| 摘要 |
FIELD: medicine, endocrinology, pharmaceutical technology, pharmacy. ^ SUBSTANCE: invention relates to preparing insulin preparations with the prolonged effect used in therapy of diabetes mellitus. Invention relates to a method for preparing the pharmaceutical composition suspension based on domestic industry genetic engineering (recombinant) human insulin comprising protamine sulfate and insulin in the concentration 100 IU/ml designated for bottling. Method for preparing the pharmaceutical composition based on genetic engineering human insulin in small bottles involves preparing insulin an aqueous suspension in the concentration of insulin 100 IU/ml comprising zinc chloride, protamine sulfate, sodium hydrogen phosphate, glycerol, phenol and meta-cresol additionally, carrying out the sterilizing filtration and crystallization. Method involves preliminary preparing a buffer solution with pH = 8.3-8.5 at stirring comprising 2.4 g/ml of sodium hydrogen phosphate, 1.4-1.6 mg/ml of meta-cresol, 0.5-0.7 mg/ml of phenol, 15-17 mg/ml of glycerol and water. Then method involves preparing insulin solution by successive addition of 0.35-0.45 mg/ml of protamine sulfate, substance of human insulin, 1% aqueous solution of zinc chloride in the content of zinc in the medicinal formulation 0.025-0.035 mg/100 IU of insulin and water acidified to pH = 3.1-3.3. Solutions are subjected for sterilizing filtration and crystallization is carried out before bottling and holding the prepared composition at temperature 12-16°C and stirring for 16-24 h. Invention solves the problem for enhancing effectiveness of the technological process for preparing the pharmaceutical composition suspension. Invention can be used in medicinal industry for preparing the domestic genetic engineering (recombinant) suspension of protamine-human insulin in small bottles. ^ EFFECT: improved preparing method. ^ 1 tbl, 2 ex |
