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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。
Objective: To investigate the effect of different kinds of experimental animals’ blood cells on the hemolysin activity of sodium aescinate in vitro and to compare the in vitro hemolysis activity of the same species at home and abroad. Methods: According to “Chinese Pharmacopoeia” 2005 edition of a “hemolysis and agglutination ” test. RESULTS: Nine batches of rabbit blood cells were used for evaluation. Two batches of erythrocytes were found to be slightly soluble and nonagglutinating. No hemolysis and aggregation of erythrocytes were observed in sheep blood cells. The haemolysis of the two batches of products of the Company was measured using rabbit, sheep and bovine blood cells respectively. Index (complete hemolytic concentration) 1 / 208,000, 1 / 156,000, 1 / 156,000 or more; measured with adult cattle hematocytes sodium aescinate national reference substance hemolysis index of 1/10 million, slightly higher than the German Reparil ~ (?) (1/20 million). CONCLUSIONS: Hemolysis activity of drugs should be tested in vitro by rabbit blood cells, which is a kind of common animal from the same source, and the in vitro hemolysis activity of the same kind of domestic species should not be higher than that of other countries under the same conditions.