七叶皂苷钠微乳注射剂的安全性及药效学研究

Study on the Safety and Pharmacodynamics of Sodium Aescinat Micro-emulsion Injection

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。

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 pharrnacodynamics 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.