Objective To research a new preparation process of the taste masked particles of clarithromycin and evaluate the quality.Methods The clarithromycin pellets were prepared by coating the main medicine layer and a resin layer on blank pellets using the fluid-bed coating technology,and then the pellets were mixed with other materials and granulated to provide the taste masked particles of clarithromycin.Results The taste masked particles of clarithromycin tasted good without bitterness using this method of preparation.The accumulated release of the taste masked particles of clarithromycin in the phosphate buffer (pH=7) in 45 minutes was over 85％ and the average yield was more than 88.3％.Conclusion The taste masked particles of clarithromycin conformed to the quality standard in the Chinese Pharmacopoeia 2015 edition and the United States Pharmacopoeia after 10 days stored under high temperature (60 ℃),light (4500Lx) and high humidity (RH=95％).%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pH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.
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