Sterile API Filtering And Drying Equipment For Amoxicillin Material

Amoxicillin is a most commonly used semi-synthetic penicillin broad-spectrum β-lactam antibiotic. It is a white powder with a half-life of approximately 61.3 minutes. Stable under...

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Sterile API Filtering and Drying Equipment For Amoxicillin Material


Amoxicillin is a most commonly used semi-synthetic penicillin broad-spectrum β-lactam antibiotic. It is a white powder with a half-life of approximately 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. Its preparations are capsules, tablets, granules, dispersible tablets, etc., and it is often used in combination with clavulanic acid to make dispersible tablets. Amoxicillin is an antibiotic often used to treat many bacterial infections. It can be used for middle ear infections, streptococcal laryngitis, pneumonia, skin infections and urinary tract infections. Clinically used to treat tonsillitis, laryngitis, pneumonia, chronic bronchitis, urinary system infection, skin and soft tissue infection, suppurative pleurisy, hepatobiliary system infection, sepsis, typhoid fever, dysentery, etc.


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In the past few years, the global market of amoxicillin has developed steadily, with an average growth rate of 1.12%. In 2017, Amoxicillin's global income was close to US$4280 million, and actual production was about 2.6 billion boxes. In 2018, the total value of the global amoxicillin market reached RMB29.31 billion , and it is expected to grow to RMB31.09 billion  in 2025.


The quality of crystals 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 the subsequent washing, filtration and separation will cause difficulties, affecting the production efficiency, product yield and quality, resulting in high residual impurities in the product, poor product stability, and fine particles will be charged with static electricity. Difficulties in processing the preparation, coupled with too small particles, too large specific volume, and poor fluidity, also cause inconvenience to the sub-packaging of the product. 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 formulation。


Wuxi Shuangrui Machinery Co., Ltd. has carried out a lot of design and development work, and finally developed a multi-functional cone-cone reaction filter dryer integrating filtration, washing and drying, and successfully applied for a patent (Patent No.: ZL201721560677.6.) , Achieve a major improvement in equipment technical performance, from structural design to application are closely followed by the corresponding regulatory requirements of the pharmaceutical industry. The equipment has three main functions of filtration, washing and drying, and also has multiple functions of reaction, extraction, crystallization, concentration, evaporation, mixing, crushing and so on. It belongs to high-tech equipment and has the following advantages:


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1. Multi-purpose for one machine, can complete various operations such as reaction, extraction, filtration, repeated filtration washing, drying, etc. in one machine, and get the finished product directly.


2. Closed operation, especially suitable for handling flammable, explosive, toxic or highly toxic dangerous products and contaminated delicious food, biological products and medicines.


3. The cylinder jacket, cone jacket and hollow shaft and hollow spiral belt simultaneously heat or cool the material, with high thermal efficiency and low energy consumption.


4. The special design of the agitating screw can make the materials mix very uniformly in the reaction, filtration, washing and drying stages, so that the working efficiency of the whole machine is very high.


5. In the filtration stage, due to the good fit between the spiral belt and the filter medium, the material can be filtered under the condition of a thin filter cake, and the filtration efficiency is high.


6. Simplify and shorten the technological process, occupy a small area, and greatly save the investment in plant and equipment.


7. Convenient operation, low labor intensity and good quality of processed products.


Antibiotic Amoxicillin Refining Equipment Filter Washing and Drying three in one Equipment Working Principle

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The new filter washing and drying machine is a cone-shaped structure. A heating jacket is provided on the cylinder and the lower cone to heat or cool the materials. A hollow shaft and a variable angle and variable lead hollow are provided inside the multifunctional machine The spiral stirring device stirs, stirs and lifts the materials, and pushes out the materials when discharging. A conical filter device with a more complicated structure is provided in the lower cone, and a specially designed non-dead-angle quick-opening discharge device or a non-dead-angle pneumatic discharge ball valve is provided at the bottom of the equipment.


In the reaction stage, the reaction materials are added from the top. The unique stirring structure allows the materials to be stirred very uniformly in the machine, and is heated or cooled at the same time through the cylinder jacket, cone jacket and hollow shaft, hollow spiral blade. Make the material fully react in the machine. In the filtration stage, the machine can filter and dry the materials in the machine by pressurization or vacuum filtration, and add washing liquid, so that the materials can be automatically re-pulp washed in the machine for many times, and then dried after reaching the washing requirements. In the drying stage, the barrel jacket, cone jacket, hollow shaft, and hollow spiral belt simultaneously heat the material and evacuate the top, vacuum-dry the material at low temperature, and automatically seal the material after drying.


Antibiotic Amoxicillin Refining Equipment Filter Washing and Drying three in one Equipment Process steps


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Compared with the current technology, the refining method of antibiotic amoxicillin in the closed pressure filtration and washing machine is applied to the amoxicillin purification and purification process. The advantages are: less colored impurities, high yield of amoxicillin, good product quality, and Phenylacetic acid with qualified product quality can be easily applied in production.


1.Extraction step

The reaction solution was cooled down, and dichloromethane was added. Under stirring conditions, add hydrochloric acid with a mass concentration of 20 to 30%, and separate the dichloromethane phase; perform two extractions and three extractions, and finally obtain an extraction aqueous phase containing 6-APA, and combine the dichloromethane phases;

 

2.Amoxicillin reaction preparation steps

Ammonia water was added to the extraction aqueous phase containing 6-APA, and the methylene chloride remaining in the extraction aqueous phase was removed under reduced pressure at room temperature; the resulting desolvent 6-APA solution was subjected to pressure filtration and concentration; Moxilin crude; steps

 

3.Acidification and dissolution

Under the stirring of the main shaft of the crystal filtering, washing and drying all-in-one machine, add 20-30% hydrochloric acid to the crude amoxicillin crude product to completely dissolve the amoxicillin, and then filter;

 

4. Crystallization

Under the cooling condition, add 6-10% ammonia concentration to the solution of amoxicillin, control the pH of the liquid to 4.8-5.2, and grow the crystal for 90-120min under the cooling condition;

 

5.Suction filtration, washing and drying

Use the crystallization filter washing and drying multifunctional all-in-one machine to filter the amoxicillin crystal liquid, wash it with purified water and acetone, and then dry the amoxicillin wet powder under vacuum and low temperature, the temperature is 40~60℃, the degree of vacuum≥ 0.085MPa, after the end of drying, amoxicillin dry powder was obtained.


Keywords: integrated pressure filtration and washing machine, closed filtration and washing machine, filtering, washing and drying three in one, antibiotic amoxicillin refining



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