Preparation method of amoxicillim sodium and sulbactam sodium for injection

Abstract

This invention relates to a preparation method of amoxicillim sodium and sulbactam sodium for injection. The preparation method comprises that: amoxicillin sodium and sulbactam sodium are subjected to a multi-direction movement and physical powder mixing combined treatment in a closed container under gas laminar flow protection according to a ratio of 2:1, and weighing and barreling are performed after powder is discharged, wherein the amoxicillin polymer content (calculated as amoxicillin) in the amoxicillin sodium is less than 0.4%; and nitrogen gas is filled into a sterilization pretreated injection bottle, then the amoxicillin sodium and sulbactam sodium mixed powder is sub-filled into the pretreated injection bottle, nitrogen gas is continuously introduced after sub-filling, a pretreated rubber plug automatically covers through a sub-filling machine, the obtained bottle is conveyed into a capping machine, and aluminum cap capping is performed to obtain the amoxicillim sodium and sulbactam sodium. According to the present invention, amoxicillin sodium with the polymer content of not more than 0.4% is selected to match with sulbactam sodium to prepare the amoxicillim sodium and sulbactam sodium injection preparation, such that drug stability is better, and the injection preparation is safe.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a preparation method of amoxicillin sodium sulbactam sodium for injection. Background technique [0002] Amoxicillin Sodium Sulbactam Sodium for Injection is a compound preparation of Amoxicillin Sodium and β-lactamase inhibitor Sulbactam Sodium. It is white or off-white powder or crystalline powder, which is very easy to attract moisture. Its antibacterial activity is significantly enhanced compared with a single drug, and has the following advantages: [0003] 1. Low toxicity and mild adverse reactions [0004] Amoxicillin sodium binds to the penicillin-binding protein (PBP) on the bacterial cell membrane to hinder the synthesis of bacterial cell wall mucopeptides, resulting in bacterial cell rupture and death. Mammalian cells have no cell wall, so amoxicillin sodium has very low toxicity to human cells and has no effect on human cells at effective antibacterial concentrat...

AI Technical Summary

Problems solved by technology

[0008] At present, the preparation methods of injection powder injections that have been published are all conventional preparation methods of injection powder preparations. There is no targeted design and verification based on the performance of the amoxicillin sodium sulbactam sodium product itself, and each powder injection The physical and chemical properties and drug properties of preparations are different. If the method of conventionally prepared powder for injection is used, the acidity of the product, the clarity and color of the solution, related substances, content and other parameters cannot be achieved. Better control, and the polymer is not controlled in the national standard, so the quality of the product cannot be fully guaranteed

In order to achieve better control of the above-mentioned various parameter indicators, the process design of the entire preparation and the parameters in each process must be fully designed and verified according to the physical and chemical properties and medicinal properties of the specific product. The technical process design and the parameter control requirements in each process are difficult points. The existing preparation process cannot accurately ensure that each parameter can be within a better parameter range, and the effect and safety of injection medicine cannot be guaranteed.