[Study on the toxic reaction induced by single dose of qingkailing injection].

Objective: To study the toxic reaction induced by Qingkailing Injection.

Methods: Kunming mice were injected single dose of Qingkailing Injection via tail vein and observed for 14 days to test the toxic reaction of the drug. According to Chinese Pharmacopoeia, hemolysis tests were conducted on the injections of different lots and each ingredient of the injection.

Results: Toxic reaction induced by single dose of injection--with dose increasing,mice quickly showed different responses such as hypodynamia, convulsion, syncope and even death after injection. In the high dose group, blood routine detection showed that mice have lower counts of RBC, WBC and lower content of hemoglobin; The pulmonary pathological sections of dead mice showed significant hyperemia. And there were no significant difference in the contents of serum electrolyte (K+, Na+, Ca2+) between normal saline control group and Qingkailing injection group. Hemolysis test in vitro--Honeysuckle extraction (significantly) and gardenia extraction which were components of Qing-kailing injection caused hemolysis in certain dose; While gardenia, pearl shell and isatis root extraction caused RBC agglutination. With higher concentration, the Qingkailing injections of different lot caused different degree of hemolysis. There was no significant difference in the hemolysis test in vitro between the group of Balb/C mice which were sensitized by Qingkailing injection or not.

Conclusion: In clinical practice some adverse reactions induced by Qingkailing injection occurred concomitantly with acute hemolysis within vessels, which might be caused by honeysuckle and gardenia. And the hemolysis was independent of allergy.