摘要
目的观察注射用盐酸槐定碱是否具有血管刺激性、溶血和过敏性反应。方法家兔耳缘静脉注射注射用盐酸槐定碱8．3ml／kg，qd×5d，停药96h后对注射部位做病理组织学检查；体外不同浓度的注射用盐酸槐定碱0．1～0．5ml在5ml免红细胞混悬液中放置0．25—24h，观察对免红细胞悬液的溶血作用及有无红细胞凝聚作用；给豚鼠隔日腹腔注射不同浓度注射用盐酸槐定碱0．5ml，连续注射3次，分别在第1次注射后第14天及21天从静脉给予注射用盐酸槐定碱1ml，观察30min内是否出现过敏反应；取大鼠，背部皮内注射含IgE的抗血清，24h后静脉注射含注射用盐酸槐定碱的0．8％伊文思兰溶液1ml攻击，30min后处死动物，观察注射点皮肤蓝色反应斑点直径。结果注射用盐酸槐定碱对家兔血管内皮没有损伤和刺激作用；对兔红细胞没有致溶血作用和凝聚作用；豚鼠未出现过敏反应。结论注射用盐酸槐定碱用药血管没有刺激性反应，无溶血及红细胞凝聚现象，对豚鼠无致敏作用且大鼠无同种被动皮肤过敏作用。制剂有关安全性检测结果符合新药申报要求。
Objective To observe whether Sophoridine Hydrochloride for Injection has vascular stimulation, hemolyzation, agglutination and sensitization. Methods The vascular stimulative assay of Sophoridine Hydrochloride for Injection was injected to rabbit at the dose of 8.3 mg·kg^-1 , qd for 5 d. Pathology histology examine of injection place after stoping remedy 96 hours was made. Hemolyzation or agglutination of it in vitro was set at the concent ration of 0. 1 -0. 5 ml for 0. 5 - 24 h. The allergic reaction on guinea pig in vivo and rat in skin were performed. Results It showed that the Sophoridine Hydrochloride for Injection had no vascular irritation and injury effect on rabbit vascular endothelial cell. No evidences of hemolyzation and aggregation on rabbit erythrocyte in vitro,and no allergic reaction on guinea pig in vivo and rat skin were observed. Conclusion There is no vascular stimulation on rabbit vascular endothelial cell and sensitization on guinea pig in vivo, sensitization on rat in skin, and no hemolyzation oragglutination on rabbit red blood cells in vitro. These results of preparation safety will fit the new drugs application requirements.
出处
《时珍国医国药》
CAS
CSCD
北大核心
2007年第8期1890-1891,共2页
Lishizhen Medicine and Materia Medica Research
