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引用本文:覃瑶,阳勇,龚晓丽,李紫薇,赵嘉将,罗维早.七叶皂苷钠微乳注射剂的安全性及药效学研究[J].中国现代应用药学,2013,30(10):1043-1046.
QIN Yao,YANG Yong,GONG Xiaoli,LI Ziwei,ZHAO Jiajiang,LUO Weizao.Study on the Safety and Pharmacodynamics of Sodium Aescinat Micro-emulsion Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(10):1043-1046.
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七叶皂苷钠微乳注射剂的安全性及药效学研究
覃瑶,阳勇,龚晓丽,李紫薇,赵嘉将,罗维早
1.太极集团有限公司,重庆 401147;2.重庆市中药研究院,重庆 400065;3.四川省中医药科学院中医研究所,成都 610041;4.重庆医科大学,重庆 400016
摘要:
目的 对市售七叶皂苷钠粉针及自制七叶皂苷钠微乳注射剂的安全性和疗效进行对比研究。方法 以新西兰家兔为试验用动物,进行溶血试验和血管刺激性试验,对用药安全性进行考察;对二甲苯致小鼠耳肿胀及耳廓毛细血管通透性增加的抑制作用进行考察,作出初步药效学评价。结果 市售粉针和自制微乳剂均有轻微的溶血和一定的刺激性,组间无明显差别;高、低剂量的七叶皂苷钠粉针及微乳注射剂对二甲苯所致小鼠耳肿胀及耳廓毛细血管通透性增加均有明显的拮抗作用,其中七叶皂苷钠微乳注射剂的拮抗作用更为明显。结论 市售粉针剂和自制微乳注射剂均存在一定的静脉注射安全性风险,两者抗炎消肿作用明显,七叶皂苷微乳注射剂疗效更为显著。
关键词:  注射用七叶皂苷钠  微乳剂  安全性  有效性
DOI:
分类号:
基金项目:国家自然科学基金(81073062);重庆市中药产业“重构提升”行动科技攻关项目
Study on the Safety and Pharmacodynamics of Sodium Aescinat Micro-emulsion Injection
QIN Yao1,2, YANG Yong3, GONG Xiaoli4, LI Ziwei5, ZHAO Jiajiang1, LUO Weizao1,2
1.Taiji Group, Chongqing 401147, China;2.Chongqing Institute of Traditional Chinese Medicine, Chongqing 400065, China;3.hongqing Institute of Traditional Chinese Medicine, Chongqing 400065, China;4.Sichuan Academy of Chinese Medicine Sciences, Chengdu 610041, China;5.Chongqing Medical University, Chongqing 400016, China
Abstract:
OBJECTIVE To undertake a contrastive study on safety and pharmacodynamics of sodium aescinat powder injection and micro-emulsion injection. METHODS New Zealand rabbits were chosen as experimental animals for hemolysis and vascular stimulation tests, and its safety for therapy was probed. Investigate the inhibitory effect on xylene-induced mouse ear edema and capillary permeability-increasing, and a preliminary pharmacodynamics evaluation was made. RESULTS Both of sodium aescinat powder injection and micro-emulsion injection had slight hemolysis and stimulation, there was no evident difference between the two groups; both groups of high dose and low dose sodium aescinat powder injection and micro-emulsion injection had remarkable restrictive effect on mouse ear edema and capillary permeability-increasing, the antagonistic action of micro-emulsion injection was more apparent. CONCLUSION Both of sodium aescinat powder injection and micro-emulsion injection have a certain intravenous security risk, and they also have significant anti-inflammatory effects, the anti-inflammatory effects of sodium aescinat micro-emulsion injection is more apparent.
Key words:  sodium aescinat for injection  micro-emulsion for injection  safety  validity
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