Elaboración y Control de Calidad de Comprimidos Fitofarmacéuticos de Ajenjo (Arthemisia absinthium L.), Romero (Rosmarinus officinalis L.) y Manzanilla (Matricaria chamomilla L.) para Combatir la Menstruación Dolorosa.

Abstract

In the laboratories of the Faculty of Sciences of the Escuela Superior Politécnica de Chimborazo and in the Pharmaceutical Pilot Plant of the Universidad Central del Ecuador, we developed the elaboration and quality control of phytopharmaceutical tablets based on wormwood, rosemary and chamomile, which due to their powerful emmenagogue, anti-inflammatory and analgesic properties, respectively, help to combat painful menstruation. For this purpose, quality control was performed on raw materials, manufacturing process and finished product, obtaining values that are within the specifications established in the methodologies of WHO, AOAC, Ecuadorian Standard of Raw Drug Phytotherapeutic INEN, USP XXIII, USP XVIII and Rémington's Practical Pharmacy. The unitary formula for the phytopharmaceutical tablets is constituted by vegetal drug as active ingredient in 43%, binder P.V.P 2%, diluents: corn starch in 28% and lactose in 25%; lubricants: talc in 0.4% and magnesium stearate 0. 6%; avicel, which acts as a disintegrator in 1%, obtaining tablets of 700 mg in weight with 301 mg of active principle based on wet granulation, allowing them to comply with all the established quality parameters such as organoleptic characteristics, humidity of 3.216%, hardness 8.46 Kp, average weight 713 mg, disintegration in 1.51 minutes and friability of 0.85%. The therapeutic activity of the tablets was proven with an in vivo study in the Compania Labranza Community located in the Colta Canton with a group of ten women who were administered a 700 mg dose of one tablet every 8 hours for 5 days before the menstrual cycle, proving the therapeutic efficacy of the tablets with a second administration, eliminating menstrual cramps by 100%.