银杏内酯注射液-中国药品标准.DOCVIP

银杏内酯注射液血管刺激性作用研究 张德波,罗洁 郑娇娇 （成都市药品检验所, 成都 610045） [摘要] 目的：对银杏内酯注射液血管银杏内酯注射液血管银杏内酯注射液银杏内酯注射液?ml-1浓度对兔血管有刺激作用，0.5mg?ml-1、0.2mg?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：银杏内酯注射液银杏内酯注射液血管vascular irritation of Ginkgolide?Injection Zhang Debo, Luo Jie, Deng Sha, Zheng Jiaojiao, He Shu (Chengdu Institute for Drug Control, Chengdu 610045) Abstract: 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-1 had the irritation on the rabbits’ vessels but the diluted solution of Ginkgolide Injection 0.5 mg?ml-1 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. Key words: Ginkgolide?Injection; vascular irritation; specimen fixing solutions; concentrations of test solution; diluents; recovery. 银杏内酯注射液主要成分为白果内酯、银杏内酯A、银杏内酯B和银杏内酯C等，辅料为甘油、乙醇具有活血化瘀，通经活络作用?ml-1，高于临床用药浓度0.2mg?ml-1，在检查时可能形成刺激性作用，同时标准中未设恢复期观察，会造成对药品的过分严格要求，因此为了进一步完善标准中的刺激性检查项，考察查银杏内酯注射液银杏内酯注射液（，批081508100815100208150706）由成都百裕制药股份有限公司提供，本品临床用药浓度为0.2mg?ml-1，用0.9%氯化钠注射液或5%葡萄糖注射液稀释配制。 1.2动物 日本大耳白实验兔，普通级，体重1.9～2.5kg，♀♂兼用，♀无孕，由四川省实验动物专委会养殖场提供，生产许可证号：SCXK(川)20