Patent EA-003369-B1 (EA)
Title: Novel pharmaceutical composition for use in emergency treatment and preparation method thereof
IPC: A61K31/718
Filed: 1999-04-16
Abstract: 1. A pharmaceutical composition comprising 1.5-6.9 % (w/v) of one or more substances selected from sodium chloride, sodium bicarbonate, potassium chloride, magnesium sulfate, calcium chloride, calcium gluconate, calcium lactate, sodium lactate, sodium acetate and Tris (Hydroxy methyl) aminomethane, and 3-18 % (w/v) of one or more substances selected from hydroxyethylstarch, dextran, carboxymethylstarch, polyvinylpyrrolidone (PVP), gelatin derivatives, condensed glucose, glucose, fructose, lactose, glycerin, xylitol, sodium, alginate, N-2-hydroxypropylacrylamide, ethylene epoxide-polypropylene glycol, pectin, mannitol, and pentahydroxyethylstarch; as well as the remainder of conventional injections, as long as sodium chloride is not less than 1.5 % (w/v), and the concentration of sodium ion is not more than that of 6.9 % (w/v) sodium chloride solution or equivalent. 2. The pharmaceutical composition of Claim 1, wherein the composition contains 4.2 +- 0.2g sodium chloride and 7.6 +- 0.6g hydroxyethylstarch per 100 ml. 3. The pharmaceutical composition of Claim 1 or 2, wherein the conventional injections are selected from water for injection, physiological saline, balanced buffers, glucose solution, sodium lactate solution, sodium acetate solution, Tris solution, and glucose and sodium chloride solution. 4. The pharmaceutical composition of Claim 1 or 2, wherein hydroxyethylstarch contains at least 10% hydroxyethylstarch with molecular weight of 25,000-45,000. 5. The pharmaceutical composition of Claim 1, wherein gelatin derivatives have, molecular weight of 20,000 - 35,000, and are selected from urea-conjugated gelatin, modified liquid gelatin, oxidized polygelatin and degraded gelatin polypeptide. 6. The pharmaceutical composition of Claim 1, wherein dextran has molecular weight of 40,000-230,000; carboxymethylstarch has molecular weight of 30,000-80,000, PVP has molecular weight of 5,000-700,000, condensed glucose has molecular weight of 8, 000 - 12,000, sodium alginate has molecular weight of 20,000-26,000, pectin has molecular weight of 20,000 - 40,000; pentahydroxyethylstarch has molecular weight of 264,000. 7. A method for preparing the pharmaceutical composition of Claim 1, comprising: dissolving 3-18g of one or more substances selected from hydroxyethylstarch, dextran, carboxymethylstarch, PVP, gelatin derivatives, condensed glucose, glucose. fructose, lactose, glycerin, xylitol, sodium alginate, N-2-hydroxypropylacrylamide, ethylene epoxide-polypropylene glycol, pectin, mannitol, and pentahydroxyethylstarch, in total of 100 ml of one injection or mixture of several injections selected from water for injection, physiological saline, balanced buffers, glucose solution, sodium lactate solution, sodium acetate solution, Tris solution, and glucose and sodium chloride solution; the adding 1.5g sodium chloride and 0-5.4g of one or more substances selected from sodium chloride, sodium bicarbonate, potassium chloride, magnesium sulfate, calcium chloride, calcium gluconate, calcium lactate, sodium lactate, sodium acetate, and Tris with the proportion described above, then mixing, dissolving, to obtain the composition of the present invention.