|本期目录/Table of Contents|

[1]吕 玥,李继彬,邢正英,等.复方阿托伐他汀钙与依折麦布胶囊剂的处方优化研究[J].天津医科大学学报,2017,23(05):469-474.
　Lü Yue,LI Ji-bin,XING Zheng-ying,et al.Study on prescription optimization of the Compound atorvastatin calcium and ezetimibe capsule[J].Journal of Tianjin Medical University,2017,23(05):469-474.
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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05期
页码:
469-474
栏目:
技术与方法
出版日期:
2017-09-20

文章信息/Info

Title:
Study on prescription optimization of the Compound atorvastatin calcium and ezetimibe capsule
文章编号:
1006-8147(2017)05-0469-06
作者:
吕 玥1; 2; 李继彬3; 邢正英3; 房志仲3

 

（1.天津医科大学研究生院，天津 300070；2.天津市南开医院药剂科，天津 300100；3.天津医科大学药学院药剂学教研室，天津市临床药物关键技术重点实验室，天津 300070）
Author(s):
Lü Yue1; 2; LI Ji-bin3; XING Zheng-ying3; FANG Zhi-zhong3
(1.Gradute School, Tianjin Medical University, Tianjin 300070，China；2.Department of Pharmacy, Tianjin Nankai hospital, Tianjin 300100，China;3. Department of Pharmacy, 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:
阿托伐他汀钙;  依折麦布;  复方胶囊;  星点设计-效应面优化
Keywords:
atorvastatin calcium;  ezetimibe;  compound capsules;  central composite design- response surface methodology
分类号:
R94
DOI:
-
文献标志码:
A
摘要:
目的：星点设计-效应面优化法设计复方阿托伐他汀钙依折麦布胶囊的最佳处方及工艺。方法：对复方制剂采取分开制粒的方式，首先利用单因素考察方法大致确定处方中部分辅料的种类与用量，然后分别采用正交设计和星点设计，主要以药物在PBS 4.5和水两种介质中的溶出度为评价指标，进行筛选优化，以期得到最佳的处方与工艺。结果：经处方筛选确定最终处方为：依折麦布部分：依折麦布10 mg；十二烷基硫酸钠(SDS) 10 mg；聚维酮(PVP) 40 mg；微晶纤维素(MCC) 70 mg；羧甲基淀粉钠(CMS-Na)50 mg。阿托他汀钙部分：阿托伐他汀钙10 mg；NaHCO3 10 mg；羟丙基纤维素(HPC) 50 mg；MCC 28.2 mg；一水乳糖80 mg。硬脂酸镁外加1.8 mg。结论：按照最终确定的复方阿托伐他汀钙依折麦布胶囊的处方与工艺所制得制剂性状良好，含量均匀，与对照制剂相比，溶出行为相似。
Abstract:
Objective: To optimize the prescription and technology of atorvastatin calcium and ezetimibe of capsule compound by central composite design and response surface. Methods: The two medicines were granulated individually. Single factor method was applied to determine types and approximate amounts of some materials used in the prescription at first, then orthogonal experimental design and central composite design-response surface methodology were used to screen and optimize the prescription and the preparation process by the evaluation criteria of dissolutions in medium of sodium acetate 4.5 and aqueous. Results: The ultimate prescription was determined as follows. The part of Ezetimibe consisted of ezetimibe 10 mg; SDS 10 mg; PVP 40 mg; MCC 70 mg；CMS-Na 50 mg. The part of atorvastatin calcium is composed by atorvastatin calcium 10 mg; NaHCO3 10 mg; HPC 50 mg; MCC 28.2 mg and lactose monohydrate 80 mg. Besides, 1.8 mg magnesium stearate was mixed out of above two parts. Conclusion: Preparations with the optimized prescription of the compound capsules of ezetimibe and atorvastatin calcium show good traits and uniform content. Compared with the control formulation, its dissolution behavior is similar.

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备注/Memo

备注/Memo:
作者简介 吕玥（1988-），女，药师，硕士在读，研究方向：临床药学；通信作者：房志仲，E-mail:fangzhizhong@tmu.edu.cn。
更新日期/Last Update: 2017-09-21