注射用水溶性维生素安全性试验报告

The Test Report of the Reliability of Water-Soluble Vitamin for Injection

目的 :对注射用水溶性维生素进行血管刺激性、肌肉刺激性、溶血性及全身过敏性试验 ,以此评价其用药的安全性。方法 :在血管刺激性试验中 ,主要观察 4只家兔分别连续 5天注射水溶性维生素及生理盐水后的变化。在肌肉刺激试验中 ,主要观察 4只家兔分别注射水溶性维生素及生理盐水后 4 8h的变化。在溶血性试验中 ,观察本品在 4h内有无溶血和凝集现象。在全身过敏性试验中 ,两组豚鼠隔日 3次分别腹腔注射水溶性维生素和生理盐水后 ,于首次给药后第 14日和 2 1日分别静脉注射水溶性维生素和生理盐水 ,观察攻击后 15min内动物的变化。结果 :未发现水溶性维生素对家兔耳缘静脉有明显的刺激作用 ,但对家兔股四头肌有一定的刺激作用 ,家兔无溶血现象。水溶性维生素对豚所有动物均未见过敏反应 ,而 4 %鸡蛋清阳性对照组动物均出现过敏反应。结论 :注射用水溶性维生素的动物试验结果表明其安全可靠。

Objective: To evaluate the reliability of it by testing the vessel stimulation, muscle stimulation and hypersensitivity of total body. Methods: Four rabbits were observed at 48h after injection water-soluble vitamin and saline. In the haemolyticus tests, hemolysis and coagulation were mainly observed. Two groups of cavy were injected by water-soluble vitamin and saline differently in abdominal cavity in 3 times, the last two were 14d and 21d after first medication. The action of animal at 15 min after injection was observed. Results: The water-soluble vitamin has no marked stimulation to ear vein of rabbit, but some stimulation to quadriceps femoris without hemolysis in rabbit. The 4% albumen group has allergic reaction as contrast. Conclusion: The water-soluble vitamin injection was safety and reliable based on the animal experiment.