具有氧化稳定性的间苯三酚薄膜衣片的处方、制备工艺及质量标准研究

发布时间：2018-05-17 23:15

本文选题：间苯三酚 + 薄膜衣片　；参考：《中国新药杂志》2017年17期

【摘要】：目的:制备具有氧化稳定性间苯三酚薄膜衣片,并建立相应的质量控制方法。方法:通过加入抗氧剂和薄膜衣阻隔的双重方法增加间苯三酚口服片剂的稳定性,经正交设计拟订处方组成,筛选出符合要求的处方与制备工艺,采用高效液相色谱法测定间苯三酚含量,并通过影响因素试验考察间苯三酚薄膜衣片的稳定性。结果:按照优化出来的最佳处方及工艺制备的试样品,其质量及溶出度均合格。结论:制剂处方合理,制备工艺简单可行,产品溶出及稳定性良好,质量可控。
[Abstract]:Objective: to prepare mesoglucinol thin film with oxidative stability and establish a quality control method. Methods: the stability of oral mesoglucinol tablets was increased by adding antioxidant and membrane barrier. The prescription composition was formulated by orthogonal design, and the prescription and preparation process were selected. The content of phloroglucinol was determined by high performance liquid chromatography (HPLC), and the stability of phloroglucinol film was investigated by influence factor test. Results: the quality and dissolution of the samples were up to standard. Conclusion: the formulation is reasonable, the preparation process is simple and feasible, the dissolution and stability of the product are good, the quality is controllable.
【作者单位】：中国人民解放军第一六一医院药剂科;国家纳米药物工程技术研究中心;华中科技大学同济医学院附属梨园医院;
【分类号】：R943

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