Assessment of cytotoxicity, genotoxicity, and mutagenicity of the dexchlorpheniramine reference standard and pharmaceutical formula in human peripheral blood mononuclear cells

Abstract Dexchlorpheniramine is a first-generation classical antihistamine, clinically used to treat allergies. The main objective of our study was to evaluate the effects of the dexchlorpheniramine reference standard (DCPA Ref. St) and a pharmaceutical formula on DNA in human peripheral blood mononuclear cells (PBMCs). We exposed PBMCs to five different concentrations (0.5, 2.5, 5, 10, and 50 ng/mL) of DCPA Ref. St DCPA Ref. St and pharmaceutical formula in order to evaluate their cytotoxic, genotoxic, and mutagenic potential. The results showed that both dexchlorpheniramine formulations did not affect PBMC viability and CD3+, CD4+, or CD8+ lymphocyte subpopulations. The DCPA Ref. St and pharmaceutical formula neither induced genotoxic or mutagenic effects nor numerical or structural chromosomal alterations in PBMCs after 24 hours of exposure.

Tadalafil and Sildenafil illicit association: Stability- indicating HPLC method, photodegradation kinetic and toxicological studies

Abstract The illicit market of counterfeit medicines containing sildenafil and tadalafil has been causing serious public health problems. Thus, further studies on this illicit association are needed. A stability-indicating HPLC method was developed for simultaneous determination of tadalafil (TAD) and sildenafil (SIL) using a C18 column (250 x 4.6 mm, 5 µm). Detection was achieved at 284 nm, for TAD, and 292 nm, for SIL. The method was considered to be specific, linear, precise, accurate, robust, and sensitive. In the photodegradation kinetic studies, the drugs showed a first-order reaction rate when isolated, and zero-order when associated. Toxicological assays demonstrated that the photodegraded drugs decreased cell viability in compared to non- degraded drugs, suggesting cytotoxic activity. Additional, mutagenic activity was not observed under the tested conditions. Photodegraded drugs, in association, depicted DNA damage index, suggesting genotoxic effects. The obtained results will be able to support the forensic intelligence laboratories, as well as to alert the population about the risk inherent to consuming counterfeit products.

Steviol, the active principle of the stevia sweetener, causes a reduction of the cells of the immunological system even consumed in low concentrations.

AIM: Steviol is a natural diterpenoid glycoside isolated from Stevia rebaudiana Bertoni leaves and widely used as a non-caloric sweetener. In addition to their sweet taste, Steviol glycosides may also have some therapeutic benefits. There are few reports on the cytotoxicity of Steviol in human cells. Our objective was to test this sweetener under and at average concentrations of consumption, evaluating parameters of cytotoxicity, genotoxicity, and immunotoxicity. METHODS: For this purpose, we made use of lymphocyte cultures and the analysis of their CD3+, CD4+, and CD8+ subpopulations. In a complementary way, the mechanism of action is proposed here by computational methods. RESULTS AND CONCLUSION: Our results showed that Steviol reduces the number of lymphocytes due to falls of CD4+, CD8+, and CD4+CD8+ subpopulations. Besides, we observed an increase in the level of DNA damage and a gradual incidence of structural changes in the lymphocyte chromosomal sets. It was possible to propose that Steviol modulates gene expression, mainly interfering with the SESN1, NAP1L1, SOX4, and TREX1 genes. Although Steviol is used globally as a sweetener, its use should be cautious, as our study points out that Steviol has cytotoxic, genotoxic and mutagenic effects in the concentrations and conditions tested in the culture of human lymphocyte cells.

