6%吡喹酮注射剂的稳定性与刺激性试验研究

Observation on the stability and irritation of praziquantel injection

抗血吸虫药 6%吡喹酮非水溶液注射剂在室内避光自然温度条件下保存 12个月 ,颜色稳定性好 ,没有加深变黄的现象 ,但在不避光条件下 ,药液放置 6个月后明显氧化变黄。加速试验表明 ,2 5℃时 ,其注射剂的降解速率常数logK2 5℃ 为 - 5 972 8h-1,T1/2 为 5 5年。肌注刺激性试验表明 ,兔和牛肌注部位没有炎症和坏死病理变化 。

The stability and irritation of the widespectrum antischistosomal,praziquantel injection were studied in this paper.Accelerated tests and stability experiments on exposure to light were employed.The results indicated that the injection didn't turn colour after storage at room temperature in tightly closed lightproof containers for 12 months,but turned into dark yellow after storage on exposure to light at room temperature for 6 months.Accelerated tests at a flexible heating experiments showed that the degradation rate constant log K 25℃ of the injection was -5.9728/h and shelf life of the injection was 5.5 years in the tighly colsed light proof containers.Irritation tests indicated that there were no any pathological changes of inflammation and necrosis in the administration site after a singte intramuscular administration in cattle and rabbits.\;