AGENT NORMALIZING REPRODUCTIVE FUNCTION IN MEN AND METHOD FOR ITS PREPARING Russian patent published in 2007 - IPC A61K35/48 A61P15/08 

FIELD: medicinal industry.

SUBSTANCE: invention relates to a method for isolating active substance from mammalian testicles and preparing a medicinal formulation for parenteral administration that can be used in medicine as agent normalizing the reproductive function in men. 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 75-228 Da, and concentration of polypeptides 2.5-2.9 mg/ml. Agent is prepared from mature young bull testicles (age is 12 months, not above) or pigs by tissue extraction with acetic acid in the presence of zinc chloride. Proposed method for preparing agent involves freezing mature young bull testicles (age is 12 months, not above) or pigs at temperature -40°C (not less), keeping at temperature -20-22°C for two months (not less), milling and 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 followed by cooling at constant stirring up to temperature 7-16°C and the following stirring for 1 h in 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, kept at temperature 3-5°C for 4 h. Formed homogenized deposit is precipitated with acetone repeatedly 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, dissolved in distilled water at room temperature at 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 under anti-pressure 1.0 kgf/cm² (not above) through materials with retaining capacity 15000 Da. Glycocol is added to ultrafiltrate to its final concentration 10-120 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 in 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 with the content of low-molecular fraction from 70% to 90%, molecular mass of its peptide components in the range 75-228 a, and preparing aqueous solution of extract with the concentration of polypeptides 2.5-2.9 mg/ml. Invention provides both purifying the prepared product from impurities and to enhance its yield. 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 properties of agent.

3 cl, 2 tbl, 1 dwg, 4 ex