Validation of an analytical method by high-performance liquid chromatography and microbiological assay, biological safety and in silico toxicity for danofloxacin

Danofloxacin is a veterinary fluoroquinolone used to treat respiratory and gastrointestinal diseases of birds, pigs and cattle. The literature reviewed shows some analytical methods to quantify this fluoroquinolone, but microbiological and biological safety studies are limited. The analytical methods were validated by the Official Codes. The LC-DAD method was developed and validated using an RP-18 column, mobile phase containing a mixture of 0.3% triethylamine (pH 3.0) and acetonitrile (85:15, v/v). The microbiological assay was performed by agar diffusion method (3 x 3) and Staphylococcus epidermidis as a microorganism test. Forced degradation studies were performed in both methods. The minimum inhibitory concentration (MIC) was performed by test microdilution and toxicity studies were evaluated using in silico study, cell proliferation, cell viability test, micronuclei and comet assay. LC and a microbiological assay proved linear, accurate, precise, and robust to quantify danofloxacin, but only the LC method showed selectivity to quantify the drug in the presence of its degradation products. These results demonstrate that the LC method is suitable for stability studies of danofloxacin, but a microbiological assay cannot be used to quantify the drug due to the biological activity of the photoproducts. Ex-vivo cytotoxicity and theoretical and experimental genotoxicity were also observed.

Anabolic-androgenic steroids cycle administration decreases anxious-like behavior but does not affect long-term memory acquisition in rats

The steroid hormones are lipids in nature, which play crucial roles in several metabolic and behavioral pathways in mammals. Drug therapy uses sterol hormones for treating some disturbances linked with its deficiency; however, the illicit use of these hormones by amateur and elite athletes to enhance performance or body appearance may lead to several health issues. In this study we evaluated the anxious-like behavior and the long-term memory acquisition of male rats undergoing sedentary life-style or physical effort, with or without anabolic-androgenic steroids (ASC) treatment. The results showed a decrease in anxious-like behavioral levels in rats that received ASC treatment associated or not with physical effort, but this treatment did not affect the acquisition of long-term memory at the dose and experimental model assessed.

Essential oil of the leaves of Eugenia sulcata preserve myocardial contractility and does not present immunotoxicity

The essential oil of the leaves of Eugenia sulcata, in the Myrtaceae family, has a demonstrated antihypertensive effect, but its effects on heart muscle and its toxicity have not yet been elucidated. Little chemical or biological data are available for E. sulcata, whether emphasizing the beneficial effects or the pharmacological security of this species. This study aims to evaluate myocardial contractility and to analyze angiotensin converting enzyme (ACE) and myosin ATPase activities associated with use of this essential oil. In addition, we evaluated the immunotoxicity of E. sulcata essential oil. Wistar Kyoto (WKY) and spontaneously hypertensive rats (SHR) were treated daily for 30 days (10 mg/kg of oil) to evaluate the isometric force of the papillary muscle, ACE measured by fluorimetry, and myosin ATPase activities by inorganic phosphate. Lymphocyte cultures were used to evaluate cytotoxicity, DNA damage, and mutagenicity of the essential oil. The results demonstrate that the treatment did not change the cardiac contraction force and did not alter the functioning of the sarcoplasmic reticulum, extrusion of the membrane calcium, or modify the membrane calcium channels or ß-adrenergic receptor activity. Tetanic contractions were potentiated in the SHR animals. Myosin ATPase activity was also increased in the SHR animals. Cardiac ACE activity was reduced in both animal strains, and the serum ACE was reduced only in the SHR animals. The essential oil did not cause cytotoxicity or mutagenicity and presented low DNA damage. Our results demonstrated that the essential oil does not change myocardial contractility and does not present relevant immunotoxicity

Stability Study of Finasteride: Stability-Indicating LC Method, In Silico and LC-ESI-MS Analysis of Major Degradation Product, and an In Vitro Biological Safety Study.

