替米考星三元固体分散体的制备、鉴定及体外累积溶出量研究  

Study on preparation, identification and in vitro cumulative dissolution of tilmicosin ternary solid dispersion

作　　者：伍涛[1] 邓余[1] WU Tao;DENG Yu(Chongqing Academy of Animal Sciences,Chongqing 402460,China)

机构地区：[1]重庆市畜牧科学院,重庆402460

出　　处：《黑龙江畜牧兽医》2021年第11期118-121,共4页Heilongjiang Animal Science And veterinary Medicine

基　　金：重庆市技术创新与应用发展专项面上项目“肠溶缓释型替米考星固体分散体的创制与应用”(cstc2019jscx-msxmX0344)。

摘　　要：为改善替米考星(TMC)的适口性和胃刺激性,试验以丙烯酸树脂(Eudragit L100)和聚乙烯己内酰胺-聚乙酸乙烯酯-聚乙二醇接枝共聚物(Soluplus)为联合载体,采用喷雾干燥法制备替米考星三元固体分散体,用傅里叶变换红外光谱法进行物相鉴定,并考察替米考星三元固体分散体的体外累积溶出量。结果表明:制备的替米考星三元固体分散体为晶体结构,替米考星以无定形态分散于载体中。替米考星三元固体分散体120分钟时在酸中的溶出量为7.23%,45分钟时在缓冲液中的累积溶出量为96.06%,符合2015年版《中华人民共和国兽药典》一部中对肠溶制剂的溶出量规定。说明研究制备的替米考星三元固体分散体工艺简单可行,可解决替米考星口服制剂的适口性和胃刺激性问题。In order to improve the palatability and gastric irritation of tilmicosin, Eudragit L100 and Soluplus were used as the combined carrier to prepare tilmicosin ternary solid dispersion by spray drying method, and the phase identification was carried out by Fourier transform infrared spectroscopy;in vitro cumulative dissolution of tilmicosin ternary solid dispersion was investigated. The results showed that the prepared ternicosin ternary solid dispersion had a crystalline structure, and tilmicosin was dispersed in the carrier in an amorphous form. Tilmicosin ternary solid dispersion had a dissolution rate of 7.23% in acid at the 120 th minute, and a cumulative dissolution rate of 96.06% in buffer at the 45 th minute, which complied with the regulations for the dissolution of enteric-coated preparation in the first part of the 2015 edition of Chinese Veterinary Pharmacopoeia. The results suggested that the ternicosine ternary solid dispersion prepared in this study was simple and feasible, and effectively solved the palatability and gastric irritation problems of tilmicosin oral preparation.

关 键 词：替米考星 三元固体分散体 制备 鉴定 累积溶出量 

分 类 号：S859.53[农业科学—临床兽医学] S859.796[农业科学—兽医学]