PREPARATION AND STANDARDIZATION OF EXPERIMENTAL BATCHES OF "PHOTORAN E6, LYOPHILIZATE FOR THE PREPARATION OF SOLUTION FOR INFUSIONS", A DRUG FOR PHOTODYNAMIC THERAPY USING HOGWEED LEAVES AS RAW MATERIALS

Abstract

Introduction. In recent years, there has been a sharp increase in the number of oncological diseases associated with more frequent detection of malignant neoplasms, including in the early stages. Photosensitizers are widely used for the diagnosis and treatment of oncological diseases. Already at the beginning of the twentieth century, it was discovered that a cancer cell is able to accumulate and retain colored substances [1]. In Russia, the photosensitizer "Photoran E6, lyophilizate for the preparation of an infusion solution" is widely used for the diagnosis of malignant tumors. The sub-stance for its production is sodium chloride E6, obtained by chemical synthesis from methylpheophorbide A. which, according to the patent, is extract-ed from the biomass of the green microalgae Spirulina Platensis, native to Japan and California. In this regard, there is an urgent question of replacing imported intermediates with more affordable ones. For this purpose, Sosnowski's hogweed (Heraculum sosnowskyi) was chosen. In connection with the above, the aim of this study was to obtain and standardize in terms of quality the finished drug for photodynamic therapy "Pho-toran E6, lyophilizate for the preparation of an infusion solution" produced from sodium chloride E6, synthesized using a new type of raw material (leaves of borscht Sosnowski). Material and methods. The object of the study was three series of the finished medicine product (hereinafter referred to as GLS) "Photoran, lyophi-lizate for the preparation of an infusion solution", produced from an active pharmaceutical substance synthesized from methylpheophorbide a, ob-tained, in turn, from the leaves of borscht Sosnovsky as an alternative source of vegetable raw materials [2]. The quality indicators of the finished me-dicinal product were determined according to the methods described in the regulatory documentation in accordance with the Regulatory Documentation of the XIV and XV editions. Results. For the research, the aseptic production of three series of GLS was carried out from the previously produced active pharmaceutical sub-stance Sodium Chloride E6. AFS was synthesized from an intermediate obtained from the leaves of borscht Sosnowski. The standardization of the ob-tained series of the drug has been carried out. The possibility of using Sosnowski's hogweed as a plant raw material for the production of photosensi-tizers based on chlorophyll derivatives has been evaluated. Conclusion. In the course of the study, the technology of aseptic production of GLS "Photoran, lyophilizate for the preparation of solution for infusions" was implemented. The quality indicators of the three produced batches of the finished drug have been determined.