Toxicity Studies of Bougainvillea glabra and Mucuna pruriens Methanol Extracts on Wistar Albino Rats for Pharmaceutical Applications

Abstract

ABSTRACT The invention relates to toxicity studies of methanol extracts of Bougainvillea glabra and Mucuna pruriens on Wistar albino rats. The study includes both acute and subchronic toxicity assessments. The acute toxicity was evaluated by administering 2000 mg/kg body weight and monitoring the subjects for 14 days, while the subchronic toxicity was studied over a period of 90 days with doses of 250, 500, and 1000 mg/kg. The results indicate that the methanol extracts are non-toxic at the tested doses, with no significant alterations observed in body and organ weights, hematological parameters, or serum biochemical markers. This invention demonstrates the potential of Bougainvillea glabra and Mucuna pruriens extracts as safe for further pharmaceutical development.

Specification

Description:FIELD OF THE INVENTION

The present invention pertains to the field of pharmaceutical chemistry and toxicology, specifically focusing on the safety evaluation of plant-derived compounds for therapeutic applications. The invention is aimed at ensuring the safety of methanol extracts of Bougainvillea glabra and Mucuna pruriens in preclinical models.

BACKGROUND OF THE INVENTION

Herbal medicines have been traditionally used to treat a variety of ailments. Despite their widespread usage, safety evaluations are essential for the development of pharmaceutical applications. Bougainvillea glabra and Mucuna pruriens are two medicinal plants known for their therapeutic potential. However, there is limited data on their toxicity profiles. This invention addresses the need for comprehensive toxicity evaluations of these plants, focusing on their methanol extracts.

Toxicity associated with herbal preparations has raised concerns, necessitating stringent evaluation protocols. Acute and subchronic toxicity assessments are critical in determining the safety and potential pharmaceutical use of herbal products.


OBJECTIVES OF THE INVENTION

1. To Evaluate the Acute Toxicity
The primary objective of the invention is to evaluate the acute toxicity of methanol extracts of Bougainvillea glabra andMucuna pruriens in Wistar albino rats. The goal is to determine the safety levels of these extracts by administering a high dose (2000 mg/kg) and observing any potential toxicity or adverse effects over a 14-day period.

2. To Assess the Subchronic Toxicity
Another key objective is to assess the subchronic toxicity of these plant extracts by administering varying doses (250, 500, and 1000 mg/kg) over a prolonged period of 90 days. The study focuses on evaluating the long-term effects on body weight, organ weight, and overall physiological responses in the test animals.

3. To Analyze Hematological and Biochemical Parameters
The invention aims to analyze the effects of Bougainvillea glabra and Mucuna pruriens extracts on hematological parameters (e.g., RBC, WBC, hemoglobin) and biochemical markers (e.g., SGOT, SGPT, creatinine, urea). These analyses will help to determine if there are any significant changes or toxicological impacts on the blood profile and metabolic functions of the animals.

4. To Study the Effects on Organ Health
A critical objective is to monitor the potential effects of the methanol extracts on the weight and histopathology of key organs, such as the liver, kidneys, heart, lungs, and spleen. The objective is to identify any organ damage or changes in relative organ weight as a result of long-term exposure to the extracts.

5. To Establish the Non-Toxicity of the Plant Extracts
The invention aims to provide conclusive evidence that the methanol extracts of Bougainvillea glabra and Mucuna pruriens are non-toxic at the tested doses. The study intends to validate the safety of these extracts for potential use in pharmaceutical applications.

6. To Provide a Safety Profile for Future Pharmaceutical Use
The ultimate objective is to generate a comprehensive safety profile for the methanol extracts of these plants, which can serve as a foundation for their future inclusion in herbal medicines or pharmaceutical formulations. The results of this study are intended to encourage further research and development of plant-based therapeutics.

7. To Support the Development of Plant-Based Therapeutics
The invention seeks to contribute to the growing field of plant-based therapeutics by establishing the safety of Bougainvillea glabra and Mucuna pruriens extracts. This will promote their use in the development of safe, effective, and natural treatments for various ailments.

SUMMARY OF THE INVENTION

The present invention relates to a comprehensive study of the toxicity of methanol extracts from two medicinal plants, Bougainvillea glabra and Mucuna pruriens, conducted on Wistar albino rats. The study is aimed at evaluating the safety of these plant extracts, with a focus on their potential application in the development of pharmaceutical products.

