侯飞 罗四海 方夏琴 张宇佳 郑稳生

    [摘要] 目的 优选阿司匹林肠溶片制备工艺，并对其体外质量一致性进行评价。 方法 以体外溶出度为指标，采用正交实验考察L100-55、柠檬酸三乙酯和滑石粉3个因素，筛选最佳包衣处方用量。以乙腈-四氢呋喃-冰醋酸-水(20∶5∶5∶70)为流动相，C18色谱柱，检测波长276 nm;流速1.0 mL/min为色谱条件，并用直接比较法和f2因子判断自制片与参比制剂体外溶出行为的相似性。 结果 正交试验结果表明，各因素水平最佳组合为A2B3C1D3。3批自制片中阿司匹林含量分别为标示量的98.9%、100.3%、99.9%，均符合《中华人民共和国药典》规定。在pH 1.2盐酸溶液中自制片基本没有释放，在pH 6.0、pH 6.2、pH 6.8的溶介中自制片与参比制剂的f2值分别为50%、65%、80%。 结论 该制剂处方配比简单，工艺可行度好、重复性高，可用于指导工业化生产。本研究所建立的分析方法，可用于阿司匹林肠溶片的质量控制。

    [关键词] 阿司匹林肠溶片;制备工艺;正交实验;参比制剂;溶出度

    [中图分类号] R943? ? ? ? ? [文献标识码] A? ? ? ? ? [文章编号] 1673-7210(2019)01(c)-0101-04

    [Abstract] Objective To optimize the preparation process of Aspirin enteric-coated tablets and evaluate its quality consistency in vitro. Methods Three factors including L100-55， TEC and talc powder were investigated by orthogonal experiment with in vitro dissolution as the index to screen the optimal prescription dosage. Using acetonitrile-tetrahydrofuran-glacial acetic acid-water (20∶5∶5∶70) as mobile phase， C18 column with detection wavelength of 276 nm and flow rate of 1.0 mL/min as chromatographic conditions， the similarity of dissolution behavior of self-made tablets and reference preparations in vitro was determined by direct comparison method and f2 similarity factor. Results Orthogonal test showed that the best combination of factors was A2B3C1D3. The contents of aspirin in three batches of self-made tablets were 98.9% ......