Safety Evaluation for Acute and Chronic Oral Toxicity of Maha Pigut Triphala Contains Three Medicinal Fruits in Sprague-Dawley Rats

Abstract

Maha Pigut Triphala is the herbal mixture of three fruits consisting of T. bellirica, T. chebula, and E. officinalis also known as P. emblica. Humans regularly eat the fresh fruits of these plants on a daily basis. Maha Pigut Triphala is one of the widely known herbal medicinal formulas used in traditional Thai medicine. Besides studying pharmacological properties, attention should also be paid to the safety and toxicity studies of herbal medicines. The objective of the present study was to evaluate the acute and chronic oral toxicity of Maha Pigut Triphala (2:1:3) in Sprague-Dawley rats. A single dose of Maha Pigut Triphala at a concentration of 5000 mg/kg body weight was administered orally to female rats in the acute oral toxicity study. In the chronic oral toxicity study, male and female rats were treated with various concentrations of Maha Pigut Triphala (600, 1200, and 2400 mg/kg body weight) once daily for 270 consecutive days. The presence of abnormalities in the symptoms and behavior of the rats were observed and recorded throughout the experiment. Additionally, body weight, organ weight, and mortality were recorded. At the end of the study, blood samples were collected for hematological and blood chemistry analysis, while the internal organs were evaluated for gross pathological and histopathological changes. The acute oral toxicity study revealed no mortality and abnormal symptoms or behavior in Maha Pigut Triphala-treated rats. Moreover, gross pathological and histopathological findings did not reveal any abnormalities in the internal organs. In the chronic oral toxicity evaluation, although there were negligible changes in body weight, organ weight, and hematological and blood chemistry parameters in rats treated with Maha Pigut Triphala for 270 days, no behavioral or gross pathological and histopathological abnormalities were observed. Overall, the results of this study demonstrate that Maha Pigut Triphala (2:1:3) neither causes acute nor chronic oral toxicity in rats, proposing the safety of this herbal formula in animals prior to human trials and use.

Keywords: Emblica officinalis; Maha Pigut Triphala; Phyllanthus emblica; Sprague-Dawley rats; Terminalia bellirica; Terminalia chebula; acute oral toxicity; chronic oral toxicity; safety.

Figure 1

TLC chromatograms of compounds after being visualized under 254 nm (A) and 366 nm (B) UV light or sprayed with anisaldehyde-sulfuric acid (C) and phosphomolybdic acid (D); 1 = ellagic acid, 2 = aqueous extract of T. chebula, 3 = raw material of T. chebula, 4 = aqueous extract of T. bellirica, 5 = raw material of T. bellirica, 6 = aqueous extract of E. officinalis, 7 = raw material of E. officinalis, 8 = gallic acid, 9 = protocatechuic acid.

Figure 2

Body weight of female rats in the acute oral toxicity study of Maha Pigut Triphala. Results are expressed as mean ± S.E.M., n = 5.

Figure 3

Body weight of female rats in the chronic oral toxicity study of Maha Pigut Triphala. Results are expressed as mean ± S.E.M., n = 10, n = 5 (satellite group). * p < 0.05 compared with the control group.

Figure 4

Body weight of male rats in the chronic oral toxicity study of Maha Pigut Triphala. Results are expressed as mean ± S.E.M., n = 10, n = 5 (satellite group). * p < 0.05 compared with the control group.

Figure 5

The histological structure in H&E-stained images of different types of tissues from female rats in the study of chronic oral toxicity of Maha Pigut Triphala. (Scale bars, 100 μM; 10× magnification, 50 μM; 40× magnification).

Figure 6

The histological structure in H&E-stained images of different types of tissues from male rats in the study of chronic oral toxicity of Maha Pigut Triphala. (Scale bars, 100 μM; 10× magnification, 50 μM; 40× magnification).