Process for producing pravastatin on large scale

Abstract

The invention discloses a process for producing pravastatin on a large scale. The process comprises the steps of fermenting, extracting and refining, wherein a plant extracting solution composed of an exocarpium benincasae extracting solution and a water melon peel extracting solution is used in the fermentation process, drug resistance and the conversion capacity of microorganisms to the substrate compactin and the fermentation level of pravastatin are effectively improved, the yield of pravastatin is increased, and in the steps of extracting and refining, the pH value of the solution, types and dosage of organic solvent, extracting time and temperature, cooling operation and crystallization time are controlled strictly to ensure the yield and purity of pravastatin. The process is stable, cost is low, and large-scale industrial production of pravastatin is achieved.

Description

technical field

[0001] The invention relates to the technical field of medicine preparation, in particular to a process for large-scale production of pravastatin. Background technique

[0002] Pravastatin is a 3-hydroxy 3-methylglutaryl-CoA reductase inhibitor, initially used to treat hyperlipidemia and familial hypercholesterolemia, and later the indications continued to expand, it can slow down the development of atherosclerosis, reduce Coronary atherosclerotic lesions and clinical cardiovascular events.

[0003] The production of pravastatin is usually obtained by a two-step fermentation process, although there are also reports or patents (WO99 / 10499, WO2007 / 147827, US6,274,360 and EP1,266,967) describing that the method for one-step fermentation can be used to produce pravastatin, but due to technical For reasons such as complexity and production efficiency, the industrial production of pravastatin is still based on two-step fermentation.

[0004] The two-step fermenta...

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