DEVELOPMENT OF THE COMPOSITION AND TECHNOLOGY OF THE COMBINED INJECTION SOLUTION FOR MESOTHERAPY
DOI:
https://doi.org/10.11603/2312-0967.2022.4.13550Keywords:
combined drug, mesotherapy, ingredients, technology, hyaluronic acid, dihydroquercetin, L-arginineAbstract
The aim of the work. Development of the composition and technology of a combined injection drug for use in medicine and cosmetology based on sodium hyaluronate in combination with biologically active components - dihydroquercetin, L-arginine and auxiliary substances that ensure the stability of the dosage form.
Materials and Methods. The objects of the study were active substances: sodium hyaluronate, dihydroquercetin (INN Taxifolin), L-arginine, which met the requirements of the State Pharmacopoeia of Ukraine (SPhU) and/or the European Pharmacopoeia (EPh). Polyvinylpyrrolidone, succinic acid, sodium metabisulfite were used as auxiliary substances, co-solvents, complexing agents, antioxidants. Their quality also met the requirements of the SPhU and/or the EPh. Laboratory samples of solutions were packaged in ampoules of 2 ml. Physico-chemical, pharmaco-technological, and microbiological methods were used in accordance with the requirements of the State Pharmacopoeia of Ukraine and the EPh. The pH of the solutions was controlled by the potentiometric method. Quantitative determination of active substances was carried out by the HPLC method.
Results and Discussion.The composition and technology of the combined injection drug have been developed. Based on the physico-chemical properties of the starting ingredients, the choice of auxiliary substances for a stable solution is substantiated. The initial amounts of succinic acid, sodium hydroxide, and L-arginine were calculated according to the stoichiometry of the salt formation reaction, and the optimal conditions for the reaction at the stage of solution preparation were established. The technological parameters of the preparation of the combined solution were studied. The research on the filter material selection and the mode of the solution sterilization was carried out.
Conclusions. The composition and manufacturing technology of the combined injection drug are substantiated. The technological parameters of the preparation of the solution were defined (order of loading the components, temperature and time regimes, speed of mixing). A technological block diagram for the production of the combined drug has been developed.
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