Abstract

Research objective: to standardize a new herbal product "Flucam" for its introduction into a medical practice.
Materials and methods. The study included the samples of the "Flucam" herbal product, consisting of specific species of plant raw materials, approved for medical use and provided with a sufficient raw material base on the territory of Uzbekistan. The development of standardization methods was carried out on five series of "Flucam" in accordance with the instructions of the SP XI edition, as well as the recommendations of the WHO, the International Conference on the Harmonization of Technical Requirements for Medicines Registration (ICH) and the requirements of the technical regulation on the safety of medicines.
Results and discussion. As a result of the research, the principles of standardization of the new herbal product "Flucam", recommended as the effective immunomodulatory drug, were proposed and substantiated. The characteristics of identification and indicators of the species purity were determined. Besides, we developed and introduced procedural methods for the qualitative and quantitative determination of the main active substances - the tannins and glycyrrhizic acid.
Conclusion. During the research, characteristics of identification and quality indicators of the product, as well as the optimal terms of its storage were experimentally determined and substantiated. Based on the study of microbiological purity and the content of hazardous contaminants - toxic heavy metals, radionuclides and pesticides, the possibility of safe use of "Flucam" was established.