In this invention, both acute and subchronic toxicity studies were performed to assess the safety profile of the extracts. For the acute toxicity study, a single dose of 2000 mg/kg body weight of methanol extracts was administered orally to the test animals, and they were observed for a period of 14 days. No significant signs of toxicity, mortality, or behavioral abnormalities were noted, indicating that the extracts are safe at this high dose level.

The subchronic toxicity study involved daily oral administration of the methanol extracts at three different doses (250 mg/kg, 500 mg/kg, and 1000 mg/kg) for a period of 90 days. Throughout the study, various parameters were monitored, including body weight, organ weight, hematological markers (such as red blood cells, white blood cells, and hemoglobin), and serum biochemical parameters (such as SGOT, SGPT, creatinine, and urea).

The results of the subchronic toxicity study revealed no significant changes in body weight or organ weight, and the hematological and biochemical markers remained within normal ranges. This indicates that both Bougainvillea glabra and Mucuna pruriens extracts were well tolerated at all tested doses. Furthermore, the histopathological examination of vital organs such as the liver, kidneys, lungs, and heart showed no adverse effects or tissue damage, further confirming the non-toxic nature of the extracts.

This invention concludes that the methanol extracts of Bougainvillea glabra and Mucuna pruriensexhibit no significant toxicological effects in both acute and subchronic studies. The extracts were found to be non-toxic up to the tested dose of 2000 mg/kg, making them safe for further research and development in pharmaceutical applications.

The non-toxicity of these extracts provides a strong basis for their potential use in developing plant-based therapeutic agents. This study contributes to the growing body of research on herbal medicines, supporting the development of safe, effective, and natural treatments for various diseases. The findings of this invention can be used as a reference for regulatory and safety evaluations of Bougainvillea glabra and Mucuna pruriens extracts in the pharmaceutical industry.

BRIEF DESCRIPTION OF THE DIAGRAM
The diagram presents photomicrographs of liver sections from Wistar albino rats treated with methanol extracts of Bougainvillea glabra at varying doses (250 mg/kg, 500 mg/kg, and 1000 mg/kg) for 90 days. The images also include a control group for comparison.
● Control Group: The liver sections display normal hepatic architecture, with well-organized cellular structures, clear sinusoids, and intact hepatocytes. No signs of necrosis or tissue damage are observed, indicating healthy liver function.
● 250 mg/kg Treatment: The liver section at this dose shows a similar healthy architecture to the control group. The hepatocytes and liver sinusoids are intact, with no significant alterations in cellular structure.
● 500 mg/kg Treatment: At this dose, the liver section maintains its normal structure, with clear hepatocytes and well-defined sinusoids. There are no signs of cellular degeneration, necrosis, or damage, suggesting the absence of toxic effects.
● 1000 mg/kg Treatment: Even at the highest dose, the liver section continues to show normal cellular architecture, with no evidence of necrosis or pathological changes. The hepatocytes remain healthy and well-organized.

