缓释复方免疫增强剂有效药物释放量及安全性试验

将100只14日龄健康肉杂仔鸡随机分成A、B、C、D、E 5个试验组,每组20只鸡,A、B、C、D 4组为试验组,E组为对照组。A、B、C 3组试验鸡每只分别投服批号为0308、0312、0402的缓释复方免疫增强剂1粒,进行有效药物释放量测定试验,试验结果表明,药物投服后日均磨损量20d前为6.2~6.7 mg,30 d前为6.0~6.3 mg,日均药物有效释放量为2.40~2.52 mg,经方差分析,批间差异不显著(P0.05),均在有效剂量之间,药物的有效释放期均在30 d以上。D组试验鸡每只投服缓释复方免疫增强剂3粒,进行有效药物安全性试验,试验结果表明,仔鸡投服后食、饮欲正常,精神状态良好,与对照组鸡相比未发现任何不良反应,从而说明该缓释制剂在鸡体内是安全有效的。

Study on Accumulative Release and Safety of Sustain-Released Compound Immunoenhancer

The experiment was conducted to evaluate the accumulative release and safety of the sustain-released compound immunoenhancer.Total 100 fourteen-day-old chicks were randomly divided into five groups（A,B,C,D and E）.Group A,B,C,D were test groups while E was control group.Chicks of A,B,C received respectively three different batches of the drug（No.0308,No.0312 and No.0402） for determination of accumulative release,one pill per chick.Each chick of D received three pills to test the safety of the drug.The results showed that the wear loss of the drug varied from 6.2mg to 6.7mg during the first 20 days after taking medicine,and that of the drug varied from 6.0mg to 6.3mg during the first 30 days.Daily average accumulative release varied from 2.40mg to 2.52mg.There was no significant differences between treatments of the three batches of the drug by analysis of variance in yield（P0.05）.The effective period of the drug lasted over 30 days.The chicks of D group were healthy and there was no harmful reactions compared with the control chicks.It indicated that the drug was safe and effective.