Long-term toxicological studies on the Chinese medicine 2036 Specialty-Qiangxin recipe in rats

Abstract

Context

The traditional medicine 2036 Specialty-Qiangxin recipe (2036S-QXR) has been widely used in China to improve cardiac function, prevent stroke, and strengthen the immune system. However, its long-term toxicity remains unknown.

Objective

The present study evaluates the long-term toxicity of 2036S-QXR in rats.

Materials and methods

2036S-QXR (0.6, 1.2, and 2.4 g/kg body weight per day) was orally administered for 26 weeks to Wistar rats, while the rats in the control group received distilled water. The effects on urinary, hematological, biochemical, and histopathological parameters were investigated during the study period.

Results

No significant changes in all tested parameters were observed in the 0.6 and 1.2 g/kg groups, compared with the control group (p < 0.05). Higher levels of alanine aminotransferase (46.00 ± 12.85 vs. 25.40 ± 3.36) and aspartate aminotransferase (152.40 ± 32.52 vs. 111.40 ± 18.78) were observed after 13 weeks in the female rats in the 2.4 g/kg group compared with the control group (p < 0.05), but these returned to the control levels after the recovery period (p > 0.05). Several cases displayed the presence of urine protein (3/7 males and 3/7 females) and mild lesions in the kidney (10/20) and thymus (5/20) in the 2.4 g/kg group, without significant changes compared with the control group (p > 0.05).

Discussion and conclusions

The present study shows that 2036S-QXR does not cause long-term toxicity, supporting its therapeutic use. To further determine the optimal doses, future studies should test more doses and include more animals in each group.

Keywords:

• Traditional medicine
• Rhodiola rosea
• Ganoderma lucidum spore
• grape seeds
• adverse effects

Disclosure statement

The authors have declared no conflict of interest.

This work was supported by the National Natural Science Foundation of China (Nos. 82072163, 81272080, and 81000835); by the Natural Science Foundation of Guangdong Province (No. 2016A030313797); by the Science and Technology Planning Project of Shenzhen Municipality (Nos. JCYJ20180305123654620 and JCYJ20120613101917373); by SZU Top Ranking Project (No. 86000000210); and by Shenzhen ‘Sanming’ Project of Medicines (No. SZSM20150602).

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article.