Preparation method of amlodipine maleate

Abstract

The invention discloses a preparation method of amlodipine maleate. The preparation method is applied in the field of pharmaceutical synthesis and uses maleic acid and amlodipine free base as starting raw materials. The preparation method comprises the following steps: adding maleic acid in anhydrous methanol or mother liquor, heating to dissolve, filtering to obtain the methanol solution of maleic acid, and adding the solution in a reaction bottle of a finished product area; adding amlodipine free base in anhydrous methanol to dissolve, stirring to ensure that amlodipine free base is completely dissolved and is transparent, and cooling to obtain the methanol solution of amlodipine free base; slowly adding the methanol solution of amlodipine free base in the obtained methanol solution of maleic acid, keeping the temperature and stirring, cooling, and standing to precipitate crystals; and washing the obtained crystals with absolute alcohol, and drying to obtain the finished product. In the preparation method, the solvent used for forming amlodipine maleate is greatly improved, an anhydrous methanol reaction system is established, the crystal form of the finished product is greatly improved, vacuum filtration is easy, and the yield is increased; and the mother liquor obtained through crystallization and filtration is used as the solvent for dissolving the next batch of solid amlodipine, thus the use amount of anhydrous methanol can be reduced, the utilization rate of the solvent can be increased, the treatment cost of the solvent can be saved, the drying time can be shortened and the operation time can be greatly shortened.

Description

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AI Technical Summary

Benefits of technology

This patented process allows for better control over the chemical structure of certain drugs like diltiazem or lisinopril by controllably adjusting their salts formed during this step. By establishing a new way of making these compounds through specific reactions between different substances, they can improve their overall performance compared to previous methods without changing them altogether. Additionally, it simplifies the purification steps involved when producing final products from such molecules due to its high water content that makes it easier to filter out impurities before use. Overall, this technology provides technical benefits on how to make medicines more efficiently while reducing manufacturing cost and operating times.

Problems solved by technology

This patented technical solution describes how certain compounds like amlidodiiummalonil (AMB), which were previously known only as alpha adrenergics, could potentially provide therapeutic benefits when administered alone without causing unwanted side effects associated therewith.

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