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正交试验法优选染料木素固体分散体制备工艺
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| 篇名： | 正交试验法优选染料木素固体分散体制备工艺 |
| TITLE： | |
| 摘要： | 目的：优选染料木素固体分散体的制备工艺。方法：以45 min的累计溶出度和溶出50％所用的时间（t1/2）的综合评分为指标，通过单因素试验和正交试验考察药载比（m/m）、熔融温度、搅拌时间、表面活性剂及过筛目数对染料木素固体分散体制备工艺的影响，并进行验证试验。采用高效液相色谱法测定染料木素含量，色谱条件为Diamonsil C18色谱柱，流动相为甲醇-0.05％磷酸（70 ∶ 30），检测波长为262 nm，柱温为30 ℃，进样量为10 μl。结果：固体分散体的最优制备工艺为药载比1 ∶ 9，熔融温度75 ℃，搅拌时间10 min，过40目筛，不加表面活性剂。按最优制备工艺所制的3批样品的t1/2分别为23.32、23.10、23.28 min，累计溶出度分别为91.90％、89.63％、90.08％。结论：优化的制备工艺可行，成功制得染料木素固体分散体。 |
| ABSTRACT： | OBJECTIVE： To optimize preparation process of Genistein solid dispersions. METHODS： With the cumulative dissolution for 45 min and the time of 50％ dissolution （t1/2） as index， single factor test and orthogonal test were used to investigate the effects of drugs and carrier ratio （m/m）， melting temperature， mixing time， surfactants and mesh sieve on preparation process， and validated.The content of genistein was determined by HPLC. Chromatographic conditions were as follows as Diamonsil C18 column， mobile phase consisted of methanol-0.05％ phosphoric acid （70 ∶ 30）， detection wavelength 262 nm， column temperature 30 ℃， sample size 10 μl. RESULTS： Optimal preparation process was as follows as drugs and carrier ratio of 1 ∶ 9， melting temperature 75 ℃， mixing time 10 min， mesh sieve 40， no active agent. t1/2 of 3 batches of samples prepared by optimized preparation technology were 23.32， 23.10 and 23.28 min， and cumulative dissolution of them were 91.90％， 89.63％ and 90.08％， respectively. CONCLUSIONS： Optimized preparation process is reliable， and Genistein solid dispersion is prepared successfully. |
| 期刊： | 2016年第27卷第4期 |
| 作者： | 包琳琳，孟庆杰，潘五九，王伟明 |
| AUTHORS： | BAO Linlin，MENG Qingjie，PAN Wujiu，WANG Weiming |
| 关键字： | 染料木素；固体分散体；正交试验；制备工艺 |
| KEYWORDS： | Genistein； Solid dispersion； Orthogonal test； Preparation process |
| 阅读数： | 286 次 |
| 本月下载数： | 6 次 |
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