注射用七叶皂苷钠体外溶血作用试验研究

目的：探讨不同种类实验动物血细胞对七叶皂苷钠体外溶血活性的影响以及比较国内外同类品种体外溶血活性。方法：参照《中国药典》2005年版一部“溶血与凝聚”检查法。结果：用兔血细胞考核的9批产品，其中2批出现红细胞微溶无凝聚，采用羊血细胞则均未出现红细胞溶血与凝聚；用兔、羊、牛血细胞分别测得本公司2批产品的溶血指数（完全溶血浓度）为1／20．8万、1／15．6万、1／15．6万以上；用成年黄牛血细胞测得七叶皂苷钠国家对照品溶血指数为1／10万，略高于德国Reparil（1／20万）。结论：应采用同一来源的一种常用动物--家兔血细胞检测药品体外溶血活性以及在相同条件下检测国内同类品种体外溶血活性不高于国外。

Experimental Study on Hemolysis of Sodium Aescinate for Injection in vitro

Objective： To discuss the effects of different types of laboratory animals＇ blood cells to hemolytic activity of sodium aescinate in vitro, and to compare hemolytic activity in vitro of the same kind of medicine home and abroad. Method： The reference was the ＂hemolytic and cohesion＂ test in Part One of 2005ed ＂Chinese Pharmacopoeia＂. Result： Nine batches of rabbit blood cells were examined. Two batches of them were dissolved slightly without cohesion. And sheep blood cells examined were not dissolved or agglomerated. The hemolytic indexes （ concentration of total hemolytic） of two batches of our products examined with rabbit, sheep, cow blood cells were more than 1/208 000, 1/156 000, 1/156 000 seperately. The hemolytic index of the reference substance of sodium aescinate examined with adult cattle was 1/100 000, slightly higher than （ 1/200 000） of Germany Reparil. Conclusion： It is better to use a common animal from the same source-rabbit blood cells to examine the drug＇ s hemolytic activity in vitro. And in the same condition, the hemolytic activity in vitro of the internal medicine is not higher than the same kind of medicine abroad.