Novel solid preparation containing block copolymer and anthracycline anticancer agent and process for producing the same
A technology of solid preparations and anticancer agents, applied in the field of anthracycline anticancer agents, capable of solving problems not specifically described
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Embodiment 1
[0075] 1000 mg of the retarded copolymer obtained according to the reference example described below, and 18.5 g of sodium bicarbonate were added to 20 ml of the injection solvent, stirred and dissolved at 60 to 70°C, and then the solution was cooled to room temperature. 200mg of doxorubicin hydrochloride and 1000mg of sucrose were separately stirred and dissolved in 40ml of injection solvent. The two solutions were mixed, and the pH was controlled at 6 with sodium hydroxide and hydrochloric acid, and then the total amount was controlled to 100 ml with the injection solvent. The solution was filtered through a membrane filter with a pore size of 0.45 μm, and then filtered and sterilized through a membrane filter with a pore size of 0.2 μm. The solution was filled into vials of 5 ml each, lyophilized, and then the vials were sealed to produce a solid preparation for injection. 5 ml of injection solvent was added to the formulation to re-dissolve the formulation to obtain an aqueous...
Embodiment 2
[0077]1000 mg of the retarding copolymer (same as in Example 1), and 8.8 g of sodium hydroxide were added to 20 ml of injection solvent, stirred and dissolved at 60 to 70°C, and then the solution was cooled to room temperature. 200 mg of doxorubicin hydrochloride and 800 mg of trehalose were stirred and dissolved in 40 ml of injection solvent. The two solutions were mixed, and the pH was controlled at 6 with sodium hydroxide and hydrochloric acid, and then the total amount was controlled to 100 ml with the injection solvent. The solution was filtered through a membrane filter with a pore size of 0.45 μm, and then filtered and sterilized through a membrane filter with a pore size of 0.2 μm. The solution was filled into vials of 5 ml each, lyophilized, and then the vials were sealed to produce a solid preparation for injection. 5 ml of injection solvent was added to the formulation to re-dissolve the formulation to obtain an aqueous solution of the retarding copolymer-doxorubicin co...
Embodiment 3
[0079] 1000 mg of the retarding copolymer (same as in Example 1), and 18.5 g of sodium bicarbonate were added to 20 ml of injection solvent, stirred and dissolved at 60 to 70°C, and then the solution was cooled to room temperature. 200 mg of doxorubicin hydrochloride and 1000 mg of maltose were stirred and dissolved in 40 ml of injection solvent. The two solutions were mixed, and the pH was controlled at 6 with sodium hydroxide and hydrochloric acid, and then the total amount was controlled to 100 ml with the injection solvent. The solution was filtered through a membrane filter with a pore size of 0.45 μm, and then filtered and sterilized through a membrane filter with a pore size of 0.2 μm. The solution was filled into vials of 5 ml each, lyophilized, and then the vials were sealed to produce a solid preparation for injection. 5 ml of injection solvent was added to the formulation to re-dissolve the formulation to obtain an aqueous solution of the retarding copolymer-doxorubicin...
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