AGENT NORMALIZING KIDNEY FUNCTION AND METHOD FOR ITS PREPARING Russian patent published in 2007 - IPC A61K35/23 A61P13/12 

FIELD: medicinal industry.

SUBSTANCE: invention relates to a method for isolating biologically active substance from mammalian kidney and preparing a medicinal formulation for parenteral administration that can be used in medicine as agent normalizing kidney functions. Agent is made as a medicinal formulation for parenteral administration and represents peptide complex with the content of low-molecular fraction from 70% to 90%, molecular mass of its peptide components in the range from 70 to 456 Da and concentration of polypeptides 2.5-2.9 mg/ml. Agent if prepared from calf kidneys (age is 12 months, not above) or pigs by extraction of tissue with acetic acid in the presence of zinc chloride. Method for preparing the agent involves freezing calf kidneys (age is 12 months, not above) or pigs at temperature -40°C (not less), keeping at temperature -20-22°C for 2 months (not less), milling adding 3% acetic acid solution in the volume ratio = 1:5 at temperature 20 ± 5°C. Extraction is carried out at constant stirring and 1% zinc chloride solution is added to the prepared homogenous suspension in the volume ratio = 50:1. Then suspension is cooled at constant stirring up to temperature 7-16°C followed by stirring for 1 h each 4 h in settling for 48 h. Extract is separated from inert substances by separating and acetone is added to extract in the volume ratio = 1:5 and kept at temperature 3-5°C for 4 h. Formed homogenized deposit is precipitated repeatedly with acetone twice (not less) and deposit containing active substance is washed out on Nutch filter with two-fold volumes of acetone cooled to temperature 7-16°C up to preparing light-gray deposit. Deposit is rubbed through metallic sieve, dried and dissolved in distilled water at room temperature and constant stirring up to the concentration of polypeptides 2.5-2.9 mg/ml. Solution is centrifuged, filtered and subjected for ultrafiltration treatment in device at anti-pressure 1.0 kgf/cm² (not above) through materials with retaining capacity 15000 Da. Glycocol is added to filtrate up to its final concentration 10-20 mg/ml at pH = 5.6-6.6 and solution is subjected for sterilizing filtration under pressure 2.0 kgf/cm² (not above), poured into ampoules by volume 2 ml and subjected for autoclaving at temperature 120°C for 8 min and under atmosphere pressure 1.1 kgf/cm². Invention provides optimal technology in isolating peptide complex from calf kidneys (age is 12 months, not above) or pigs with the content of low-molecular fraction from 70% to 90%, molecular mass of its peptide components from 70 to 456 Da and preparing aqueous solution of extract with the concentration of polypeptides 2.5-2.9 mg/ml. Invention provides both purification of the end product from impurities and enhancing its yield. Also, the isolated substance differs from the known substances early prepared from mammalian raw by molecular mass of its peptide components, absence of toxicity and apyretic properties based on the complete removing impurities.

EFFECT: improved preparing method, valuable medicinal properties of agent.

3 cl, 2 tbl, 1 dwg, 4 ex