METHOD FOR PREPARING ALPHA-FETOPROTEIN PREPARATION TABLET Russian patent published in 2008 - IPC A61K9/20 A61K38/17 A61K35/16 

FIELD: medicine, pharmaceutical industry.

SUBSTANCE: invention proposes a method for making tablets of alpha-fetoprotein preparation. Method involves mixing alpha-fetoprotein with a stabilizing agent, addition of a filling agent consisting of microcrystalline cellulose and potato starch or lactose, coating the prepared mixture by envelope consisting of acetylphthalylcellulose in the following ratio of components, weight%: alpha-fetoprotein, 0.01-0.03; stabilizing agent, 8.57-14,28; microcrystalline cellulose, 40-45.7; potato starch or lactose, 40-45.7, and acetylphthalylcellulose, 1.14-2.85. Rheopolyglucin is used as a stabilizing agent, and alpha-fetoprotein is obtained from abortive, cord or placental blood by separation of inert proteins from blood by centrifugation, fractionation of supernatant with ammonium sulfate or sodium sulfate, or ethyl alcohol for 1 h, repeated centrifugation of solution, carrying out the first chromatography treatment of supernatant on an affinity sorbent using Sepharose CL-4B, elution of alpha-fetoprotein with 0.1 M glycine-HCl buffer solution at pH 2.5 up to obtaining zero values of optical density at wavelength 280 nm, and the following chromatography treatment on an affinity sorbent using Sepharose CL-4B containing immobilized antibodies against human IgG and dialysis of alpha-fetoprotein solution against 0.15 mole/l of sodium chloride solution. The end product is diluted with rheopolyglucin up to the concentration alpha-fetoprotein 0.9 mg/ml and that of dextran 10 mg/ml. Invention provides increasing yield of alpha-fetoprotein and maximal purity of the end product, increasing stability of alpha-fetoprotein in storage, expanding region of its using and design of preparation of prolonged effect.

EFFECT: improved preparing method.

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