Stability studies of the pharmaceutically important compound finasteride were conducted in order to evaluate decomposition of the drug under forced degradation conditions. A simple stability-indicating liquid chromatography method was developed and validated for the evaluation of finasteride and degradation products formed in pharmaceutical preparations and the raw material. Isocratic LC separation was achieved on a C18 column using a mobile phase of o-phosphoric acid (0.1% v/v), adjusted to pH 2.8 with triethylamine (10% v/v) and acetonitrile (52:48 v/v), with a flow rate of 1.0 mL min-1. The alkaline degradation kinetics of the drug were also evaluated and could be best described as second-order kinetics under the experimental conditions applied for the tablets and raw material. Based on in silico studies and molecular weight confirmation, a comprehensive degradation pathway for the drug and the identity of its major product could be suggested without complicated isolation or purification processes. Furthermore, a biological safety study was performed to evaluate the effect of the degraded sample in relation to the intact molecule. The results showed that the degraded sample affected the cell proliferation. Therefore, these studies show that special care must be taken during the manipulation, manufacture and storage of this pharmaceutical drug.

Evaluation of basil extract ( Ocimum basilicum L. ) on oxidative, anti-genotoxic and anti-inflammatory effects in human leukocytes cell cultures exposed to challenging agents

ABSTRACT Ocimum is one of the most important genera of the Lamiaceae family. Several studies about basil and its popular use reveal many characteristics of the herb, including its use as antioxidant, anti-aging, anti-inflammatory, anti-carcinogenic, anti-microbial, and cardiovascular agents, among others. In this paper, we evaluated genotoxic, oxidative, and anti-inflammatory parameters from the extract of Ocimum basilicum in different concentrations, using human leukocytes cultures exposed to challenging agents. Our results confirm that the O. basilicum extract acts as an antioxidant and effectively reverts or subjugates the effects of high oxidizing agents such as hydrogen peroxide. These actions are attributed to its composition, which is rich in polyphenols and flavonoids as well as compounds such as rosmarinic acid, all of which have well-known antioxidant activity. We also show that our basil extract presents anti-inflammatory properties, the mechanism of which is a composed interaction between the inhibition of pro-inflammatory mediator and the stimulation of anti-inflammatory cytokines. Although pharmacodynamics studies are necessary to evaluate the activities in vivo, our results demonstrated that basil could act as an antioxidant and anti-inflammatory and a possible alternative for medicinal treatment.

Cd, Cu, and Mn from Uruguay River Basin in Uruguaiana, RS, Brazil, and their toxicological potential for human leukocyte / Cd, Cu e Mn da Bacia do Rio Uruguai em Uruguaiana, RS, Brasil, e seu potencial toxicológico para leucócitos humanos

This study assessed the limnology from the Medium Uruguay River Basin in Uruguaiana, Brazil, with a focus on the concentration of heavy metals (Cd, Cu, and Mn), to assess the toxicological potential (cytotoxicity and genotoxicity) for humans using as biological matrix of study human leukocyte cells. The conductivity, resistivity, and dissolved O2 levels exceeded the limits recommended by the National Environmental Council (Conselho Nacional do Meio Ambiente - CONAMA). The percentage of non-viable human leukocyte cells exposed to water samples was approximately 20% higher than that of the negative control (<3%), but similar to the positive control. The DNA damage index was high for all heavy metal concentrations assayed when compared to the negative control 12±2.96, p < 0.0001, with a range of 155.66±23.89 to 194.33±23.23, but similar to the positive control (210.62±27.48). Moreover, the leukocyte degeneration index was higher in all samples containing heavy metals than in the negative control (4%), which demonstrates to be due the presence of Cu (11.8-12.5%), Cd (13-15.6%), and Mn (15.6-22.5%). Taken together, our results show that the quality from water samples analyzed is below than recommended by CONAMA and offers risk of contamination by heavy metals for the general population.

