DEVELOPMENT OF TECHNOLOGY FOR COLLECTING AND DRYING HERBAL MATERIALS OF HEDYSARUM SEMENOWII REGEL & HERDER IN THE “QUALITY BY DESIGN” CONCEPT

The development of optimal technology for collecting and drying raw materials of Semenov's sweetvetch (Hedysarum semenowii Regel & Herder) ensures the preservation of pharmacological properties, quality consistency, increased efficiency, and environmental sustainability. This process requires consideration of the influence of a large number of different factors and their assessment. The inclusion of the concept “Quality by Design” (QbD) in the development process, which focuses on obtaining finished products with multi-factor quality risks, can facilitate and enable improvements. The application of QbD provides a systematic, risk-reducing, efficient structure that helps support continuous process improvement. The aim is the development of technology for collecting and drying Hedysarum semenowii Regel & Herder medicinal plant materials of pharmacopoeial quality using the “Quality by Design” concept. Materials and methods. The research materials were plant parts from Semenov's sweetvetch: aerial parts collected during the flowering period and roots collected at the end of fruiting. All collected plant specimens were identified by employees of the RSE REM “Institute of Botany and Phytointroduction”. According to QbD principles, to create a Design Space (DSp) of the process of obtaining herbal materials of Semenov's sweetvetch, Minitab statistical software was used. Results and discussion. Introduction of QbD principles in the development of a method for the procurement of H. semenowii herbalmaterials – H. semenowii aerial parts and H. semenowii roots – made it possible to develop the most optimal drying method. By adhering to best practices of the Good agricultural and collection practices for medicinal plants (GACP) and using Minitab statistical software, the relationship between quality and critical process parameters such as temperature and drying time was determined. This approach facilitated the determination of DSp, ensuring controlled and high-quality implementation of the technological process. Conclusion. Integration of the QbD concept into the development of technology for collecting and drying Semenov’s sweetvetch herbal materials has proven its effectiveness. The defined DSp, generated taking into account optimal process parameters, lays the foundation for a controlled and reproducible production process. This study demonstrates the potential of QbD to improve quality, efficiency, and control in herbal medicine development.