Examinando por Autor "Borja Bartolo, Kely"

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    Efecto gastroprotector del extracto hidroalcohólico de las hojas de Mutisia acuminata R. & P. "Chinchilcuma"
    (Universidad Privada Norbert Wiener, 2013) Borja Bartolo, Kely; Chávez Flores, Juana Elvira
    The increase in the commercialization of adulterated medicines and the lack of control in the Peruvian pharmaceutical market pose risks to patients’ health. The objective of the present work is to contribute to the control and sanitary surveillance of amoxicillin in film-coated tablets. Amoxicillin was chosen as the sample because it is an essential medicine, and three aspects were evaluated: first, the origin of the medicine, using checklists based on Supreme Decrees No. 014-2011/SA and 016-2011/SA. Second, the physicochemical evaluation of medicines of dubious and reliable origin was carried out, taking as reference the monograph of Amoxicillin Tablets, the general chapters <905> and <1151> of the United States Pharmacopeia 35. Third, the behavior of amoxicillin after being subjected to accelerated partial-time stability conditions was evaluated according to Sanitary Directive No. 031-MINSA/DIGEMID, which regulates stability studies of medicines. The reliable-origin sample complied with the requirements of Supreme Decrees No. 014-2011/SA and 016-2011/SA. The dubious-origin samples (DOS) 2 and 3 complied with the requirements of Supreme Decree No. 016-2011/SA, whereas DOS1 did not; the establishments from which the dubious-origin samples were taken did not comply with the requirements of Supreme Decree No. 014-2011/SA. In the physicochemical analysis, the samples met the acceptance criteria of USP 35 and of Sanitary Directive No. 031-MINSA/DIGEMID. It is concluded that amoxicillin marketed in non-pharmaceutical and pharmaceutical establishments meets the physicochemical acceptance criteria and is stable under accelerated partial-time stability conditions; however, the non-pharmaceutical establishments did not comply with the requirements of Supreme Decrees No. 014-2011/SA and No. 016-2011/SA.