Amoxicillin and clavulanate potassium injection and preparation method thereof

Abstract

The invention belongs to the technical field of medical technology, and particularly relates to an amoxicillin and clavulanate potassium injection and a preparation method of the amoxicillin and clavulanate potassium injection. The amoxicillin and clavulanate potassium injection includes amoxicillin sodium, potassium clavulanate and a pH regulator. The preparation method comprises the steps of crushing and mixing the amoxicillin sodium, the potassium clavulanate and the pH regulator uniformly through air flows according to certain proportion, then respectively packaging the mixture into penicillin bottles, controlling the water content to be 0.5%, filling nitrogen for protection, plugging, rolling a cover and finally packaging. According to the invention, the obtained product is stable in quality, the problems of the color changing and the deterioration caused by the easy oxidization of the similar products can be solved, the product quality is improved, and high economical benefits are obtained.

Description

technical field

[0001] The invention belongs to the field of western medicine preparations, and in particular relates to an injection of amoxicillin sodium and clavulanate potassium and a preparation method thereof. Background technique

[0002] Amoxicillin is a β-lactam antibiotic, which mainly affects the synthesis of bacterial cell walls by binding to bacterial penicillin-binding proteins (PBPs), causing bacterial cells to swell and rupture and die. Clavulanic acid is a natural β-lactam antibiotic produced by bacteria. It contains a β-lactam ring in its structure, and its antibacterial effect is weak, but it has a strong broad-spectrum enzyme inhibitory effect. It is used in combination with β-lactam antibiotics, which can protect amoxicillin from being inactivated by 5 broad-spectrum enzymes TEN-1, SHV-1, PSE-4, KI and K-CAZ to varying degrees, thereby improving Amoxicillin has the effect of killing drug-resistant bacteria, has a broad-spectrum antibacterial effect on a...

Examples

Embodiment 1

[0016] prescription:

[0017] Amoxicillin Sodium 2497g

[0018] Potassium clavulanate 498g

[0019] Sodium bicarbonate 2.625g

[0020] Sodium acetate 0.375g

[0021] Preparation method: Weigh the prescribed amount of amoxicillin sodium, potassium clavulanate, sodium bicarbonate and sodium acetate, and then airflow pulverize them respectively, then sieve the powder with a particle size of 75-100 μm, and use a V-type high-efficiency mixer Mix for 20 minutes and verify the degree of mixing. Keep the ambient temperature at 18°C, humidity at 18%, and control the moisture within 0.5%. Turn on the filling machine and nitrogen device, adjust the filling volume and start filling. After sub-packaging, press the plug, roll the aluminum cover, and pack it.

Embodiment 2

[0023] prescription:

[0024] Amoxicillin Sodium 2498g

[0025] Potassium clavulanate 499g

[0026] Sodium bicarbonate 1.3125g

[0027] Sodium acetate 0.1875g

[0028] Preparation method: Weigh the prescribed amount of amoxicillin sodium, potassium clavulanate, sodium bicarbonate and sodium acetate, and then airflow pulverize them respectively, then sieve the powder with a particle size of 75-100 μm, and use a V-type high-efficiency mixer Mix for 20 minutes and verify the degree of mixing. Keep the ambient temperature at 18°C, humidity at 18%, and control the moisture within 0.5%. Turn on the filling machine and nitrogen device, adjust the filling volume and start filling. After sub-packaging, press the plug, roll the aluminum cover, and pack it.

Embodiment 3

[0030] prescription:

[0031] Amoxicillin Sodium 2498g

[0032] Potassium clavulanate 496g

[0033] Sodium bicarbonate 16.625g

[0034] Sodium acetate 2.325g

[0035] Preparation method: Weigh the prescribed amount of amoxicillin sodium, potassium clavulanate, sodium bicarbonate and sodium acetate, and then airflow pulverize them respectively, then sieve the powder with a particle size of 75-100 μm, and use a V-type high-efficiency mixer Mix for 20 minutes and verify the degree of mixing. Keep the ambient temperature at 18°C, humidity at 18%, and control the moisture within 0.5%. Turn on the filling machine and nitrogen device, adjust the filling volume and start filling. After sub-packaging, press the plug, roll the aluminum cover, and pack it.

technical field

[0001] The invention belongs to the field of western medicine preparations, and in particular relates to an injection of amoxicillin sodium and clavulanate potassium and a preparation method thereof. Background technique

[0002] Amoxicillin is a β-lactam antibiotic, which mainly affects the synthesis of bacterial cell walls by binding to bacterial penicillin-binding proteins (PBPs), causing bacterial cells to swell and rupture and die. Clavulanic acid is a natural β-lactam antibiotic produced by bacteria. It contains a β-lactam ring in its structure, and its antibacterial effect is weak, but it has a strong broad-spectrum enzyme inhibitory effect. It is used in combination with β-lactam antibiotics, which can protect amoxicillin from being inactivated by 5 broad-spectrum enzymes TEN-1, SHV-1, PSE-4, KI and K-CAZ to varying degrees, thereby improving Amoxicillin has the effect of killing drug-resistant bacteria, has a broad-spectrum antibacterial effect on a...

Examples

Embodiment 1

[0016] prescription:

[0017] Amoxicillin Sodium 2497g

[0018] Potassium clavulanate 498g

[0019] Sodium bicarbonate 2.625g

[0020] Sodium acetate 0.375g

[0021] Preparation method: Weigh the prescribed amount of amoxicillin sodium, potassium clavulanate, sodium bicarbonate and sodium acetate, and then airflow pulverize them respectively, then sieve the powder with a particle size of 75-100 μm, and use a V-type high-efficiency mixer Mix for 20 minutes and verify the degree of mixing. Keep the ambient temperature at 18°C, humidity at 18%, and control the moisture within 0.5%. Turn on the filling machine and nitrogen device, adjust the filling volume and start filling. After sub-packaging, press the plug, roll the aluminum cover, and pack it.

Embodiment 2

[0023] prescription:

[0024] Amoxicillin Sodium 2498g

[0025] Potassium clavulanate 499g

[0026] Sodium bicarbonate 1.3125g

[0027] Sodium acetate 0.1875g

[0028] Preparation method: Weigh the prescribed amount of amoxicillin sodium, potassium clavulanate, sodium bicarbonate and sodium acetate, and then airflow pulverize them respectively, then sieve the powder with a particle size of 75-100 μm, and use a V-type high-efficiency mixer Mix for 20 minutes and verify the degree of mixing. Keep the ambient temperature at 18°C, humidity at 18%, and control the moisture within 0.5%. Turn on the filling machine and nitrogen device, adjust the filling volume and start filling. After sub-packaging, press the plug, roll the aluminum cover, and pack it.

Embodiment 3

[0030] prescription:

[0031] Amoxicillin Sodium 2498g

[0032] Potassium clavulanate 496g

[0033] Sodium bicarbonate 16.625g

[0034] Sodium acetate 2.325g

[0035] Preparation method: Weigh the prescribed amount of amoxicillin sodium, potassium clavulanate, sodium bicarbonate and sodium acetate, and then airflow pulverize them respectively, then sieve the powder with a particle size of 75-100 μm, and use a V-type high-efficiency mixer Mix for 20 minutes and verify the degree of mixing. Keep the ambient temperature at 18°C, humidity at 18%, and control the moisture within 0.5%. Turn on the filling machine and nitrogen device, adjust the filling volume and start filling. After sub-packaging, press the plug, roll the aluminum cover, and pack it.

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