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目的:制备索拉非尼干混悬剂,并采用HPLC法对其含量进行测定。方法:采用单因素分析方法,分别考察填充剂、助悬剂、黏合剂和崩解剂对索拉非尼干混悬剂沉降体积比、再分散性及干燥失重的影响,并通过正交试验进行处方工艺的优化。建立HPLC法测定索拉非尼的含量。色谱柱:Inertsil ODS-3柱(250 mm×4.6 mm,5μm);流动相:乙酸铵缓冲液(20mmol·L-1)-乙腈(28∶72);流速:1.0 ml·min-1;检测波长:266 nm;柱温:40℃;进样量:20μl。结果:优化的最佳处方为:蔗糖(用量48%)为填充剂,黄原胶(用量28%)和羧甲基纤维素钠(用量12%)共同作为助悬剂,微晶纤维素(用量10%)作为崩解剂,6%的聚乙烯吡咯烷酮K30(PVP K30)50%乙醇溶液为黏合剂。索拉非尼线性范围为1~100μg·ml-1,r=0.999 8,加样回收率为98.96%(RSD=0.75%,n=9)。结论:筛选优化的处方工艺重复性好,并且建立的HPLC法简便、专属性好,可用于索拉非尼的检测。
Objective: To prepare sorafenib suspension and determine its content by HPLC. Methods: Univariate analysis was used to investigate the influence of filler, suspending agent, binder and disintegrant on the settlement volume ratio, redispersibility and loss on drying of the sorafenib suspension, respectively. The orthogonal test To optimize the prescription process. To establish a HPLC method for the determination of sorafenib. Column: Inertsil ODS-3 column (250 mm × 4.6 mm, 5 μm); mobile phase: ammonium acetate buffer (20 mmol·L-1) Wavelength: 266 nm; column temperature: 40 ° C .; injection volume: 20 μl. Results: The optimum prescriptions were sucrose (48%) as filler, xanthan gum (28%) and sodium carboxymethyl cellulose (12%) as suspending agent and microcrystalline cellulose Dosage 10%) as a disintegrant, 6% polyvinylpyrrolidone K30 (PVP K30) 50% ethanol solution as a binder. Sorafenib linear range of 1 ~ 100μg · ml-1, r = 0.999 8, the sample recovery was 98.96% (RSD = 0.75%, n = 9). Conclusion: The screening and optimization of the prescription process has good reproducibility. The established HPLC method is simple and specific and can be used for the determination of sorafenib.