Formulation Optimization and Safety Evaluation of the Compound Fuzhuan Tea Bag
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Abstract:
A compound fuzhuan tea bag was developed by using fuzhuan tea as the main raw material, with other medicinal and edible homologous plant materials such as hawthorn, chamomile and dried tangerine peel as the excipients. The optimal formula was obtained through orthogonal tests and sensory evaluation. The safety of the compound tea was assessed on the basis of acute toxicity tests, and through genetic toxicity tests including the Ames test, mammalian erythrocyte micronucleus test and in vitro mammalian cell chromosome aberration test. The results showed that the optimum formula was obtained through orthogonal experiments: 13.16% hawthorn, 13.16% dandelion, 26.32% fuzhuan tea, 15.79% mint leaves, 7.89% fennel, 13.16% tangerine peel and 10.53% chamomile. The optimal formula contained flavonoids 4.83%, polyphenols 11.59%, amino acids 4.12%, water extracts 37.56%, which were slightly higher than those of the combinations with the top 5 scores in the orthogonal test. The maximum tolerated dose of the compound fuzhuan tea bag in mice was higher than 21.285 g/ (kg·bw), which was 507 times as much as the recommended dose for humans, thus indicating non-toxicity. In addition, the results of the Ames test and in vitro mammalian chromosome aberration tests were negative (p>0.05) in the absence and presence of S9 mixture. The extract of the compound fuzhuan tea had no micronucleus-inducing effect on polychromatic erythrocytes of bone marrow in mice. These results showed that the compound fuzhuan tea had no genotoxicity and is safe for intake.
