抗球虫药新剂型的制备与研究

Preparation and research of a new dosage form of anticoccidial drug

采用固体分散技术,利用溶剂法,以处方比例马度米星铵:聚维酮(聚乙烯吡咯烷酮,PVPk30)分别为1:1、1:2、1:3制备了3个马度米星铵固体分散体,通过差示扫描量热法(DSC)分析鉴定,当马度米星铵与PVP k30的比例为1:3时马度米星铵的药物特征吸热峰消失,说明固体分散体制备成功。对药物进行体外累积溶出度研究,结果马度米星铵固体分散体在60 min内体外累积溶出度可达98.46%,比马度米星铵预混剂的2.57%提高了38倍多。抗球虫效果研究表明,马度米星铵固体分散体的抗球虫指数(ACI)为197.7,明显高于ACI为191.8的马度米星铵预混剂。

Solid dispersion technique was explored to prepare maduramicin ammonium solid dispersions by solvent method, which maduramicin ammonium and providone （PVP k30）was in proportion of 1 ： 1,1 ： 2, 1 ： 3 respectively. Differential scanning calorimetry （DSC） was used to examine the physical and chemical characteristics of solid dispersions. The results showed that the characteristic peak of madu- ramicin ammonium disappeared when the proportion of maduramicin ammonium and PVP k30 was 1 ： 3,suggesting that maduramicin ammonium solid dispersion had been prepared. Dissolution rate of madu- ramicin ammonium solid dispersion was 98.46%, more than 38 times comparing with that of maduramicin ammonium premix. Anti-coccidia index （ACI） of the maduramicin ammonium solid dispersion was 197.7.