Abstract
The polyherbal formulation containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol ex. Maton has been used for hypertension treatment empirically. Our previous study showed its blood pressure-lowering effect on a rat model of hypertension. However, toxicity data were not available for this polyherbal formulation. This study is aimed at evaluating the acute and subchronic oral toxicity of the polyherbal formulation in rats. The acute toxicity study was conducted on 6 female Wistar rats using the fixed-dose method for the treatment group and 5 female Wistar rats for the control. The single dose of 2,000 mg/kg of the polyherbal formulation was given orally. There were no significant toxic effects and no death observed until the end of the study, and it was showed that the lethal dose 50% (LD50) of the polyherbal formulation was estimated to be more than 2,000 mg/kg. The macroscopic and microscopic examination of vital organs showed no symptoms of toxicity. At the subchronic toxicity study, the polyherbal formulation with 3 dose variations of 252 mg/kg, 1,008 mg/kg, and 4,032 mg/kg was administered for 91 days orally. The lowest dose of 252 mg/kg is equivalent to the daily recommended dose for a human. There were no significant toxic effects observed at all doses on physical sign and symptoms, weight gain, food intake, hematological parameters, biochemical parameters, and macroscopic and microscopic examination of organs. These findings showed that the short- and long-term oral administration of the polyherbal formulation is safe to use within its dose recommendation.
Highlights
Hypertension is a chronic disease that requires long-term medical treatment
There were no signs of toxicity in the preliminary study with a dose of 300 mg/kg on 1 rat, when the dose of 2,000 mg/kg was given to another 1 rat, and in the main testing of the same dose (2,000 mg/kg) in 4 rats
Not show any significant differences (p > 0:05) compared to the control group (Tables 12 and 13). These results indicated that administration of polyherbal formulation tablets at doses up to 4,032 mg/kg once daily for 91 consecutive days did not result in changes in absolute weight or relative weight of the heart, liver, lung, stomach, intestine, kidney, brain, spleen, testes, and ovaries
Summary
Hypertension is a chronic disease that requires long-term medical treatment. Antihypertensive works symptomatically to decrease blood pressure. The use of antihypertensive in the long term may cause various adverse side effects. Many researchers recommend a comprehensive approach in managing hypertension by diet regulation, exercise, and use of natural ingredients. Many medicinal plants grown in Indonesia have been traditionally used by communities to treat hypertension. Some plants have demonstrated antihypertensive activity on various hypertension animal models with various methods. These antihypertensive medicinal plants are Phyllanthus niruri [1], Catharanthus roseus
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