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Method for preparing amorphous atorvastatin calcium

A technology of atorvastatin calcium and amorphous form, which is applied in the field of preparation of chemical agents, can solve the problems of low yield, increased production cost, unfavorable requirements for solvent recovery and mechanical application, etc., and achieves high yield and simple method Effect

Inactive Publication Date: 2010-02-10
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage of this method is that the yield is low, and the remaining filtrate after filtration contains atorvastatin calcium, which is not conducive to the requirements for solvent recovery in industrial production and increases production costs.

Method used

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  • Method for preparing amorphous atorvastatin calcium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Dissolve 1 g of atorvastatin calcium in 20 mL of methanol to obtain a clear and transparent solution. The solvent was evaporated to dryness at 45° C. under a pressure of about 100 Torr to obtain a foamy solid. The bubbly solid was washed with 5 mL of water, filtered, and the solid was evaporated to dryness under the same reduced pressure to obtain 0.98 g of amorphous atorvastatin calcium, with a yield of 98.0%.

Embodiment 2

[0018] Add 5 g of atorvastatin calcium to 40 mL of methanol, stir and heat to 40 °C until a clear and transparent solution is obtained. The solvent was evaporated to dryness at 15° C. under a pressure of about 5 Torr to obtain a foamy solid. The bubbly solid was air-dried at 50° C. for 1 hour to obtain 4.90 g of amorphous atorvastatin calcium with a yield of 98.0%.

Embodiment 3

[0020] Add 2 g of atorvastatin calcium to 20 mL of ethanol, stir and heat to 35 °C to obtain a transparent solution. The solvent was evaporated to dryness at 70 degrees Celsius under a pressure of about 200 Torr to obtain a white solid. The solid was washed with 5 mL of acetone, and the solid was air-dried at 50 degrees Celsius for 1 hour to obtain 1.95 g of amorphous atorvastatin calcium, with a yield of 97.5%.

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Abstract

The invention belongs to the technical field of chemical agent preparations, and particularly discloses a method for preparing amorphous atorvastatin calcium. The method comprises the following steps:a, dissolving atorvastatin calcium with any crystal form into a hydroxylic solvent; and b, removing the solvent to obtain the amorphous atorvastatin calcium. Compared with the prior method for preparing the amorphous atorvastatin calcium, the method is simpler, has higher yield and is more suitable for production.

Description

Technical field: [0001] The invention belongs to the technical field of preparation of chemical medicaments, in particular to a preparation method of amorphous atorvastatin calcium. Background technique: [0002] Atorvastatin calcium is a synthetic HMG-CoA reductase inhibitor used to treat hyperlipidemia and hypercholesterolemia. In the prior art, four different crystalline forms of atorvastatin calcium are disclosed. WO97 / 03958 discloses crystalline form III of atorvastatin calcium; WO97 / 03959 discloses crystalline forms I, II and IV of atorvastatin calcium. The amorphous form of atorvastatin calcium has numerous advantages over the crystalline form in that it has variable solubility properties and, in some cases, variable bioavailability. In certain instances, certain bioavailability characteristics are preferred over crystalline atorvastatin calcium. For this reason, there is a need for a process capable of preparing amorphous atorvastatin calcium. [0003] WO97 / 03960...

Claims

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Application Information

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IPC IPC(8): C07D207/34A61P3/06
Inventor 林学军陈燕桂刘远涛赵焕臣贲绍业卢轩
Owner SUNSHINE LAKE PHARM CO LTD
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