星点设计-响应面法优化布地奈德缓释片处方
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篇名: 星点设计-响应面法优化布地奈德缓释片处方
TITLE:
摘要: 目的:优化布地奈德缓释片处方。方法:以2、4、8 h的累积释放度为考察指标,采用星点设计-响应面法优化布地奈德缓释片处方中羟丙基纤维素L(HPC-L)用量、大豆磷脂用量、填充剂(固定总量200 mg)乳糖-微晶纤维素质量比,并进行验证。比较所制缓释片与原研制剂在pH 7.2、7.0、6.8的磷酸盐缓冲液中的释药行为。结果:最优处方为布地奈德9 mg、HPC-L 46.49 mg、大豆磷脂 9.23 mg、填充剂乳糖-微晶纤维素质量比为1 ∶ 2.9;所制缓释片在2、4、8 h的累积释放度分别为21.9%、50.1%、99.5%,与预测值(22.0%、50.0%、98.5%)的相对误差分别为0.45%、0.20%、1.02%(n=3),与原研制剂的累积释放度比较相似因子f2均大于50。结论:成功制得布地奈德缓释片,其释药行为与原研制剂相似。
ABSTRACT: OBJECTIVE: To optimize the formulation of Budesonide sustained-release tablet. METHODS: Using the cumulative releases in 2, 4, 8 h as investigation indexes, central composite design-response surface method was used to optimize the amount of hydroxypropylcellulose L (HPC-L), amount of soybean phosphatides, and filler (fixed total 200 mg) lactose - microcrystalline cellulose mass ratio in the formulation of Budesonide sustained-release tablet, and the verification test was conducted. The release behaviors of prepared sustained-release tablet and original preparation in pH 7.2, 7.0, 6.8 phosphate buffer were compared. RESULTS: The optimal formulation was as follow as budesonide of 9 mg, HPC-L of 46.49 mg, soybean phosphatides of 9.23 mg, filler lactose-microcrystalline cellulose mass ratio of 1 ∶ 2.9; the cumulative releases in 2, 4, 8 h were 21.9%, 50.1%, 99.5%, the relative errors with predicted values (22.0%, 50.0%, 98.5%) were 0.45%, 0.20%, 1.02% (n=3), respectively. Compared with cumulative release of original preparation, the f2 was higher than 50. CONCLUSIONS: Budesonide sustained-release tablet is successfully prepared, which shows similar release behavior to original preparations.
期刊: 2017年第28卷第10期
作者: 任远志,张涛,黄华,刘秀洁,周劲松
AUTHORS: REN Yuanzhi,ZHANG Tao,HUANG Hua,LIU Xiujie,ZHOU Jingsong
关键字: 布地奈德;缓释片;星点设计-响应面法;处方筛选
KEYWORDS: Budesonide; Sustained-release tablet; Central composite design-response surface method; Formulation screening
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