一种新的工艺制备克拉霉素掩味颗粒

发布时间：2018-04-21 21:02

  本文选题：克拉霉素 + 微丸　； 参考：《中国抗生素杂志》2017年10期

【摘要】：目的研究一种新的工艺制备克拉霉素掩味颗粒并评价制剂质量。方法利用流化床包衣技术,在空白丸芯上依次喷涂主药层和树脂层,制成克拉霉素微丸,所得微丸与其他辅料混合,制粒得到克拉霉素掩味颗粒。结果该方法制备的克拉霉素掩味颗粒口感良好无苦味,在p H为7.0的磷酸盐缓冲液中45min累积释放率大于85%,平均收率大于88.3%。结论通过影响因素试验初步评价了其稳定性,在强光、高温和高湿度条件下放置10d,性状、含量及有关物质符合2015版《中华人民共和国药典》和《美国药典》有关克拉霉素掩味颗粒质量要求。
[Abstract]:Objective to study a new process for preparing clarithromycin flavor granules and evaluate the quality of the preparation. Methods Clarithromycin pellets were prepared by using fluidized bed coating technique. Clarithromycin pellets were prepared by spraying the main and resin layers on the blank pellets in turn. The pellets were mixed with other excipients to produce clarithromycin mask granules. Results the clarithromycin granules prepared by this method had a good taste without bitter taste. The cumulative release rate of 45min in phosphate buffer solution with pH = 7.0 was more than 85 and the average yield was more than 88.3. Conclusion the stability was evaluated preliminarily by the influence factor test, and the stability was evaluated under the condition of strong light, high temperature and high humidity for 10 days. The content of Clarithromycin and its related substances were in accordance with the quality requirements of the 2015 edition of the Pharmacopoeia of the people's Republic of China and the American Pharmacopoeia of Clarithromycin.
【作者单位】： 湖北工业大学生物工程与食品学院;武昌工学院食品工程学院;
【分类号】：R943
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本文编号：1784080