DESCRIPTION OF THE INVENTION

1.Plant Material Collection and Extraction The entire plants of Bougainvillea glabra and Mucuna pruriens were collected from a botanical garden and authenticated by taxonomists. Methanol extracts were obtained using Soxhlet extraction. The solvent was evaporated, and the concentrated extracts were stored in a desiccator for further use.
2. Experimental Animals
Wistar albino rats weighing 200-250 grams were procured and housed in a controlled environment with a 12-hour light/dark cycle. The animals had free access to water and a standard diet. All experiments were conducted in compliance with guidelines set by the Institutional Animal Ethical Committee.
3. Acute Toxicity Study
A single oral dose of 2000 mg/kg of methanol extracts of Bougainvillea glabra and Mucuna pruriens was administered to different groups of rats. The animals were observed for 14 days for any signs of toxicity, including changes in locomotion, respiration, or piloerection. No deaths or significant symptoms were recorded, indicating that the extracts are safe at this dosage.
4. Subchronic Toxicity Study
The subchronic toxicity study involved the oral administration of methanol extracts at doses of 250 mg/kg, 500 mg/kg, and 1000 mg/kg for 90 days. The study evaluated several parameters:
● Body and Organ Weight: Body weight was recorded weekly. At the end of the experiment, organs such as the liver, kidneys, heart, lungs, and spleen were weighed, and relative organ weights were calculated. No significant differences were observed between the treated and control groups.
● Hematological Parameters: Blood samples were collected to assess red blood cell count (RBC), white blood cell count (WBC), hemoglobin (Hb), and other markers like mean corpuscular hemoglobin (MCH) and mean corpuscular volume (MCV). The extracts did not cause any notable alterations in these parameters.
● Biochemical Parameters: Serum samples were analyzed for markers of liver and kidney function, including serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), alkaline phosphatase (ALP), creatinine, urea, and bilirubin. The results showed no toxicologically significant changes in the biochemical markers.
● Histopathology: Tissues from the liver, kidneys, heart, lungs, and spleen were examined microscopically for any signs of cellular damage, necrosis, or inflammation. The histological examination revealed no abnormalities, further confirming the non-toxic nature of the extracts.
Advantages of the Invention
1. Non-Toxicity: Both Bougainvillea glabra and Mucuna pruriens methanol extracts were shown to be safe and non-toxic in both acute and subchronic toxicity studies, making them suitable candidates for further pharmaceutical development.
2. Pharmaceutical Potential: The study provides a foundation for the development of herbal medicines derived from Bougainvillea glabra and Mucuna pruriens, contributing to the growing interest in plant-based therapeutics.
3. Comprehensive Analysis: The invention offers a detailed analysis of the toxicity profile, covering acute and subchronic phases, as well as both hematological and biochemical parameters, ensuring a thorough safety assessment.


 
, Claims:WE CLAIMS

1. A method for evaluating the acute toxicity of methanol extracts of Bougainvillea glabra and Mucuna pruriens, wherein an oral dose of 2000 mg/kg body weight is administered to Wistar albino rats, and the subjects are observed for a period of 14 days, showing no mortality or signs of toxicity.

2. A method for evaluating the subchronic toxicity of methanol extracts of Bougainvillea glabra and Mucuna pruriens, comprising the daily administration of doses at 250 mg/kg, 500 mg/kg, and 1000 mg/kg body weight for 90 days to Wistar albino rats, wherein the method shows no significant adverse effects on body weight, organ weight, hematological parameters, or serum biochemical markers.

3. The use of methanol extracts of Bougainvillea glabra and Mucuna pruriens as non-toxic agents for pharmaceutical applications, where toxicity assessments, including body weight monitoring and organ weight analysis, show no significant variations between treated and control animals.

4. A method for analyzing the hematological effects of Bougainvillea glabra and Mucuna pruriens extracts, wherein the red blood cell count (RBC), white blood cell count (WBC), hemoglobin (Hb), mean corpuscular hemoglobin (MCH), and mean corpuscular volume (MCV) remain unaffected by the daily oral administration of the extracts at up to 1000 mg/kg body weight over 90 days.

5. A method for evaluating the biochemical effects of Bougainvillea glabra and Mucuna pruriens methanol extracts, wherein serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), creatinine, urea, and bilirubin levels are measured after 90 days of treatment, and the results show no significant deviation from control levels, indicating no liver or kidney toxicity.

6. The use of methanol extracts of Bougainvillea glabra and Mucuna pruriens in developing safe plant-based pharmaceuticals, wherein the histopathological examination of liver, kidney, heart, lung, and spleen tissues shows no signs of necrosis, inflammation, or structural damage after oral administration of the extracts for 90 days.

7. A method for determining the relative organ weight in rats treated with methanol of Bougainvillea glabra and Mucuna pruriens, wherein the liver, kidneys, heart, lungs, and spleen show no significant differences in weight compared to control groups after 90 days of daily oral administration of the extracts.

8. A pharmaceutical composition comprising methanol extracts of Bougainvillea glabra and Mucuna pruriens, wherein the composition is determined to be non-toxic based on acute and sub chronic toxicity studies in Wistar albino rats.

9. A method for enhancing safety validation in plant-based medicines using toxicity evaluation of methanol extracts of Bougainvillea glabra and Mucuna pruriens, wherein the plant extracts do not induce any significant adverse changes in physiological or biochemical parameters in a 90-day sub chronic study and also method for assessing organ protection properties of Bougainvillea glabra and Mucuna pruriens methanol extracts, wherein daily oral doses of the extracts for 90 days enhance the immune system and do not produce any signs of chronic toxicity in vital organs such as the liver and kidneys.

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