2 results about "Carbetocin" patented technology

This invention discloses a carbetocin injection solution and its preparation process. The raw materials for the carbetocin injection solution include at least carbetocin, methionine, disodium edetate, an antibacterial agent, a pH adjuster, and a solvent. The pH of the carbetocin injection solution is 4.0-4.5. The concentration of carbetocin is 50 μg / ml-80 μg / ml, the concentration of methionine is 10 mg / ml-20 mg / ml, the concentration of disodium edetate is 5 mg / ml-10 mg / ml, and the concentration of the antibacterial agent is 2 mg / ml-3 mg / ml. By controlling the concentrations of carbetocin, methionine, disodium edetate, and the antibacterial agent, and simultaneously adjusting the pH of the injection solution to 4.0-4.5, this invention eliminates the need for nitrogen purging during the preparation process, thereby enabling the prepared carbetocin injection solution to exhibit high antioxidant properties and stability, allowing for long-term storage at room temperature.

This invention provides a method for determining the content of the antioxidant methionine in carbetocin injection, comprising the following steps: Preparation of the reference solution: Accurately weigh an appropriate amount of methionine reference standard, dissolve it in water, and quantitatively dilute it to prepare a solution containing 1 mg per 1 ml. Preparation of the test solution: Take the product, and the test solution is obtained. Determination method: Accurately measure 10 μl each of the test solution and the reference solution, inject them separately into the liquid chromatograph, record the chromatogram until twice the retention time of the methionine peak, and calculate the methionine content in carbetocin injection by peak area using the external standard method. This invention uses high-performance liquid chromatography (HPLC), and by optimizing the determination method by changing conditions such as the mobile phase ratio and comparing it with traditional detection methods, it demonstrates that this invention is a more stable, effective, and rapid method for determining the methionine content.