FIELD: biological engineering for lyophilic drying of biological preparations. SUBSTANCE: method provides for lyophilization of materials at low temperature (minus 30 C and lower) at higher temperatures of the process. Method includes introduction of protective medium in solution of biological preparation before drying is started followed by freezing the mixture thus obtained and vacuum drying. Introduced additionally in protective medium is filler which is crystallized during freezing diluted water solution; filler is introduced in concentration adequate for forming the amorphous crystal structure in volume of liquid phase of biological preparation remaining after crystallization of water. Before drying, test specimens of biological preparation are prepared together with protective medium or protective medium only at different concentration of filler; then thermal or X-ray phase analysis is conducted or trial lyophilization is performed at drying temperature which is equal to or higher than collapse temperature of initial biological preparation; concentration of filter is selected to be equal to or exceeding concentration of filter in test specimen of biological preparation; curve of thermal or X-ray phase analysis includes additional peak as compared with similar curve of thermal or X-ray analysis of specimen of initial biological preparation of equal or higher concentration of filler in test specimen of biological preparation illustrating present of table after lyophilization. Sodium or potassium chloride or glycine is used as filler. EFFECT: enhanced efficiency. 5 cl, 3 tbl
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Authors
Dates
1998-05-20—Published
1995-11-03—Filed