| 摘要 |
The invention relates to a high concentration parenteral composition of paracetamol or a pharmaceutically acceptable salt thereof, provided for delivering a therapeutic dose of 500 mg paracetamol in 2-3 ml in a water solvent system, wherein the concentration of paracetamol or a pharmaceutically acceptable salt thereof is 166-250 mg/ml and viscosity is 7-28 cps at 25°C, the solvent system comprising glycofurol, ethanol and water or glycofurol, ethanol, polyethylene glycol and water. The invention also relates to a process for preparing said composition, comprising: a. solubilising the requisite quantities of paracetamol or a pharmaceutically acceptable salt thereof in a solvent system, such as glycofurol, ethanol and water or glycofurol, ethanol, polyethylene glycol and water, under inert atmosphere; b. adding antioxidant, chelating agent, benzyl alcohol; c. adjusting pH between 4 to 8; d. adjusting the volume of the solution to a preset volume; e. filtering the solution through 0.22 micron filter media; wherein the steps b and c are optional. The compositions remain stable clear and transparent for at least 6 hours after dilution. |
