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参丹芎注射液的安全性试验研究 被引量:6

Safety evaluation of Shendanxiong Injection
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摘要 目的观察参丹芎注射液是否具有血管刺激性、溶血和过敏性反应。方法家兔耳缘iv给予参丹芎注射液8mL/kg,每天给药1次,连续给药5d,停药48h后对注射部位进行病理组织学检查;0.1~0.5mL参丹芎注射液在4.5~4.9mL兔红细胞混悬液中放置0.25~3h,观察对兔红细胞悬液的溶血及有无红细胞凝聚作用;豚鼠隔日ip给予0.5mL参丹芎注射液,连续注射3次,分别于末次致敏后第14和21天iv给予1.0mL参丹芎注射液进行激发,观察豚鼠30min内是否出现过敏反应。结果参丹芎注射液对家兔耳缘静脉血管内皮没有损伤和刺激作用;兔红细胞溶血和凝聚作用阴性;豚鼠全身主动过敏反应阴性。结论参丹芎注射液无血管刺激性、体外溶血性和全身主动过敏性反应。 Objective To observe whether Shendanxiong Injection (SI) has vascular stimulation, bemolyzation, and sensitization. Methods Rabbits were iv administrated with SI (8 mL/kg, once daily continuously for 5 d), and histopathlogic examination of injection site was carried out after 48 h of drug withdrawal. SI (0.1-0.5 mL) was placed in rabbit erythrocyte (4.5-4.9 mL) in vitro for 0.25-3 h, and hemolyzation and agglutination of rabbit erythrocyte were observed. Guinea pigs were ip administrated with SI (0.5 mL) every other day for three times successively, and on Day 14 and 21 after the last sensitization 1.0 mL of SI was iv administrated to arouse the reaction. Results It showed that SI had no vascular irritation or injury effect on rabbit vascular endothelial cells, and no evidence of hemolyzation and aggregation on rabbit erythrocyte in vitro or allergic reaction on guinea pig in vivo were observed. Conclusion There is no vascular stimulation on rabbit vascular endothelial cells, no sensitization on guinea pig in vivo, or no hemolyzation oragglutination on rabbit red blood cells in vitro.
出处 《药物评价研究》 CAS 2012年第2期103-105,共3页 Drug Evaluation Research
基金 国家创新药物资助项目(2009ZX09103-445)
关键词 参丹芎注射液 血管刺激 溶血 全身主动过敏 安全性试验 Shendanxiong Injection (SI) stimulation of vascular hemolysis active systemic anaphylaxis safety experiment
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