苦参碱葡萄糖注射液安全性试验研究

目的:观察苦参碱葡萄糖注射液的制剂安全性.方法:根据国家药品监督管理局颁布的新药审批办法的规定,取家兔红细胞进行苦参碱葡萄糖注射液溶血性试验;取豚鼠经胫静脉给药进行致敏和激发攻击,进行全身过敏性实验;取家兔进行耳缘静脉滴注,每天1次,连续7 d,进行血管刺激性试验.结果:苦参碱葡萄糖注射液在体外对家兔红细胞无溶血作用,对豚鼠不引起过敏性反应,对家兔耳缘静脉不产生刺激性.结论:苦参碱葡萄糖注射液是一种安全的注射用制剂.

Experimental Study on Preparation Security of Matrine Glucose Injection

Objection: To observe the preparation security of Matrine Glucose Injection (MGI). Method: According to the Examining and Approving Method for New Drug promulgated by the State Supervising and Administering Bureau of Drugs, the rabbit erythrocytes were collected for detecting the haemolytic effects of MGI. The whole body hypersensitivity in Guinea pigs was induced by intravenous injection of MGI through tibial vein,and its stimulation to blood vessel was conducted by intravenously dripping MGI through the vein at the border of rabbit ear, once a day, for 7 days. Result: MGI had no haemolytic effects on rabbit erythrocytes in vitro, and it could not induce the whole body hypersensitivity in guinea pigs, and its stimulation to the vein at the border of rabbit ear could not be found. Conclusion: MGI is a secure preparation for intravenous injection.