一种兽用地美硝唑预混剂的制备及稳定性研究

Preparation and stability of one kind of Dimetridazole premix for animals

以地美硝唑为主成分原料,以聚乙二醇6000、倍他环糊精作为主成分的助溶剂,地美硝唑和辅料经过过筛、混合后进行粉碎制得地美硝唑预混剂。该配方的组合为:质量比M(地美硝唑):M(倍他环糊精):M(聚乙二醇6000)=2:2:6。研究表明地美硝唑预混剂的溶解度良好,溶解度可达8.0%;按地美硝唑预混剂的质量标准要求检测,合格。该配方组合可以同时实现药物的饮水和拌料给药。在密闭条件下保存,长期试验2年,产品的性状和外观几乎没有改变;地美硝唑含量从初始的100.1%下降至97.5%,有效成分含量下降幅度未超过地美硝唑标示量百分含量的10%。产品质量稳定,符合兽药典的要求。地美硝唑预混剂的配方合理、生产操作简单,产品24个月质量稳定,有效期可暂定为24个月。

The Dimetridazole premix was prepared by mixing and pulverizing the main raw material and auxiliary material of Dimetridazole with Betacyclodextrin and Polyethylene glycol 6000 as co-solvents.The formula combination is M(Dimetridazole):M(Betacyclodextrin):M(Polyethylene Glycol 6000)=2:2:6.The results showed that the solubility of the prepared premix was good,the solubility was up to 8.0%,According to the quality standard of Dimetridazole premix,qualified.The mixed feeding and drinking water administration of insoluble drugs can be realized.After 2 years of long-term storage,the character and appearance of the product were almost unchanged,the content of Dimetridazole decreased from 100.1%to 97.5%,the content of active ingredient did not exceed 10%of the labeled content of Dimetridazole.Product quality is stable,in line with the requirements of veterinary pharmacopoeia.The formulation of Dimetridazole premix is reasonable,the production operation is simple,the quality of the product is stable in 24 months,and the validity period can be tentatively determined as 24 months.