阿奇霉素掩味干乳的表征及体内外评价

发布时间：2018-02-26 13:46

本文关键词： 阿奇霉素掩味干乳二氧化硅肠黏膜刺激　出处：《药学学报》2017年05期 　论文类型：期刊论文

【摘要】：研制阿奇霉素儿科用掩味口服制剂,采用脂质纳米反胶束技术掩蔽药物的苦味,再以胶态二氧化硅固化含药油溶液制备掩味干乳。通过染色实验证明了干乳处方中油相均匀分散,进一步结合扫描电镜对其进行评价。采用X-射线粉末衍射及扫描电镜测定固体粉末中药物的结晶状态,激光粒度测定仪和透射电镜考察再分散乳滴的粒径大小及其形态特征。通过口腔模拟释放实验和志愿者口尝对制剂掩味效果进行评价,并对制剂进行肠黏膜刺激性评价。结果表明,制备的掩味干乳再分散乳滴平均粒径为530.1 nm,混悬后再分散性良好,混悬液外观均一。与上市制剂希舒美相比,相同剂量下掩味效果相近且肠黏膜刺激性较小,具有很好的发展前景。
[Abstract]:Azithromycin Pediatric Mask Oral preparation was prepared, and the bitter taste of the drug was masked by lipid nanometer reverse micelle technique. Then the dry milk was prepared by curing the medicated oil solution with colloidal silica. The dyeing experiment proved that the oil phase was evenly dispersed in the formulation of dry milk. X-ray powder diffraction and scanning electron microscopy were used to determine the crystalline state of the drug in the solid powder. The particle size and morphological characteristics of redispersed emulsion droplets were investigated by laser particle size analyzer and transmission electron microscope. Oral simulated release test and oral taste of volunteers were used to evaluate the effectiveness of the preparation. The results showed that the average diameter of the prepared dry milk was 530.1 nm, the dispersion of the suspension was good, the appearance of the suspension was uniform. At the same dose, the effect of taste masking is similar and the irritation of intestinal mucosa is small, so it has a good prospect of development.
【作者单位】：天津中医药大学实验教学部;军事医学科学院毒物药物研究所;
【基金】：“十二五”国家重大新药创制资助项目(2015ZX09J15104-003)
【分类号】：R943

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