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Composition comprising pravastatin

A technology of pravastatin sodium and its composition, which is applied in the field of compositions containing pravastatin sodium, and can solve problems such as retention of purity, reduction of pravastatin yield, and unrecorded purity of pravastatin

Inactive Publication Date: 2005-10-12
SANKYO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0034] Indeed, the separation or purification method of pravastatin is described in Example 3 of the publication, but the purity of pravastatin after extraction with ethyl acetate stays at less than 70.3%. Purification is carried out by chromatography with different separation or purification methods, and there is no record at all about the purity of the final obtained pravastatin
While pravastatin has a tendency to separate at its melting point, these cannot be used as methods for isolation or purification
[0047] Even if any of the aforementioned separation or purification methods are repeated to remove the above-mentioned compound (I), the yield of pravastatin decreases on the contrary.
[0048] Furthermore, as described above, even if any separation or purification method known in the past is combined to reduce the above-mentioned compound (I) to an amount of 0.1% or less, it has not become a method suitable for industrial production of pravastatin

Method used

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  • Composition comprising pravastatin
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0162] Example 1 Extraction from culture concentrate with n-butyl acetate

[0163] (1a) Concentration of culture solution

[0164] After adjusting 10 L of the pravastatin culture solution after transformation culture to pH 12 with sodium hydroxide, it was heated to 50° C. and stirred for 30 minutes. After the culture solution was cooled to room temperature, 500 g of Celite 545 (trademark) (manufactured by CELITE CORPORATION) was added as a filter aid and filtered. 3 L of water was added to the separated bacterial cells, suspended again, and then filtered. The obtained two concentrates were combined to obtain 10 L of culture concentrate.

[0165] (1b) Extraction with n-butyl acetate

[0166] After adjusting the resulting culture concentrate to pH 5.7 with 25% sulfuric acid, 5 L of n-butyl acetate was added and stirred to extract pravastatin. The separated aqueous layer was adjusted to pH 5.7 with 75% sulfuric acid, then 5 L of n-butyl acetate was added, and stirred for ext...

Embodiment 2

[0167] Example 2 Extraction from Culture Concentrate with n-Propyl Acetate

[0168] N-propyl acetate was used to replace n-butyl acetate, and the same treatment as in Example 1 was carried out to obtain an aqueous sodium salt solution of pravastatin. As determined by HPLC (condition A), the purity of pravastatin sodium was 85% or above. As can be seen from the results of this example, high-purity pravastatin sodium can be obtained by using n-propyl acetate.

Embodiment 3

[0169] Embodiment 3 carries out the decomposition of impurity with phosphoric acid

[0170] Add 350 ml of ethanol to the aqueous solution obtained in Example 1 [compound (I) / pravastatin sodium measured by HPLC (condition A) is 9.3%], adjust it to pH 3.0 with phosphoric acid, then stir at 50° C. for 10 minutes . Compound (I) / pravastatin sodium determined by HPLC (condition A) was 0.9%. From the results of this example, it was found that compound (I) can be significantly removed by using phosphoric acid.

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Abstract

A method of isolating or purifying pravastatin or its pharmaceutically acceptable salt characterized by involving, in the process of isolating or purifying pravastatin or its pharmacologically acceptable salt, the step of extracting pravastatin using an organic solvent represented by the formula CH3CO2R (wherein R represents an alkyl group having 3 or more carbon atoms) or the step of decomposing impurities using an inorganic acid or an inorganic base; and compositions containing pravastatin sodium thus obtained.

Description

[0001] This application is an invention patent application with the PCT application number PCT / JP01 / 09045 (the application number entering the national phase is 01820712.X), the application date is October 15, 2001, and the invention name is "method for purifying pravastatin" divisional application. technical field [0002] The present invention relates to the separation or purification method of pravastatin or its pharmaceutically acceptable salt, which is characterized in that in the process of separating or purifying pravastatin or its pharmaceutically acceptable salt, the method with formula CH 3 CO 2 The step of extracting pravastatins with an organic solvent of R (in the formula, R represents an alkyl group with a carbon number equal to or greater than 3); it involves the step of decomposing impurities with an inorganic acid or a pharmaceutically acceptable pravastatin A method for isolating or purifying salts of pravastatin or a pharmaceutically acceptable salt thereof...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C67/48C07C67/58C07C67/60C07C67/62C07C69/33C12P7/62C12P7/64C12P17/06
CPCC12P7/62C07C67/58C12P17/06C07C2102/28C07C69/33C07B2200/07C07C67/60C07C2602/28A61P3/06C07C67/48
Inventor 杉尾伸弼高松安行小岛俊氏铃木睦夫萩泽稔浜野洁
Owner SANKYO CO LTD
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