Toxicological safety evaluation of Qiguiyin formula in rats at the treatment phase and recovery phase

Abstract

Ethnopharmacological relevanceQiguiyin, a hospital preparation of traditional Chinese medicinal formula, is a combination of Astragalus hamosus L., Angelica sinensis (Oliv.) Diels, Lonicera sempervirens L., Artemisia annua L., and Polygonum cuspidatum Siebold & Zucc. at a ratio of 12:3:3:2:2. It has been used to treat severe pneumonia caused by drug-resistant bacteria in clinical practice, while studies on its toxicological safety are rare in the literature. Aim of the studyIn the present study, we aimed to develop a new application of Qiguiyin according to the general research routine of traditional Chinese medicine (TCM), and the toxicological effects of the Qiguiyin formula at the treatment phase and recovery phase were also evaluated. Materials and methodsThe rats were administered with the Qiguiyin formula at 10, 30, and 50 times of the corresponding dosage in humans for 13 consecutive weeks. During 13 weeks of the treatment phase and 4 weeks of the recovery phase, the general signs of toxicity and mortality were monitored daily, and the body weight and food consumption were determined every week. Moreover, the hematology, biochemistry, urine, organ weights, and histopathology were analyzed, and the reproductive system was examined at the end of the treatment phase or recovery phase, respectively. ResultsThe toxicological results showed no deaths and no changes in general behavior. Moreover, there was no clinically significant effect of the Qiguiyin formula on body weight or food consumption in rats. Although the Qiguiyin formula resulted in some changes in hematological, biochemical, and urinary indexes, these alterations were not related to the treatment because they remained within normal ranges throughout the 17 weeks. Besides, the main organs were not affected basically. All the above-mentioned results showed no gender difference. Furthermore, a clinical dosage of 50 times of the Qiguiyin formula did not affect the reproductive system of female rats, while it could lead to atrophied seminiferous tubules in two out of 10 male rats. However, such abnormality could not be found at the end of the recovery phase. ConclusionsOverall, the Qiguiyin formula could be used safely. The administration at doses of less than 1000 g/day for 13 weeks showed no distinct toxicity or side effects.