阿奇霉素干混悬剂适口性比较与改善

Comparison and improvement of palatability for multisourced oral azithromycin suspension

阿奇霉素干混悬剂是儿科临床最常用的药物之一,但其不良口感掩蔽一直难以实现。选取5款具有代表性的已上市的阿奇霉素干混悬剂产品,联合采用人尝法和电子舌这2种体内外口感评价方法,确定现有产品间存在苦味、回苦味、砂砾感、黏附性等口感差异;采用显微拉曼成像技术,确定上述口感差异来源于不同处方辅料和制备工艺;将各家产品与碱性混合溶媒临时调配,在确保药液均匀性前提下,确定各家产品的不良口感均被掩蔽,且统一调整为溶媒本身的适口味道,实现了该制剂的掩味目的。后期拟开展溶媒临配后制剂稳定性和生物利用度考察,在保证药效的前提下给出临床掩味建议。

Azithromycin dry suspension is one of the most commonly used drugs in pediatric clinic,but its taste masking has been difficult to achieve.5 representative products of azithromycin dry suspension were chose to compare their tastes both using electronic tongue and human sensory evaluation methods,and there existed the differences of bitterness,later bitterness,graininess,and adhesion among these products.Raman micro-imaging was used to determine the difference in taste mainly due to different prescription ingredients and manufacturing techniques.Through mixing the dry suspensions with alkaline mixing solvent,the bad taste of each product was masked after evenly dispersing in the solvent,and their tastes were all close to the taste of the solvent.In the future,it is planned to investigate the stability and bioavailability of the solvent preparations,and then to give the medication suggestion of solvent preparation after ensuring their efficacy.