一种兽用阿苯达唑伊维菌素粉的制备及稳定性研究

Preparation and stability of albendazole ivermectin powder for animals

以阿苯达唑、伊维菌素为主原料,十二烷基硫酸钠为润湿剂,倍他环糊精、聚乙二醇6000为助溶剂,主原料与辅料经过混合、研磨粉碎制得阿苯达唑伊维菌素粉。配方组合为质量比M(阿苯达唑):M(伊维菌素):M(十二烷基硫酸钠):M(倍他环糊精):聚乙二醇6000=10:0.2:8:20:61.8。考察制得的阿苯达唑伊维菌素粉水中分散性良好,符合干混悬剂的沉降体积比要求,按阿苯达唑伊维菌素粉的质量标准检测为合格,低含量的伊维菌素含量均匀度符合要求,可以实现难溶性药物阿苯达唑的拌料和饮水给药。密闭保存,长期试验24个月,性状、外观几乎无改变;干燥失重由2.4%升高至2.6%;阿苯达唑含量由99.2%下降至97.3%;伊维菌素含量由100.2%下降至97.0%,含量下降不超过药物标示量百分含量的10%,符合规定。该阿苯达唑伊维菌素粉配方组成合理,工艺简单科学、操作简便,产品质量合格且稳定,有效期暂定为2年。

Albendazole ivermectin powder was prepared by mixing,grinding and pulverizing albendazole ivermectin powder with albendazole and ivermectin as main raw materials,sodium dodecyl sulfate as wetting agent,beta cyclodextrin and polyethylene glycol 6000 as cosolvent.The formula combination is M(albendazole):M(ivermectin):M(sodium dodecyl sulfate):M(beta cyclodextrin):polyethylene glycol 6000=10:0.2:8:20:61.8.The prepared albendazole ivermectin powder has good dispersibility in water and meets the sedimentation volume ratio requirements of dry suspensions.According to the quality standards of albendazole ivermectin powder,it is qualified,and the uniformity of low content ivermectin content meets the requirements.It can achieve the mixing and drinking water administration of insoluble drug albendazole.Sealed storage,long-term test for 24 months,with almost no changes in character and appearance;The weight loss on drying increased from 2.4%to 2.6%;The content of albendazole decreased from 99.2%to 97.3%;The content of ivermectin decreased from 100.2%to 97.0%,with a decrease of no more than 10%of the drug's labeled content,which meets the regulations.The formula of this albendazole ivermectin powder is reasonable,the process is simple and scientific,the operation is simple,the product quality is qualified and stable,and the validity period is tentatively set at 2 years.