|本期目录/Table of Contents|

[1]邢正英,李继彬,李 晗,等.星点设计-效应面法优化枸橼酸西地那非分散片处方[J].天津医科大学学报,2017,23(01):74-78.
　XING Zheng-ying,LI Ji-bin,LI Han,et al.Optimizing the formation of sildenafil citrate dispersible tablets by central composite design-response surface methodology[J].Journal of Tianjin Medical University,2017,23(01):74-78.
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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
23卷
期数:
2017年01期
页码:
74-78
栏目:
技术与方法
出版日期:
2017-01-16

文章信息/Info

Title:
Optimizing the formation of sildenafil citrate dispersible tablets by central composite design-response surface methodology
文章编号:
1006-8147（2017）01-0074-05
作者:

邢正英; 李继彬; 李 晗; 杨金荣; 房志仲

?

(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):
XING Zheng-ying;  LI Ji-bin;  LI Han;  YANG Jin-rong;  FANG Zhi-zhong
(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:

line-height: 125%; " align="left">枸橼酸西地那非分散片; 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:
sildenafil citrate 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：以枸橼酸西地那非为模型药物，采用星点设计-效应面法优化分散片的处方。方法： 在筛选优化分散片处方时采用星点设计-效应面优化法结合单因素考察的方法。在预试验的基础上，以处方中內加交联羧甲基纤维素钠(CCNa)、外加交联羧甲基纤维素钠(CCNa)以及羟丙甲基纤维素(HPMC)的含量为考察因素，以分散均匀性和15 min累积溶出百分率为评价指标，根据星点设计的原理进行试验，并采用多元线性回归和多元非线性回归拟合两个评价指标与影响因素之间的数学模型，经效应面法预测得到最佳处方。鉴于本分散片在15 min的累积溶出百分率大于85%，可不与原研制剂进行f(2)因子的比较。结果：数据表明，多元非线性拟合的相关系数高于线性拟合，具有较高的可信度。综合效应面优化和评估结果，最佳处方确定为内加CCNa为30 mg，外加CCNa为40 mg，HPMC为0 mg。结论：通过星点设计-效应面优化法所建立的模型可以用于枸橼酸西地那非分散片处方的优化。

Abstract:
Objective: To optimize the formulation of dispersible tablets using silde-nafil citrate as a model drug by central composite design-response surface methodolo-gy. Methods: In this study, the central composite design- response surface methodology with single factor method was applied to screen and optimize prescription .On the basis of preliminary experiments, the proportion of CCNa(inside and outside the particles) and HPMC were set up as study factors, and dispersible uniformity and 15 min cumulative dissolution were set up as evaluation indexes. According to the theory of central composite design, the correlation between evaluation indexes and formulation was simulated using multi-linear equation and multi-nonlinear equation. The possible optimal formulation was predicted by response surface method. Due to the fact that the 15 min cumulative dissolution of the dispersible tablets was higher than 85%, there was no need to compare the f(2) factors with original development agents. Results: The data shown that multi-nonlinear equation models were superior to multi-linear equation models with better regression coefficients and higher reliability. It was determined that the dosage of CCNa (inside and out-side the particles) and HPMC were 30 mg, 40 mg and 0 mg in the optimized formulation, respectively. Conclusion: The established model based on the central composite design-response surface methodology may be suitable for the optimization of sildenafil citrate dispersible tablets.

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备注/Memo

备注/Memo:
作者简介 邢正英（1994-），女，硕士在读，研究方向：药物制剂与质量控制；通信作者：房志仲，E-mail：fangzhizhong@tijmu.edu.cn。
更新日期/Last Update: 2017-01-16