Safety Evaluation Of Functional Red Kojic Rice

Functional red kojic rice was widely applied to the fields of health food and the development and use of drug for its abundant physiological activator, especially for Monacolin K that it had blood-lipid lowering function. However, the vast majority of Monascus purpureus produce citrinin that was mycotoxin. Then the safety of functional red kojic rice was called in question.Using70%ethanol to extract functional red kojic rice during the preliminary treatment, and then determined the content of Monacolin K and citrinin in functional red kojic rice extract by HPLC. According to the rules of GB15193.1-2003《Procedures for toxicological assessment of food》, this text selected four tests, acute toxicity test、Salmonella typhimurium test (Ames test)、bone marrow cell micronucleus test and mice sperm abnormality test to study acute toxicity and genetic toxicity of functional red kojic rice extract. The text had used many basic research in order to get preliminary result for profound research about functional red kojic rice.Acute toxicity test adopted the method of maximum tolerance dose, using the male and female Kunming mice(km mice). And in the test,the km mice were fed on functional red kojic rice extract that its maximum concentration of15g/kg in the treatment group and fed on distilled water in the control group. The result showed there was no any toxicity symptom and death in mice. The data analysis of body weight and liver weight displayed there was no significant differences in different sexes and groups. The functional red kojic rice extract was no acute toxicity.Using Ames test、bone marrow cell micronucleus test and mice sperm abnormality test to study genetic toxicity, including vivo test and vitro test.In the Ames test, it selected strains TA97、TA98、TA100、TA102to detect gene poisonousness, such as frameshift mutation n base pair substitution. In the test, it set experiment groups of different doses of functional red kojic rice extract and control groups of citrinin. The doses of functional red kojic rice extract set as40μg/plate、200μg/plate、1000μg/plate、5000μg/plate and citrinin set as0.2μg/plate、1.0μg/plate、5.0μg/plate、25.0μg/plate to investigate mutagenicity. The data analysis had showed that both functional red kojic rice extract and citrinin failed to cause genie mutation. The result were both negative.In vivo test, bone marrow cell micronucleus test can detect the mutagenicity in chromosome of somatic cell and mice sperm abnormality test can detect the mutagenicity in chromosome of germ cell. In bone marrow cell micronucleus test, it had set treatment groups、negative group and positive group of both sexes km mice to observe the micronucleus frequency (MCNF). In treatment groups, the doses of functional red kojic rice extract were2.5g/kg、5g/kg and10g/kg. The negative contrast was distilled water and the positive contrast was cyclophosphamide with dose of40mg/kg. According to count the number of micronucleus in1000polychromatic erythrocyte (PCE), the result revealed that the MCNF of treatment groups and negative control group were no significant difference, and it had obvious difference between treatment groups and positive group. The test result showed the functional red kojic rice extract had no mutagenicity to chromosome in somatic cell. In mice sperm abnormality test, it selected adult male mice and set treatment groups、 negative group and positive group to observe the rate of teratosperm from1000sperm. The doses of functional red kojic rice extract were2.5g/kg、5g/kg and10g/kg in treatment groups, and the negative contrast was distilled water and the positive contrast was cyclophosphamide with dose of40mg/kg. The result showed that the treatment groups and negative group had no significant difference and had obvious difference compared to positive group. So the functional red kojic rice extract had no mutagenicity to chromosome in germ cell.In conclusion, the functional red kojic rice extract had no acute toxicity and genetic toxicity according to the four tests. The functional red kojic rice was safety.