Antibiotic amoxicillin refining equipment cylinder cone airtight filter washing machine

Amoxicillin, also known as amoxycillin or amoxycillin, is the most commonly used semi-synthetic penicillin-type broad-spectrum β-lactam antibiotic. It is a white powder with a half-life of about 61.3 minutes. Stable under acidic conditions, the gastrointestinal absorption rate reaches 90%. Amoxicillin has a strong bactericidal effect and a strong ability to penetrate cell membranes.

It is one of the most widely used oral semi-synthetic penicillins at present. Its preparations include capsules, tablets, granules, dispersible tablets, etc. Now it is often combined with clavulanic acid to make dispersible tablets. Amoxicillin is an antibiotic that is often used to treat many bacterial infections. It is used for middle ear infections, strep throat, pneumonia, skin infections, and urinary tract infections, among others.

It is clinically used to treat tonsillitis, laryngitis, pneumonia, chronic bronchitis, urinary system infection, skin and soft tissue infection, suppurative pleurisy, liver and gallbladder system infection, sepsis, typhoid fever, dysentery, etc.

In the past few years, the global market of amoxicillin has developed steadily, with an average growth rate of 1.12%. In 2017, the global revenue of amoxicillin was close to 42.8 million US dollars, and the actual production was about 2.6 billion boxes.

In 2018, the total value of the global amoxicillin market reached 29.31 billion yuan, and it is expected to grow to 31.09 billion yuan in 2025.

The current domestic amoxicillin process produces products with small average particle size, high coefficient of variation, high residual impurities, and poor product stability. The validity period of domestic manufacturers is two years, while the international level is more than three years.

Improve product quality level and stability mainly through the following ways:

(1) Strengthen personnel training to achieve the stability of process control;

(2) Improve the degree of process automation control; technical transformation of equipment process applicability;

(3) Control the quality and stability of raw and auxiliary materials, especially the quality of the main raw materials 6-APA and p-hydroxyphthalic anhydride ammonium potassium salt;

(4) Optimization of the process parameters of each step of the main reaction;

(5) The application of inspection technology in process control and the progress in impurity analysis of finished products provide a basis for improving product quality and clarifying the direction of process improvement.

The quality of crystallization in production is expressed by the purity of the crystals, the size of the particles and the crystal form. The crystal particles should not be too fine, otherwise it will be difficult to wash, filter and separate in the subsequent sequence, which will affect the production efficiency, product yield and quality, resulting in high residual impurities and poor product stability. Difficulties in preparation processing, coupled with too small particles, too large specific volume, and poor fluidity, also bring inconvenience to the sub-packaging of products.

Therefore, improving the crystal form, particle size and particle size distribution of the product is one of the ways to improve the purity and stability of the product and the applicability of the preparation.

Antibiotic amoxicillin refining equipment cylinder cone airtight filter washing machine process steps

Compared with the existing technology, the advantages of applying the method of refining the antibiotic amoxicillin in the airtight pressurized filter washing machine to the refining and purification process of amoxicillin are: less colored impurities, high yield of amoxicillin, good product quality, and at the same time Recycled phenylacetic acid with qualified product quality is easy to be applied in production.

The temperature of the reaction solution was lowered, and then dichloromethane was added.

Under stirring conditions, hydrochloric acid with a mass concentration of 20-30% was added, and the dichloromethane phase was separated; secondary extraction and three extractions were performed to finally obtain an extracted aqueous phase containing 6-APA, and the dichloromethane phase was combined;

(2) Amoxicillin reaction preparation steps

Ammonia water is added to the extracted aqueous phase containing 6-APA, and the residual dichloromethane in the extracted aqueous phase is removed under reduced pressure at room temperature; the obtained solvent-free 6-APA solution is concentrated by pressure filtration; the synthesis reaction is separated to obtain A crude moxicillin; step

(3) Acidification and dissolution

Add hydrochloric acid with a mass concentration of 20-30% to the crude product of amoxicillin under stirring by the spindle of the all-in-one machine for crystallization, filtration, washing and drying to completely dissolve the amoxicillin, and then filter;

(4) crystallization

Under cooling conditions, add ammonia water with a mass concentration of 6-10% to the amoxicillin solution, control the pH of the feed solution to 4.8-5.2, and grow crystals for 90-120 minutes under cooling conditions;

(5) Suction filtration, washing and drying

Suction filter the amoxicillin crystallization liquid by using a crystallization filtration washing and drying multifunction machine, wash with purified water and acetone respectively, and then dry the wet powder of amoxicillin in vacuum at low temperature at a temperature of 40-60°C and a vacuum degree of ≥ 0.085MPa, after drying, amoxicillin dry powder is obtained.