银杏内酯注射液血管刺激性作用研究

Study on the vascular irritation of Ginkgolide Injection

目的:对银杏内酯注射液血管刺激性进行研究。方法:考查不同固定剂、不同浓度供试液、不同稀释剂对银杏内酯注射液血管刺激性作用的影响;考察停止给予银杏内酯注射液14 d后血管刺激恢复情况。结果:FAA固定液对血管刺激性的判断有一定影响;使用10%福尔马林溶液或10%福尔马林生理盐水溶液作为固定剂较好;银杏内酯注射液稀释成1.0 mg·mL^(-1)浓度对兔血管有刺激作用,0.5、0.2 mg·mL^(-1)浓度对血管未见刺激作用;0.9%氯化钠注射液、5%葡萄糖注射液两种稀释剂配制药物对血管刺激性无影响;停药14 d后血管刺激作用能部分恢复。结论:银杏内酯注射液现行标准中的"刺激性试验"检查应当修改。

Objective： Study on the vascular irritation of Ginkgolide Injection. Methods： It was investigated that the different specimen fixing solutions, concentrations of the test solution and diluents had the impacts on the vascular irritation of Ginkgolide Injection and whether the vascular function could be recovered after the use of Ginkgolige Injection was stopped for 14 days. Results：The fixing solution of FAA interfered with the judgment of vascular irritation. The 10% Formaldehyde Solution or 10% Formaldehyde Sodium Chloride Solution were the better fixing solutions. The diluted solution of Ginkgolide Injection 1.0 mg · mL-l had the irritation on the rabbits＇ vessels but the diluted solution of Ginkgolide Injection 0. 5 mg · mL-l and 0. 2 mg · mL-1 had no irritation on the rabbits＇ vessels. The diluents of 0. 9% Sodium Chloride solution and 5% Glucose solution had no impact on the vascular irritation. The vascular function could be recovered after the use of Ginkgolige Injection was stopped for 14 days. Conclusion：The test of vascular irritation in the Ginkgolide Injection specification should be modified.