This project aimed at developing a gastro-resistant coated tablet using traditional herbal medicine dry extract from the secondary roots of the plant species Harpagophytum procumbens DC. (Pedaliaceae), standardized in harpagoside 20%, popularly known as "devil's claw". The tablets were produced by direct compression and coated with the gastro-resistant dispersion. Accelerated and long-term stability studies were performed to define the period of use and validity. The tablets present a high dose of chemical markers differently from the usual pharmaceutical forms, diminishing the daily doses to 1 or 2 tablets. The hardness, friability, weigh and thickness were in agreement with the Brazilian Pharmacopeia 5 th Edition. The analytical method used was validated to confirm the assays. The gastroresistant coated tablets, obtained from the dried extract of H. procumbens DC., standardized in harpagoside 20%, was stable after the accelerated study and the analytical methodology was validated.Key words: Pedaliaceae, Harpagophytum procumbens DC., devil's claw, traditional herbal medicine, gastroresistant coated tablets. INTRODUCTIONHarpagophytum procumbens DC. belongs to the family Pedaliaceae. This perennial herbaceous plant, popularly known as "devil's claw", grows naturally in the Kalahari desert and in the steppe region of Namibia in southwestern Africa. Its secondary tubular roots, commonly associated with the term "devil's claw" by its shape, have been widely used in traditional medicine with several therapeutic indications, especially as antiinflammatory and analgesic (Baghdikian et al., 1997 exclusive use of vegetal active raw materials whose safety and effectiveness are based on data of safe and effective use published in the technical-scientific literature, and which are designed to be used without supervision by a physician for diagnostic, prescription or monitoring purposes". Thus, in Brazil, the dry extract produced from the roots of the H. procumbens DC. plant species, standardized on harpagoside, is classified as a traditional herbal product, and indicated for the relief of moderate joint pain and acute low back pain, according to the ethnopharmacological use described in the literature. In addition, advances in the scientific area have allowed the development of proven medicines and herbal products of safety and efficacy, as well as an increase in the population's search for less aggressive therapies for primary health care (Ribeiro et al., 2005). Given the importance of herbal medicines worldwide, the study of plant species such as H. procumbens DC. has been considered to be of extreme relevance for the development of new therapeutic alternatives with efficacy and low adverse effects compared to synthetic drugs. H. procumbens DC. extract has been constantly investigated as a potential therapeutic agent because of its analgesic and anti-inflammatory activities, and favorable adverse effects profile compared to available synthetic alternatives such as non-steroidal antiinflammatory drugs (Ahmed et al., 2005)....
Background: It has already been shown that melatonin is an antitumoral molecule that affects malignant cells via some mechanisms. The benefit played by this hormone on cancer is due to its antioxidant effects. Objective: This study aimed to evaluate the preclinical effects of melatonin in mice with the Ehrlich ascites tumor. Methods: Twenty Balb/ c male mice with Ehrlich tumor were treated with different melatonin doses. Their inflammatory and oxidative stress were accessed by gene expression. Hepatotoxicity and hematological parameters were also evaluated through biochemical analyses. Animal welfare was analysed weekly from the categories guided by the NC3Rs. Results: Gene expression analyses have shown that only Tnfα and Sod1 were expressed in all groups studied. Only the M-3 group showed increased Tnfα expression compared to the control. All groups treated with melatonin showed decreased Sod1 expression compared to the control. No signs of hepatotoxicity were caused by any of the melatonin doses used in the treatment. Conclusion: In animals with Ehrlich´s tumor treated with melatonin, a decrease in oxidative stress, an amelioration in welfare and in cognitive tasks could be observed, even if the treatment has not reduced the size of the tumor itself. In parallel with the already patented use of melatonin in the treatment of sleep disorders or chronic kidney disease, our results propose its use to improve the general well-being of breast cancer patients.
It has already been shown that the melatonin is an antitumoral molecule that affects malignant cells via some mechanisms. The benefits played by this hormone on cancer apparently is due to its antioxidant effects. This study aimed to evaluate the preclinical effects of melatonin on the Ehrlich ascites tumor. Twenty Balb/ c male mice with Ehrlich tumor were treated with different melatonin doses. Their inflammatory and oxidative stress were accessed by gene expression. Hepatotoxicity and hematological parameters were also evaluated through biochemical analyzes. Animal welfare was analyzed weekly from the categories guided by the NC3Rs. All groups treated with melatonin showed decreased SOD expression compared to the control; TNF-α expression, however, was higher in M-3 group. In the hepatic and hematological analyzes, the use of melatonin did not present significant changes in its results, that is, no hepatotoxicity could be identified. Melatonin played an important role in maintaining the parameters evaluated when referring to the well-being of the treated groups when compared to the control group. In the cognitive evaluation, the group that was treated with melatonin at the dosage of 3mg, presented better performance when compared to the others.
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