丹皮酚-羟丙基-β-环糊精包合物的制备及处方工艺优化
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篇名: 丹皮酚-羟丙基-β-环糊精包合物的制备及处方工艺优化
TITLE:
摘要: 目的:制备丹皮酚-羟丙基-β-环糊精(PAE-HP-β-CD)包合物,优化其处方工艺。方法:采用冷冻干燥法制备PAE- HP-β-CD包合物并进行验证。以包合率为指标,主药-辅料投料比、包合时间、包合温度与搅拌速度为因素,采用星点设计-响应面法优化其处方工艺。结果:制备的PAE-HP-β-CD包合物发生了物相转变。最优处方工艺为主药-辅料投料比3.39 ∶ 1、包合温度50 ℃、包合时间3.2 h、搅拌速度350 r/min;所制得包合物的包合率测得值(87.46%)与预测值(89.12%)的相对误差为1.86%(n=6)。结论:成功制得PAE-HP-β-CD包合物,且其处方工艺稳定可行。
ABSTRACT: OBJECTIVE: To prepare paeonol-HP-β-cyclodextrin (PAE-HP-β-CD) inclusion compound and to optimize its prescription technology. METHODS: PAE-HP-β-CD was prepared by freeze drying method and validated. Using inclusion rate as index, main drug-accessory ratio, inclusion time, inclusion temperature and stirring speed as factors, the preparation technology was optimized by central composite design-response surface methodology. RESULTS: Prepared PAE-HP-β-CD underwent phase transformation. The optimal inclusion technology was as follows as main drug-accessory ratio of 3.39 ∶ 1, inclusion temperature of 50 ℃, inclusion time of 3.2 h, stirring speed of 350 r/min. Relative error between measured value (87.46%) and predicted value (89.12%) of inclusion rate was 1.86% (n=6). CONCLUSIONS: PAE-HP-β-CD inclusion compound is prepared successfully, and its prescription technology is stable and feasible.
期刊: 2017年第28卷第4期
作者: 郑欣,杨培洪,何霖,陈希,程模,游必波
AUTHORS: ZHENG Xin,YANG Peihong,HE Lin,CHEN Xi,CHENG Mo,YOU Bibo
关键字: 丹皮酚;羟丙基-β-环糊精;包合物;星点设计-响应面法;制备工艺;优化
KEYWORDS: Paeonol; HP-β-CD; Inclusion compound; Central composite design-response surface methodology; Prescription technology; Optimization
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