Sandler N,Salmela I,Fallarero A,et al. Towards fabrication of 3D printed medical devices to prevent biofilm formation[J]. Int J Pharm,2014,459(1-2):62-64
14 Hollander J,Genina N,Jukarainen H,et al. Three-Dimensional Printed PCL-Based Implantable Prototypes of Medical Devices for Controlled Drug Delivery[J]. J Pharm Sci,2016,105(9):2665-2676
15 Genina N,Hollander J,Jukarainen H,et al. Ethylene vinyl acetate(EVA)as a new drug carrier for 3D printed medical drug delivery devices[J]. Eur J Pharm Sci,2016,90:53-63
16 Goyanes A,Buanz ABM,Basit AW,et al. Fused-filament 3D printing(3DP)for fabrication of tablets[J]. Int J Pharm,2014,476(1-2):88-92
17 Skowyra J,Pietrzak K,Alhnan MA. Fabrication of extended-release patient-tailored prednisolone tablets via fused deposition modelling(FDM)3D printing[J]. Eur J Pharm Sci,2015,68:11-17
18 Melocchi A,Parietti F,Loreti G,et al. 3D printing by fused deposition modeling(FDM)of a swellable/erodible capsular device for oral pulsatile release of drugs[J]. J Drug Deliv Sci Tec,2015,30:360-367
19王延庆,沈竞兴,吴海全. 3D打印材料应用和研究现状[J].航空材料学报,2016,36(4):89-98
20 陈燕洁.药物共晶的设计、合成及性质研究[D].上海:华东师范大学硕士学位论文,2016
21 张春燕,赵迎春,范义凤. D-最优混料试验设计法优化阿德福韦酯片处方[J].中国药师,2017,20(12):2160-2164
22 晋兴华,张慧,赵振宇,等. D-最优混料设计优化尼莫地平骨架片的处方[J].中国药学杂志,2009,44(7):516-520
23 盛晓艳.组合药物试验中的试验设计[D].武汉:华中师范大学硕士学位论文,2017
24 金云隆.中药口腔崩解片的研究进展[J].中草药,2018,49(22):5456-5462
25 王巍巍.浅谈中药泡腾片的工艺研究[J].中国林副特产,2014,(4):109-110
26 余琳,李小芳,罗丽佳,等.中药口腔崩解片的国内外研究进展[J].成都中医药大学学报,2015,38(4):109-113
27 肖云芳,王博,林蓉. 3D打印的个性化药物研究进展[J].中国药学杂志,2017,52(2):89-95