药剂学实验PreparationofVitaminCInjections维生素C注射剂.docVIP

Preparation of Ascorbic Acid Injections Abstract Injections is a kind of the most important dosage forms, which is used widely and couldn’t be replaced in clinical treatment. Injections play an important role in saving the critical patients. In the preparation of ascorbic acid injection, the means to enhance the stability of vitamin C are adopted, and pay attention to the key points in the manufacturing process of sterile preparation. Key wordsvitamin C; sterile preparation; ascorbic acid injection; dosage forms; pharmaceutics Introduction Injection Injections are sterile products containing medicaments intended for parenteral administration into the body, including solutions, emulsions, suspensions as well as sterile powders or concentrates solutions, which, by the addition of suitable solvents before use, form solutions or suspensions. The production of injection must follow rigid aseptic procedures. In the preparation of parenteral solutions, the required ingredients are dissolved in water for injection according to GMP. Then the solutions are usually filtered until sparkling clear through a membrane type filter after filtration, are transferred into the final containers as rapidly as possible and with the least possible exposure. The products are then sterilized, preferably autoclaved, and samples of the finished products are tested for sterilization and pyrogens. The requirements for injection are as following: sterile, no-pyrogen, valid clarity, safe for using, atoxic, non-irritant, valid stability, pH close to that of human blood(general 4~9), qualified content. The osmotic pressure of intravenous injection with a big amount of dose or infusion should be isoosomotic. Vitamin C Vitamin C(Ascorbic acid) is recommended for the prevention and treatment of scurvy, facilitating the wound and bone fracture, preventing coronary heart disease and so on.It is reasonably stable in the solid state. In the wet state or solution, it is easily oxidized to dehydroascorbic a