Este estudo avaliou a limnologia de amostras de água da bacia do rio Uruguai Médio, Brasil, focando as concentrações de metais pesados (Cd, Cu e Mn), para determinar o potencial toxicológico (citotoxicidade e genotoxicidade) utilizando como matriz biológica células leucocitárias humanas. A condutividade, resistividade e níveis de O2 dissolvido nas amostras analisadas excederam o limite recomendado pelo Conselho Nacional de Meio Ambiente (CONAMA). O percentual de células leucocitárias humanas não viáveis expostos às amostras de água foi de aproximadamente 20% maior que o controle negativo (<3%), mas similar ao controle positivo. O índice de dano ao DNA foi maior para todas as concentrações de metais testadas quando comparadas ao controle negativo (12±2,96), p < 0,0001, com uma variação de 155,66±23,89 a 194,33±23,23, mas estatisticamente semelhante ao observado para o controle positivo (210,62±27,48). Adicionalmente, o índice de degeneração leucocitário foi maior em todas as amostras contendo metais pesados que o controle negativo (4%), pela presença de Cu (11,8-12,5%), Cd (13-15,6%) e Mn (15,6-22,5%). Analisando esses dados conjuntamente, nossos resultados demonstram que a qualidade das amostras de água analisadas encontra-se abaixo da recomendada pela CONAMA e oferece risco de contaminação por metais pesados para a população em geral.

Evaluation of the tickcide, genotoxic, and mutagenic effects of the Ruta graveolens L (Rutaceae) / Avaliação dos efeitos carrapaticida, genotóxico e mutagênico da Ruta graveolens L (Rutaceae)

Current analysis investigated the tickcide effects of the aqueous extract and chloroform fractions of Ruta graveolens L. (rue) on engorged females of Rhipicephalus microplus, as well as their genotoxic and mutagenic effects on human leukocytes. The best tickcide activity (non-dependent dose) and genotoxic / mutagenic effects (dependent-dose) were observed on exposure to chloroform fractions. Results suggest that extract fractions of R. graveolens L are efficient against R. microplus, although the fraction and the tested concentrations show genotoxic and mutagenic potential for human leukocytes.

O efeito carrapaticida do extrato aquoso e frações da Ruta graveolens L. (arruda) sobre teleóginas de Rhipicephalus microplus, bem como seu potencial genotóxico sobre leucócitos humanos foram investigados neste trabalho. A melhor atividade carrapaticida (dose não dependente) e efeito genotóxico / mutagênico (dose dependente) foram observados nas frações clorofórmicas. Os resultados encontrados sugerem que frações clorofórmicas do extrato de Ruta graveolens L. são eficazes contra R. microplus, embora a fração e as concentrações testadas apresentem potencial genotóxico e mutagênico para células leucocitárias humanas.

In vitro ZnCl2 cytotoxicity and genotoxicity in human leukocytes: Zero-order kinetic cellular zinc influx / Citotoxicidade e genotoxicidade do ZnCl2 em leucócitos humanos in vitro: influx cellular de zinco com cinética de ordem zero

Zinc (Zn) is an essential trace element for cellular viability, but concentrations above physiologic level may lead to cellular damage. The purpose of the present study was to evaluate the in vitro ZnCl2 genotoxicity and cytotoxicity in human leukocyte cells. This was assessed in an unprecedented way that correlated the level of intracellular Zn after cell exposition with the cellular damage. The exposure to increased Zn concentrations (2.5-20 µg mL-1), showed significantly reduced cellular leukocyte viability. However, significant DNA damages were observed only when the Zn exposure concentrations were from 10-20 µg mL-1. The Zn intracellular levels found in leukocytes was from 72.25-268.9 ρ g cell-1, starting to induce cytotoxicity and genotoxicity at concentrations of 95.68 and 126.2 ρg cell-1, respectively. The relationship between the exposure concentration and intracellular levels of Zn suggests that the influx of Zn, in the form of ZnCl2, occurs in human leukocytes under zero-order kinetics.

