Development of the technology of a lyophilized powder for preparing the solution for injections based on bee venom

Abstract

Cancer remains one of the most common causes of death among the population of most countries of the world. In this aspect, special attention is paid to new medicinal substances from bee products, including bee venom, which numerous components stimulate and strengthen the body as a whole, and at the same time its protective and restorative functions.Aim. To develop the technology of a lyophilized powder for preparing the solution for injections based on bee venom.Materials and methods. When creating and organizing industrial production of medicines based on bee venom the lyophilization was proposed as a technological method. It provides a long-term storage of drugs and is used to obtain stable freeze-dried powders, in particular for preparing solutions for injections (e.g. antibiotics, etc.) The main stage of the experimental research was development of the technology for obtaining a lyophilizate for injections. For this purpose, the conditions for freezing the solution based on bee venom were studied. The determination of the temperature and method of freezing the solution was carried out sequentially, the effect of the freezing duration on the quality of the final product and the process of sublimation drying of the drug were studied.Results and discussion. In order to determine the eutectic temperature having a specific value for each substance when freezing the solution based on bee venom we used the thermal method considered to be the most simple and advantageous. In the process of studying the effect of the freezing rate on the structure of the drug the solution based on bee venom was poured in 1 ml ampoules or in vials and frozen on the shelves of the sublimation unit to -50 °C; -60 °С, applying slow (stage-by-stage) and rapid freezing. The effect of the freezing method on the quality of a lyophilizate for injections from bee venom was assessed according to the following indicators: the appearance of the preparation, transparency, moisture, solubility, pH, the quantitative content of bee venom (in the cell), the quantitative content of lidocaine hydrochloride.Conclusions. The technology of a freeze-dried powder for preparing the solution for injections based on bee venom has been developed, namely: the optimal freeze-drying regime has been studied and determined. According to the results of the research the quality indicators of the drug have been determined.