| abstract |
The invention discloses ertapenem for injection and a preparation method thereof. The preparation method comprises the following steps: S1, dissolving sodium bicarbonate in water for injection to obtain an acidic solution, and then adding ertapenem sodium and a protective agent into the acidic solution , stirring and mixing; S2, firstly using sodium hydroxide solution to adjust the pH value of the solution obtained in step S1 to 6.5-7.0, and then using sodium carbonate solution to adjust the pH value to 7.2-7.8; S3, sterile filtration; S4, filling sequentially , freeze-drying and filling rubber stopper. The freeze-drying process is as follows: pre-freezing stage: place at -40-45°C for 2-2.5h; first-stage drying: adjust the pressure to 100-120μbar, maintain for 0.5-1h, Raise the temperature to ‑16℃ for 12‑13h, then lower the temperature to ‑18℃ for 2 days; the second stage of drying: adjust the pressure to 180‑200μbar, maintain for 2‑2.5h, heat up to 10℃‑15℃ and place for 1.5‑2h, Then cool down to 55-60℃ and place for 5-6h. The preparation method of the present invention is not only easy to control the pH of the solution preparation, but also can improve the stability of the ertapenem freeze-dried agent. |