|本期目录/Table of Contents|

[1]隋洪飞,王姿婧,刘 青,等.星点设计-效应面法优化硝苯地平分散片处方[J].天津医科大学学报,2014,20(04):323-327.
 SUI Hong-fei,WANG Zi-jing,LIU Qing,et al.Optimizing the formation of nifedipine dispersible tablets by central composite design - response surface methodology[J].Journal of Tianjin Medical University,2014,20(04):323-327.
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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
20
期数:
2014年04期
页码:
323-327
栏目:
技术与方法
出版日期:
2014-07-08

文章信息/Info

Title:
Optimizing the formation of nifedipine dispersible tablets by central composite design - response surface methodology
文章编号:
1006-8147(2014)04-0323-05
作者:
隋洪飞12王姿婧3刘 青3杨金荣3房志仲3 朱立勤
(1.天津医科大学研究生院,天津 300070;2.天津医科大学一中心临床学院药学部,天津 300192;3.天津医科大学药学院,天津市临床药物关键技术重点实验室,天津 300070)
Author(s):
SUI Hong-fei12WANG Zi-jing3 LIU Qing3 YANG Jin-rong3 FANG Zhi-zhong3ZHU Li-qin2
(1.Graduate School, Tianjin Medical University, Tianjin 300070,China;2. Department of Pharmacy,The First Center Clinical College,Tianjin Medical University , Tianjin 300192,China;3.College of Pharmacy, Tianjin Medical University,Tianjin Key Laboratory on Technologies Enabling Development of Clinical Therapeutics and Diagnostics (Theranostics),Tianjin 300070,China)
关键词:
硝苯地平分散片星点设计-效应面法处方筛选分散均匀性累积溶出百分率
Keywords:

nifedipine dispersible tablets central composite design-response surface methodology prescription screening dispersible uniformity cumulative dissolution

分类号:
R9
DOI:
-
文献标志码:
A
摘要:
目的:以硝苯地平为模型药物,应用星点设计-效应面法优化其分散片处方。方法:采用固体分散技术,以提高硝苯地平的溶解度。以处方中聚乙二醇4000(PEG4000)、交联聚维酮(PVPP)以及交联羧甲基纤维素钠(CCNa)的含量为考察因素,以分散均匀性和10 min累积溶出百分率为评价指标,根据星点设计原理进行试验,并用多元线性回归和二次多项式方程拟合指标与影响因素之间的数学模型,经效应面法预测最佳处方。结果:采用二次多项式拟合的相关系数优于线性方程,具有较高的可信度。综合效应面优化和评估结果,最佳处方为固体分散体中硝苯地平:PEG4000=1:4,PVPP占处方的15%,CCNa占处方的8%。结论:通过星点设计-效应面优化法所建立的模型可以用于硝苯地平分散片处方的优化。
Abstract:

Objective: To optimize the formulation of dispersible tablets using nifedipine as a model drug by central composite design-response surface methodology. Methods: Solid dispersion method was applied to improve the solubility of nifedipine. The proportion of PEG4000, PVPP and CCNa were studied based on the theory of central composite deign using dispersible uniformity and 10min cumulative dissolution as evaluation indexes. The correlation between evaluation indexes and formulation were simulated using multi-linear equation and second-order polynomial equation. The possible optimal formulation was predicted by response surface method. Results: Second-order fitting models were superior to first-order models with better regression coefficients and higher reliability. The optimized formulation was NFP: PEG4000=1:4 in solid dispersion; the dosage of PVPP and CCNa accounted for 15% and 8% in formulation, respectively. Conclusion: The established model based on the theory of central composite design is suitable for the optimization of nifedipine dispersible tablets.

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备注/Memo

备注/Memo:

作者简介 隋洪飞(1982-),男,主管药师,硕士在读,研究方向:临床药学;通信作者:房志仲,E-mail:fangzhizhong@tijmu.edu.cn。

更新日期/Last Update: 2014-06-06