| 摘要 |
Production procedure for obtaining a gel type preparation with liposomes wherein incapsulated is clindamicine phosphate, for eradication of young acknae, the preparation will be locally applied, it is characterized in that it comprises two stages: preparation of liposome dispersion with clindamicine and incorporation of liposome dispersion in gel layer. Preparation of liposome dispersion is carried so that the lipide phase, that comprises 20% mixture of saturated phospolipides disperged into the mixture of hydrophilic solvents - etanol, glicerole and water (5,00 - 40, 00 mass %), vitamin E-acetate (0,500 -20,00 mass %), buthilhidroxytoluole (0,050 - 0,500 mass % ) and mixture of phenoxyethanole-methyl-ethyl-propyl-buthil-parabene (0,050 -1,00) is warmed at the temperature in the range from 55-65°C and hydrates by adding part of water phase, along with mixture, that is made of a solution of clindamicine in the form of clindamicine-phosphate (4,00 - 10,00 mass %) in purified water (5,00 - 40,00 mass %), pH value in the range from 6,0-7,0, that is warmed at the temperature 52 °C , and dilutes by purified water (15,00 - 85,00 %) warmed at the temperature 52-55 °C and homogenizes at the temperature from 35 - 40 °C by passing through a high pressure homogenizer under 75-325 bar and 2-5 cycles. Obtained dispersion of liposomes is incorporated in the base prepared by mixing the water stage (10,00 - 95,00 mass %), warmed in the temerature range from 40 - 85 °C, wherein are dissolved hidrophilic components: propylenglicol (1,00 -5,00 mass %), imidazolidinylurea (0,05 - 0,20 mass %) with oily phase warmed at the temperature from 45-85° °C composed from lipophilc hydrophile compounds: (0,05 -40,00 mass %). Natriumacrylatenatriumacryloildimetyltaurates, isohexadekanes and polysorbates 80 (2,00 - 20,00 mass %), C12-C15 alkyl benzoates, (0,01 - 0,10 mass %) butihydroxytoluole, (0,02 - 0,30 mass %) phenoxyethanole-methyl-ethyl-ethyl-propyl-parabene. Adding on liposome dispersion with clindamicine phosphate (10-25 mass %) is carried out at the temperature in the range from 35-40 °C, along with mixing within 5-40 minutes, at the speed of 35 rev/min, thus the density of clindamicine in the ready-made product is 1 %, where a gel of homogenous appearance is obtained and the pH value of it varies in range from 5,0 to 7,0. |
