Pravastatin sodium compound and novel preparation method thereof

A technology of pravastatin sodium and pravastatin is applied in the preparation of organic compounds, chemical instruments and methods, organic chemistry and other directions, and can solve the problems of low purity of pravastatin sodium compounds and the like

Inactive Publication Date: 2011-05-25
HAINAN MEIDA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] In order to overcome the defects of the above-mentioned prior art, especially the defect of low purity of the pravastatin sodium compound prepared by the prior art, the invention provides a new method for preparing pravastatin sodium, which is refined by pravastatin sodium , obtain high-purity pravastatin sodium with high yield, improve the product quality of preparations, reduce toxic and side effects, and ensure the safety of clinical medication

Method used

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  • Pravastatin sodium compound and novel preparation method thereof
  • Pravastatin sodium compound and novel preparation method thereof
  • Pravastatin sodium compound and novel preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] The refining of embodiment 1 pravastatin sodium

[0056] 10 g of crude pravastatin sodium (purity 98.4%) was dissolved in 200 ml of water, added into a fixed bed filled with D001 type strongly acidic styrene-based cation exchange resin, and continued to exchange for 1.5 hours.

[0057] Elution was carried out with 1% aqueous sodium bicarbonate solution at an elution rate of 1.0 ml / min, the eluate was collected, and the eluate was filtered to obtain the elution mother liquor.

[0058] The eluting mother liquor is passed through the chromatographic column, and the packing agent as the stationary phase is fine-pore silica gel with a particle diameter of 80-200 μm and a pore diameter of 40-80A. The length of the column is 20 cm, and the diameter is 3 cm. : 1) Carry out column chromatography, flow rate is 2.5ml / min, column temperature keeps 30 ℃, start timing, take a sample, track and monitor, carry out segmental collection, collect liquid, wash with water, dry over anhydr...

Embodiment 2

[0059] The refining of embodiment 2 pravastatin sodium

[0060] 10 g of pravastatin sodium crude product (purity 98.2%) was dissolved in 200 ml of water, added to a fixed bed filled with D001 type strongly acidic styrene-based cation exchange resin, and continued to exchange for 1.5 hours.

[0061] Elute with 0.5% aqueous sodium bicarbonate solution at an elution rate of 0.8 ml / min, collect the eluate, and filter the eluate to obtain the eluted mother liquor.

[0062] The eluting mother liquor is passed through the chromatographic column, and the packing agent as the stationary phase is fine-pore silica gel with a particle diameter of 80-200 μm and a pore diameter of 40-80A. The length of the column is 20 cm, and the diameter is 3 cm. 0.85:1) for column chromatography, the flow rate is 2.0ml / min, the column temperature is kept at 30°C, start timing, sampling, follow-up monitoring, segmental collection, collect the liquid, wash with water, dry over anhydrous sodium sulfate, a...

Embodiment 3

[0063] The refining of embodiment 3 pravastatin sodium

[0064] 20g of crude pravastatin sodium (purity 97.9%) was dissolved in 200ml of water, added into a fixed bed filled with D001 type strongly acidic styrene-based cation exchange resin, and continued to exchange for 1.5 hours.

[0065] Elute with 0.2% sodium carbonate aqueous solution at an elution rate of 1.2 ml / min, collect the eluate, filter the eluate, and obtain the eluted mother liquor.

[0066] The eluting mother liquor is passed through the chromatographic column, and the filler as the stationary phase is fine-pore silica gel with a particle diameter of 80-200 μm and a pore diameter of 40-80A. The length of the column is 20 cm, and the diameter is 3 cm. : 1) Carry out column chromatography, flow velocity is 0.5ml / min, column temperature keeps 30 ℃, start timing, take a sample, track and monitor, carry out segmental collection, collect liquid, wash with water, dry over anhydrous sodium sulfate, concentrate under ...

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Abstract

The invention provides a pravastatin sodium compound and a novel preparation method thereof. The method comprises the following steps of: (1) performing absorption and ion exchange on pravastatin sodium by using strongly acidic ion exchange resin; (2) eluting by using sodium carbonate or sodium bicarbonate aqueous solution at the concentration of 0.1 to 2 percent; and (3) separating and purifying the elution mother liquor by using a chromatographic column, collecting the eluted solution, washing by using water, drying by using a solid drying agent, concentrating under reduced pressure, evaporating to remove the eluted solution and obtaining a pravastatin sodium pure product. According to the high-purity pravastatin sodium compound prepared by the refining method, the purity and the content of the pravastatin sodium are increased greatly, the product quality of the preparation is improved, the toxic and side effects are reduced and the clinic medication safety is ensured; the method is simple in technology, low in cost and high in yield rate and is suitable for industrial production.

Description

technical field [0001] The invention relates to a compound and a new preparation method thereof, in particular to a new preparation method of pravastatin sodium compound, which belongs to the technical field of medicine. Background technique [0002] Pravastatin Sodium, chemical name: {1S-[1a(bs*, ds*), 2a, 6a, 8b(R*), 8aa]}-1, 2, 6, 7, 8, 8a-Hexahydro-b,d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-1-naphthoheptanoic acid monosodium salt, molecular formula: C 23 h 35 NaO 7 , molecular weight: 446.52, chemical structural formula [0003] [0004] This product is a lipid-lowering drug isolated from fungal culture fluid. Its functions are as follows: ①Inhibit the rate-limiting enzyme methylhydroxyglutaryl-CoA reductase in the cholesterol synthase system to reduce cholesterol synthesis. ②Increase the synthesis of low-density lipoprotein receptors on the surface of liver cells, increase the clearance of low-density lipoprotein and cholesterol. ③Increase the synthesis ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C69/22C07C67/56
Inventor 廖爱国
Owner HAINAN MEIDA PHARMA
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