O Zinco (Zn) é um elemento traço essencial para a viabilidade celular, mas em concentrações acima dos níveis fisiológicos pode conduzir a danos celulares. A proposta do presente estudo foi avaliar a citotoxicidade e genotoxicidade do ZnCl2 em leucócitos humanos in vitro. De maneira sem precedentes, foi acessado o nível de Zn intracelular após exposição e relacionado com o nível de dano celular. A exposição a crescentes concentrações de Zn (2,5-20 µg mL-1), mostraram significante redução da viabilidade celular dos leucócitos. Entretanto, danos significativos ao DNA foram encontrados somente a partir das concentrações de exposição ao Zn de 10-20 µg mL-1. Os níveis intracelulares de Zn encontrados nos leucócitos foram de 72,25-268,9 ρg célula-1, começando a induzir citotoxicidade e genotoxicidade nas concentrações de 95,68 and 126,2 ρg célula-1, respectivamente. A relação entre a concentração de exposição e os níveis intracelulares de Zn sugerem que o influxo de Zn, sob a forma de ZnCl2, ocorre em cinética de ordem zero em leucócitos humanos.

Antifungal activity against Cryptococcus neoformans strains and genotoxicity assessment in human leukocyte cells of Euphorbia tirucalli L.

In the last times, focus on plant research has increased all over the world. Euphorbia tirucalli L., a plant known popularly as Aveloz, and originally used in Africa, has been drawing attention for its use in the United States and Latin America, both for use as an ornamental plant and as a medicinal plant. E. tirucalli L. is a member of the family Euphorbiaceae and contains many diterpenoids and triterpenoids, in particular phorbol esters, apparently the main constituent of this plant, which are assumed to be responsible for their activities in vivo and in vitro. The in vitro antifungal activities of Euphorbia tirucalli (L.) against opportunistic yeasts were studied using microbroth dilution assay. The results showed that aqueous extract and latex preparation were effective against ten clinical strains of Cryptococcus neoformans in vitro (Latex and extract MIC range of 3.2 - > 411 µg/mL). Aiming the safe use in humans, the genotoxic effects of E. tirucalli were evaluated in human leukocytes cells. Our data show that both aqueous extract and latex preparation have no genotoxic effect in human leukocytes cells in vitro. Although the results cannot be extrapolated by itself for use in vivo, they suggest a good perspective for a therapeutic application in future. In conclusion, our results show that the aqueous extract and latex preparation from E. tirucalli L. are antifungal agents effectives against several strains of C. neoformans and do not provoke DNA damage in human leukocyte cells, considering the concentrations tested.

Contributing factors for farm workers' exposure to pesticides in the west of the state of Santa Catarina, Brazil / Fatores contribuintes para a exposição de trabalhadores rurais a pesticidas no Oeste de Santa Catarina, Brazil

Pesticide overuse is highly harmful to human health and has become a serious public health issue in developing countries, Brazil included. Current study collects and evaluates data on toxicity risk to farmers exposed to pesticides in Marema, a municipality in the west of the Brazilian southern state of Santa Catarina. The sectional, descriptive and observational study comprises a questionnaire with open and closed questions. Retrieved data showed that farmers with low educational level need understandable information to raise their awareness on the use of pesticides, starting from an effective assistance at purchase and in management till the disposal of empty containers. Data show that farmers undergo regular exposure risks to pesticides and traditional practices corroborate for the increase in the environmental damage and health problems.

Nos países em desenvolvimento como o Brasil, o uso excessivo de pesticidas tem resultado em prejuízos à saúde humana, o que reflete em sério problema de saúde pública. O objetivo deste estudo foi coletar e avaliar dados sobre o risco de toxicidade em agricultores expostos a agrotóxicos no município de Marema, localizado no Oeste de Santa Catarina, região Sul do Brasil. A pesquisa foi conduzida por um estudo descritivo, transversal e observacional por meio de questionário com perguntas abertas e fechadas, com o total de 100 amostras no município. Os dados obtidos demonstram que os agricultores, que possuem baixo nível de educação formal, necessitam de informações compreensíveis e conscientizadoras sobre o uso de agrotóxicos, incoando por uma efetiva assistência, desde sua aquisição e manejo até o destino final das embalagens vazias. Todos os dados nos levam a sugerir a presença de constante risco de intoxicação por agrotóxicos junto aos agricultores, uma vez que suas práticas corroboram para a instalação de danos ambientais e problemas de saúde.

