胡椒酸乙酯固体分散体的制备及体外溶出度研究
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篇名: 胡椒酸乙酯固体分散体的制备及体外溶出度研究
TITLE:
摘要: 目的:研究胡椒酸乙酯固体分散体的制备及体外溶出度。方法:采用溶剂熔融法。选择聚乙二醇6000(PEG-6000)为载体,考察不同药载质量比(1 ∶ 1、1 ∶ 5、1 ∶ 7、1 ∶ 10、1 ∶ 15、1 ∶ 18、1 ∶ 20)对胡椒酸乙酯固体分散体溶出度的影响;考察胡椒酸乙酯原料药在85 ℃时的稳定性;采用差示扫描量热法、X射线粉末衍射表征胡椒酸乙酯在固体分散体中的存在状态。结果:胡椒酸乙酯与PEG-6000药载质量比为 1 ∶ 15时胡椒酸乙酯的溶出度显著提高,且在85 ℃制备条件下稳定;胡椒酸乙酯PEG-6000固体分散体中药物以无定形或分子形式存在。结论:胡椒酸乙酯与PEG-6000(1 ∶ 15)混合制备固体分散体可显著提高药物溶出度,且在85 ℃条件下稳定。本研究为胡椒酸乙酯制剂制备工艺研究提供了依据。
ABSTRACT: OBJECTIVE: To study the preparation and in vitro dissolution of ethyl pepper solid dispersion. METHODS: Solvent-melting method was adopted. Using polyethylene glycol 6000 (PEG-6000) as carrier, the effects of different drug-loading ratios (1 ∶ 1, 1 ∶ 5, 1 ∶ 7, 1 ∶ 10, 1 ∶ 15, 1 ∶ 18, 1 ∶ 20) on the dissolution of ethyl pepper solid dispersion was invesigated. The stability of crude drug ethyl pepper at 85 ℃ was determined. Furthermore, differential scanning calorimetry and X-ray powder diffraction method were used to identify the existence of ethyl pepper in the solid dispersion. RESULTS: The dissolution of ethyl pepper could be improved by mixing ethyl pepper and PEG-6000 in a ratio of 1 ∶ 15, and the preparation was maintained stable at 85 ℃. The drugs part of ethyl pepper-PEG-6000 solid dispersions existed in the form of amorphous or molecular. CONCLUSIONS: The dissolution of ethyl pepper solid dispersion can be improved significantly by mixing ethyl pepper and PEG-6000 (1 ∶ 15), and the dispersion keeps stable at 85 ℃. The study can provide reference for further study of the preparation technology of ethyl pepper preparation.
期刊: 2016年第27卷第22期
作者: 王艳丽,王艳杰,博·格日勒图
AUTHORS: WANG Yanli,WANG Yanjie,Bo·Geriletu
关键字: 胡椒酸乙酯;固体分散体;聚乙二醇6000;溶出度
KEYWORDS: Ethyl pepper; Solid dispersion; PEG-6000; Dissolution
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