Safety and Toxicological Assessment of Allantoin Extract from Cistanches Herba / 中国实验方剂学杂志

ABSTRACT

Objective: To evaluate the safety of allantoin extract from Cistanches Herba,so as to provide scientific support for subsequent utilization and development of allantoin extract from Cistanches Herba.Method: According to the national standard procedures and methods in food safety and toxicological evaluation,a series of toxicological studies on allantoin extract from Cistanches Herba were conducted,including genetic toxicity and subacute toxicity tests.Result: In the Ames test,with or without mammalina liver microsomal enzymes (S9),allantoin extract from Cistanches Herba in 40,200,1 000,5 000 μg·dish-1 dose range for four bacteria showed no dose-dependent increase.In the micronucleus test,there was no statistically significant difference among each dose group and the negative control group.In the test of mouse sperm aberration,there was no significant difference in the sperm aberration rate among the allantoin extract group and the negative control group.The results of three genotoxicity tests were all negative,indicating no genotoxicity in allantoin extract.The results of 30 days test showed no death and abnormal clinical sign in rats of control group and each dose group (1.100,0.550,0.275 g·kg-1).The body weight,food intake,weekly and total food utilization,weight increment,organ/body ratios,blood biochemical indexes and blood routine indexes had no significant difference among the control group and dose groups.There was no abnormal pathological change in heart,liver,spleen,lung,kidney and testicle of rats in treatment group.Conclusion: Allantoin extract from Cistanches Herba is a non-toxic substance without any genetic toxicity but with a high edible safety.This study provides scientific experimental basis for its safety.