Evaluation of toxicity risks in farmers exposed to pesticides in an agricultural community in Concórdia, Santa Catarina State, Brazil / Avaliação do risco de toxicidade em agricultores expostos a agrotóxicos em uma comunidade agrícola de Concórdia, Estado de Santa Catarina, Brasil

A utilização de agrotóxicos nas atividades rurais tem crescido ao longo dos anos com o intuito de aumentar a produtividade das lavouras e reduzir a mão-de-obra empregada. Em contrapartida, o uso excessivo ou sem medidas adequadas de biossegurança podem causar sérios danos à saúde humana. Este trabalho tem por objetivo avaliar o risco de toxicidade de 50 agricultores da comunidade da Linha São Paulo, município de Concórdia, Estado de Santa Catarina, expostos a produtos agrotóxicos pela aplicação de questionário com perguntas abertas e fechadas. Foi possível observar que estão presentes várias situações e procedimentos que expõem boa parte dos agricultores envolvidos nesta pesquisa a riscos de intoxicação, pois não possuem uma ideia clara a respeito das medidas de biossegurança, como também não há entendimento adequado sobre os produtos que utilizam, sugerindo carência na veiculação de informações acerca dos produtos. Estes dados corroboram para o aumento do risco à saúde dos agricultores entrevistados em sua rotina de trabalho. Dessa forma, fica fortemente destacada a necessidade de medidas voltadas à informação e sensibilização, que conscientizem e conduzam ao autocuidado no manejo de agrotóxicos.

There has been an increase during recent years in the use of pesticides in agricultural activities to improve productivity, reduce labor costs and increase profits. On the other hand, the use of pesticides in excess or without adequate biosafety practices could lead to serious harm to human health. Current research evaluated toxicity risks in the case of 50 agricultural workers from the São Paulo Rural Community in the municipality of Concordia, Santa Catarina State, Brazil, who were exposed to pesticides. The questionnaire with open- and closed-ended questions revealed that there are several situations and procedures that expose most farm workers to toxicity risks since they do not have a clear understanding of biosafety measures or suitable knowledge on the products they use. Since a lack of information on pesticides exists, there is strong evidence for measures to inform and raise consciousness so that agricultural workers may exercise self-care in handling pesticides.

In vivo and in vitro genotoxicity studies of aqueous extract of Xanthium spinosum

The use of plants as a source of palliative or cure for pathological conditions is quite common worldwide. Xanthium spinosum (Asteraceae), popularly known in Brazil as 'espinho de carneiro', is an annual weed from South America, which has been used by empiric medicine to treat neoplasias. Owing to the extensive use of the above-mentioned plant and to the lack of reports about the real effects of its infusion, current study evaluated the genotoxic potential of its aqueous extract at concentrations 0.02 g L-1, 0.1 g L-1 and 0.2 g L-1 by fish micronucleus test and by comet human leukocytes assay. The micronucleus test featured at least 50 cells with micronuclei to every 2,000 cells scored, as a mutagenic parameter. The comet assay was used as a parameter for assessing the level of cell damage and the damage index. Since no significant changes in strain cells exposed to the aqueous extract in the comet and micronucleus assays were reported, it seems that no genotoxicity evidence is extant at the concentrations and in the assays performed.

