Study of stability of anti-scarring ointment with water-soluble proteinpolysaccharidic complex of the fungus Pleurotus ostreatus during the storage

Abstract

The problem of the treatment of scar tissue of the skin is quite relevant.The most affordable, convenient and comfortable way to treat scar formation is the use of soft dosage forms.So developing an effective ointment with anti-scarred activity is an urgent task of pharmaceutical technology. One of the important tasks in the process of creating original medicines is obtaining stable storing and using pharmaceutical products. For establish the shelf life it was necessary to determine the time during which the created medicine will be able to maintain stability and meet all the requirements stated in the regulatory documentation. The aimisthe study of stability of experimental samples of ointment composition with anti-scarred activity with water-soluble protein-polysaccharide complex of Pleurotus ostreatus mushroom and determination of the optimal shelf life of the created ointment. The object of the study was an original ointment composition based on an emulsion, the active component of which was a water-soluble protein-polysaccharide complex of Pleurotus ostreatus mushroom. Ointment samples were placed in polymer containers, which were hermetically sealed and stored in a dark place at room temperature (+15–25 °C) and in a refrigerator (+2–8 °C). Studies of the stability of the soft dosage form were performed on organoleptic and physicochemical parameters (description, homogeneity, pH, identification, colloidal and thermal stability, quantification and signs of microbial contamination). Measurements were performed on five lots of ointment samples after preparation and every 6 months for 3 years. The results of the study of the quality of anti-scarring ointment with water-soluble protein-polysaccharide complex of Pleurotus ostreatus mushroom indicate a rational choice of auxiliary substances and their concentration, the choice of the optimal technological process and the lack of interaction between the components of the medicine. On the basis of the conducted researches it is proved that anti-scarring ointment with water-soluble protein-polysaccharide complex of Pleurotus ostreatus mushroom remains stable for 2 years at the temperature from +2 to + 25 °С.Thus, it was found that the study samples of ointments during this period have satisfactory technological parameters.