Ertapenem for injection and preparation method thereof

Abstract

The invention discloses ertapenem for injection and a preparation method thereof, and the preparation method comprises the following steps: S1, dissolving sodium bicarbonate in water for injection to obtain an acidic solution, then adding ertapenem sodium and a protective agent into the acidic solution, and uniformly stirring and mixing; s2, adjusting the pH value of the solution obtained in the step S1 to 6.5-7.0 by adopting a sodium hydroxide solution, and then adjusting the pH value to 7.2-7.8 by adopting a sodium carbonate solution; s3, performing sterile filtration; s4, filling, freeze-drying and rubber plug filling are conducted in sequence, wherein the freeze-drying process comprises the steps that in the pre-freezing stage, standing is conducted for 2-2.5 h at the temperature ranging from-40 DEG C to 45 DEG C; first-stage drying: adjusting the pressure to be 100-120 [mu] bar, maintaining for 0.5-1 h, raising the temperature to-16 DEG C, placing for 12-13 h, then reducing the temperature to-18 DEG C, and placing for 2 days; and second-stage drying: adjusting the pressure to 180-200 [mu] bar, maintaining for 2-2.5 h, heating to 10-15 DEG C, standing for 1.5-2 h, cooling to 55-60 DEG C, and standing for 5-6 h. According to the preparation method disclosed by the invention, the pH value during solution preparation is easy to control, and the stability of the ertapenem freeze-drying agent can be improved.

Description

Technical field [0001] The present invention relates to the technical field of drug preparation, and in particular to the injection of Erhe cultivation and its preparation method thereof. Background technique [0002] Erhabing is a broad-spectral carbon wholeicone antibiotic, suitable for the following symptoms: [0003] Secondary abdominal infection, complex skin and attachment infection, community acquisition pneumonia, complex urethral infection, acute pelvic infection and bacteramia. [0004] The commonly used dosage forms in Erhabse is a syringe, specifications of 1 g. The preparation process of Erthamine Nano-drying agent (powder needle) includes liquidation, filtration, filling and drying. [0005] In the prior art, in order to improve the stability of the nanoprotary dry agent, sodium bicarbonate is added during the preparation, and the pH is adjusted by sodium hydroxide, although in advance, dissolve the sodium bicarbonate solution in advance in advance. In, then, the pH...

AI Technical Summary

Problems solved by technology

However, the reason why the stability of the ertapenem freeze-dried preparation can be improved by adjusting the pH value through strong alkali sodium hydroxide is that the pH value of the ertapenem freeze-dried preparation is adjusted to an appropriate range, but, due to the Dry agent strong alkali sodium hydroxide is highly alkaline and it is difficult to control the amount added. It is necessary to use a precise drop control system. If there is an error in the drop control system, the pH value adjustment will exceed the appropriate range, which will affect the freeze-drying of ertapenem. agent stability

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