Comparative Study on New Method and Traditional Methods for Hemolysis Test of Qingkailing Injection

OBJECTIVE:To find out a more objective method to reflect hemolysis of Qingkailing injection. METHODS:Hemolysis situation of 18 batches of Qingkailing injection from 9 manufacturers were evaluated through the in vivo hemolysis method and in vitro naked eye observation experiment. RESULTS:Hemolysis test of 18 batches of test samples were negative by in vitro naked eye observation method. Hemolysis test of 15 batches of test samples were negative by in vivo hemolysis method,and 3 batches of test samples were suspected as positive. The consistent rate of in vivo and in vitro hemolysis test was 83.3%. CONCLUSIONS:There is an correlation between in vivo hemolysis test and results of in vitro naked eye observation method for Qingkailing injection,and in vivo method is better than that of in vitro method.