Abstract: Objective: Royal jelly complex capsule is a kind of constituent of herbal medicine and royal jelly compounded preparation of tradition. It was necessary to make the toxicological assessment. Methods: The acute toxicity LD 50 test in mice, micronuclei test of bone marrow cell and sperm shape abnormality test and chromosome malformation analysis of testicle reproductive cell in mice, Ames test, 30 days feeding test in mice. Result: According to the result of acute toxicity LD 50 test in mice, the royal jelly complex capsule has not acute toxicity. All three geno toxicity tests had negative. The developmental toxicity and embryo toxicity had also not been found in teratogenicity test.Abnormal phenomena had not been found in 30 days feeding test. Conclusion: Royal jelly complex capsule is safe in using.

Key words: royal jelly complex capsule, safety, toxicity tests