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Preparation method for controlling pH (Potential of Hydrogen) of amoxicillin sodium/sulbactam sodium

A technology of amoxicillin sodium sulbactam sodium and amoxicillin sodium, which is applied in the field of preparation of pH value control of amoxicillin sodium sulbactam sodium, can solve the problem of not being able to effectively improve the stability of the preparation

Inactive Publication Date: 2013-09-18
SICHUAN PHARMA
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  • Claims
  • Application Information

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Problems solved by technology

[0006] The pH value range of amoxicillin sodium and sulbactam sodium for injection stipulated in the Pharmacopoeia is 8.0-10.0. Obviously, according to the above theory, this range is too large, and the pH value should be controlled within this range, but the current amoxicillin sodium for injection Moxicillin sodium and sulbactam sodium hardly control the pH value to a value smaller than the range specified by the Pharmacopoeia, so it cannot effectively improve the stability of the preparation

Method used

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Embodiment 1

[0023] The specific steps of the preparation method of the present embodiment controlling the pH value of amoxicillin sodium sulbactam sodium are as follows:

[0024] 1. Bottle washing process, pretreatment of injection bottles for sterilization:

[0025] The bottle washing process is as follows: Send the injection bottle with qualified quality into the bottle washing track, firstly make the bottle mouth of the injection bottle face up and enter the ultrasonic cleaning area, use ultrasonic waves to roughly wash the outer wall of the injection bottle with purified water, and then make the bottle mouth face up after the rough cleaning is completed. The inner wall of the injection bottle was washed with purified water with a water pressure of 0.25Mpa, then with water for injection filtered with a water pressure of 0.3Mpa and filtered through a 0.22μm filter, and finally with 0.4Mpa filtered and purified water with a 0.22μm filter. Blow dry with compressed air, turn the mouth of ...

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Abstract

The invention relates to a preparation method for controlling pH (Potential of Hydrogen) of amoxicillin sodium / sulbactam sodium. The method comprises the following steps of: processing sulbactam sodium and amoxicillin sodium with pH of 8.5 to 9.5 by physically mixing the powder in a multi-direction movement mixing way in a closed container under the protection of laminar flow based on the proportion of 2: 1; discharging the powder; weighing; barreling; sub-packaging and capping to obtain the amoxicillin sodium / sulbactam sodium. By adopting the preparation method, the pH of the prepared amoxicillin sodium / sulbactam sodium for injection can be controlled well to within the range smaller than the range specified in the pharmacopeia, various technological conditions are also controlled strictly while controlling the pH, and the moisture, relevant substances, polymers and other various important parameter indexes also can be controlled to within a great range, so that the stability of the amoxicillin sodium / sulbactam sodium for injection can be further improved, and as a result, the effect and safety on taking the amoxicillin sodium / sulbactam sodium for injection can be ensured.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a preparation method for controlling the pH value of amoxicillin sodium and sulbactam sodium. 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. [0003] The combination stability of amoxicillin sodium and sulbactam sodium is affected by factors such as pH value, temperature, moisture, content, and related substances. How to improve the effect and safety of injection medicine has always been a problem that pharmaceutical manufacturers hope to solve. The effect and safety of medication are mainly resolved from two aspects, one is the prescription design, and the other is the production and preparation process of the drug. [0004] Changes in pH are an important fac...

Claims

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Application Information

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IPC IPC(8): A61K31/43A61K9/14
Inventor 陈继源沈山
Owner SICHUAN PHARMA
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