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一种兽用地美硝唑预混剂的制备及稳定性研究

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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.
Preparation and stability of one kind of Dimetridazole premix for animals
The Dimetridazole premix was prepared by mixing and pulverizing the main raw material and auxiliary material of Dimetri-dazole with Betacyclodextrin and Polyethylene glycol 6000 as co-solvents.The formula combination is M(Dimetridazole):M(Betacy-clodextrin):M(Polyethylene Glycol 6000)= 2:2:6.The results showed that the solubility of the prepared premix was good,the solubili-ty was up to 8.0%,According to the quality standard of Dimetridazole premix,qualified.The mixed feeding and drinking water admin-istration of insoluble drugs can be realized.After 2 years of long-term storage,the character and appearance of the product were al-most 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 for-mulation 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.

DimetridazoleBetacyclodextrinPolyethylene glycol 6000 CosolventStabilityExpiration date

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厦门惠盈动物药业有限公司 福建厦门 361023

地美硝唑 倍他环糊精 聚乙二醇6000助溶剂 稳定性 有效期

2024

福建畜牧兽医
福建省农科院畜牧兽医研究所 福建省畜牧兽医学会 福建农林大学动物科学学院

福建畜牧兽医

影响因子:0.278
ISSN:1003-4331
年,卷(期):2024.46(1)
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