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Dexamethasone palmitate compound and preparation method thereof

A technology of dexamethasone palmitate and compound, applied in the field of dexamethasone palmitate compound and preparation method thereof, can solve the problems of low purity of dexamethasone palmitate and the like

Inactive Publication Date: 2012-11-21
HAINAN YONGTIAN PHARMA INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] In order to overcome the defect of low purity of dexamethasone palmitate prepared by the prior art, the present invention provides a method for refining dexamethasone palmitate, which is separated and purified by activated carbon adsorption, crystallization and macroporous resin adsorption to achieve the refined purification. Purpose, finally get high-purity dexamethasone palmitate

Method used

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  • Dexamethasone palmitate compound and preparation method thereof
  • Dexamethasone palmitate compound and preparation method thereof

Examples

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Effect test

Embodiment 1

[0036] (1) 10 g of dexamethasone palmitate crude product with a purity of 95.6% was dissolved in 50 ml of isopropanol, 0.10 g of gac was added, stirred at 40° C. for 15 min, filtered for decarburization, and the filtrate was collected;

[0037] (2) Cool the above-mentioned filtrate to room temperature, slowly add purified water, stir to produce a precipitate, let it stand for 1 hour to crystallize, and collect the precipitate by filtration;

[0038] (3) Dissolve the above precipitate with 20ml 1:1 ethanol / ethyl acetate, then mix well with 40g of pretreated Sepabeads SP825 macroporous adsorption resin to obtain the resin adsorbing dexamethasone palmitate, then add it to Sepabeads SP825 The top of the macroporous adsorption resin column was washed with 1 to 2 column volumes of purified water until clarified, then eluted with about 1 column volume of 10% ethanol, and finally eluted with 40% isopropanol eluent. The isopropanol fraction eluted with dexamethasone palmitate was conce...

Embodiment 2

[0044] (1) 10 g of dexamethasone palmitate crude product with a purity of 94.7% was dissolved in 200 ml of isopropanol, 1 g of gac was added, stirred at 50° C. for 30 min, filtered for decarburization, and the filtrate was collected;

[0045] (2) Cool the above-mentioned filtrate to room temperature, slowly add purified water, stir to produce a precipitate, let it stand for 2 hours to crystallize, and collect the precipitate by filtration;

[0046] (3) above-mentioned precipitation is dissolved with 20ml 1: 1 ethanol / ethyl acetate, then with pretreated Amberlite XAD-1 macroporous adsorption resin 40g, mix thoroughly to obtain the resin of adsorption dexamethasone palmitate, then add to Wash the top of the Amberlite XAD-1 macroporous adsorption resin column with 1-2 column volumes of purified water until clear, then elute with about 1 column volume of 10% ethanol, and finally wash with 40% isopropanol eluent The isopropanol part eluted from dexamethasone palmitate was collected...

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Abstract

The invention discloses a dexamethasone palmitate compound and a new preparation method thereof. The purposes of refining and purification are fulfilled by adsorption of active carbon, crystallization and adsorption and separation of macroporous adsorption resin, high-purity dexamethasone palmitate is finally obtained, the purity and the content of the dexamethasone palmitate are greatly improved, the quality of a preparation product is improved, the toxic or side effect is reduced, and clinical application safety of the dexamethasone palmitate in preparation of medicaments for treating chronic rheumatoid arthritis is ensured; and the method is simple in process, low in cost and high in yield, and is suitable for industrialized production. By the method, the quality of the preparation product is improved, and the toxic or side effect is reduced; and the method is suitable for industrialized large-scale production.

Description

technical field [0001] The invention relates to a dexamethasone palmitate and a preparation method thereof. The high-purity dexamethasone palmitate product can be obtained through the method of the invention, and the invention belongs to the technical field of medicine. Background technique [0002] Dexamethasone palmitate, chemical name 9-fluoro-11β, 17,21-trihydroxy-16a-methylpregna-1,4-diene-3,20-dione-21-palmitic acid Esters, formula C 38 h 59 FO 6 , molecular weight 630.87, structural formula: [0003] [0004] Dexamethasone palmitate is a non-specific steroidal anti-inflammatory drug used in the treatment of chronic rheumatoid arthritis. The drug was launched in 1988. Clinical studies have shown that the drug is highly fat-soluble and is a "targeted" therapeutic agent. Unlike previous steroid drugs, it has a local therapeutic effect despite intravenous administration. [0005] The document GB869511A uses 4,16-pregnadiene-3,11,20-trione as the starting material...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07J5/00A61P29/00A61P19/02
Inventor 陶灵刚
Owner HAINAN YONGTIAN PHARMA INST
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