Method of preparing a pharmaceutical composition for...

C - Chemistry – Metallurgy – 12 – N

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195/49, 167/103.

C12N 1/20 (2006.01) A61K 35/74 (2006.01) A61K 38/43 (2006.01)

Patent

CA 1062611

ABSTRACT OF THE DISCLOSURE: A method of preparing a pharmaceutical composition for alleviation of uremic symptoms. According to the invention, a species of urea, creatine, creatinine or uric acid degrading microorganism is selected and thereafter cultivated in order to determine that only one cell type grows in a culture medium containing thiamine, pyridoxine, Ca-pantothenic acid, nicotinic acid, p-amino benzoic acid, each in an amount of 0.25 mg, 0.05 mg of folic acid, 1 µg of B12 vitamin, 0.5 µg of biotine, 1.0 g of K2HPO4, 1.5 g of NaH2PO4 ? 4H2O, 0.05 g of MnC12 ? 4H2O, 0.1 g of MgSO4 ? 7H2O, 0.01 g of FeSO4 ? 7H2O, 1.0 g of yeast extract and 10 g/1000 ml of urea creatine, creatinine or uric acid as substrate at a pH value of 7.0 to 7.5, the bacterial culture being cultivated at + 28°C in a fermentation vessel, the cell mass is washed repeatedly until the substrate is removed, the washed pure cell mass is added to a 1 molar glucose solution at a ratio of 1:1 as stabilizer, whereafter the product is freezed in liquid nitrogen, thereafter lyophilized 48 to 72 hours at - 50°C and 0.03 torr, the freezedried cell mass is exposed to an inert gas, while being protected from atmospheric oxygen, and the product is mixed with a pharmaceutical carrier and then formed into an orally administra- ble composition. This composition is active in the gastro- intestinal tract of persons suffering from urea; in addition to having a specific non-protein nitrogen compounds degrading effect, it reduces the formation and concentration of nitrogen containing waste products in the organism.

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