Em diversos lugares do mundo a utilização de plantas como fonte paliativa ou de cura para determinadas condições patológicas é bastante comum. No Brasil, essa prática não se torna diferente devido à ampla biodiversidade da fauna e flora presentes no País. Nesse contexto, surge a Xanthium spinosum (Asteraceae), conhecida popularmente como "espinho-de-carneiro", um arbusto anual introduzido na América do Sul, o qual tem sido utilizado empiricamente no tratamento de neoplasias. Sabendo do extensivo uso dessa planta em contrapartida com nenhum estudo reportando os reais efeitos de sua infusão, o objetivo do estudo foi avaliar a genotoxicidade do extrato aquoso nas concentrações de 0,02 g L-1, 0,1 g L-1 e 0,2 g L-1, através do ensaio do micronúcleo písceo e do ensaio cometa em leucócitos de sangue humano. O ensaio do micronúcleo tem como parâmetro mutagênico a presença de no mínimo 50 células com micronúcleo em uma contagem de 2.000 células por amostra, enquanto o ensaio cometa utiliza como parâmetro o nível de dano e o índice de dano. Os resultados mostram que não foi possível observar mudanças significativas nas células expostas ao extrato aquoso, em ambos os testes, o que sugere não existir evidência de genotoxicidade nas concentrações utilizadas no ensaio.

Avaliação in vivo do efeito hipocolesterolêmico e toxicológico preliminar do extrato bruto hidroalcoólico e decocção da Vitex megapotamica (Spreng) Moldenke (V. montevidensis Cham) / Evaluation of prospective hypocholesterolemic effect and preliminary toxicology of crude extract and decoction from Vitex megapotamica (Spreng) Moldenke (V. montevidensis Cham) in vivo

As doenças cardiovasculares (DC) estão, de modo geral, associadas a elevados níveis séricos de lipídeos, atingindo homens e mulheres, sem distinção de idade. Entre as propriedades atribuídas pela medicina popular à Vitex megapotamica (Spreng) Moldenke (V. montevidensis Cham) -Tarumã estão a de reduzir os níveis séricos de colesterol e triglicerídeo. O principal objetivo do presente estudo foi avaliar o potencial hipocolesterolêmico e hipolipidêmico da V. megapotamica, bem como fazer um estudo toxicológico preliminar. Para tanto, foi realizada indução hiperlipidêmica usando um modelo que preconiza o emprego de propiltiuracil 1,25 mg/300 g de peso e colesterol 200 mg/kg de peso, aplicados via oral em ratos machos pesando 300 ± 10 g. Foi administrado, por via oral, aos animais hiperlipidêmicos previamente induzidos 300 mg/kg de extrato hidroalcoólico das folhas de V. megapotamica ou 300 mL da decocção da casca da planta. Após o final de cada tratamento, o perfil lipídico foi ensaiado, bem como os níveis de glicose, quando relevante. Nossos resultados confirmaram o efeito hipolipidêmico do extrato hidroalcoólico e da decocção pela redução dos níveis séricos de colesterol e triacilglicerol nas concentrações, via e forma utilizadas. Além disso, foi possível verificar que não houve lesão cardíaca, hepática ou renal pelo extrato e decocção utilizados nas avaliações toxicológicas preliminares ensaiadas.

The cardiovascular diseases are, in general, associated with high levels of serum lipids which have high incidence in middle-age men and women. Among other properties characterized by popular medicine, the Vitex megapotamica (Spreng) Moldenke (V. montevidensis Cham) - Tarumã, decreases the serum cholesterol and triacylglycerol levels. The main proposition of the present study was to evaluate the hypocholesterolemic and hipolipidaemic potential of V. megapotamica and to analyze the preliminary toxicity. It was an induction hyperlipidaemic model using propiltiuracil 1.25 mg/kg weight and cholesterol 200 mg/ kg weight per oros in male rats, weigthing 300 ± 10 g. It was administred to the animals 300 mg/ kg of hydroalcoholic leaves extract of V. megapotamica or 300 mL of hull decoction per oros. After the end of each treatment, the lipid profile was essayed as well as glucose, when relevant. Our results confirmed the V. megapotamica extract and decoction hypolipidaemic effect by the decrease of cholesterol and triacylglycerides serum levels in concentration, via and preparation performed. Furthermore, the toxicological preliminary assays showed there was not extract and decoction damage induction in cardiac and hepatic tissues, as well as in kidney physiology by assays performed.