Betamethasone phosphate dihydrate as well as preparation method and application thereof

A technology of metasone phosphate and dihydrate, which is applied in the field of medicine, can solve the problems of poor crystallinity and unfavorable production, and achieve the effects of good crystallinity, industrialization and simple operation

Pending Publication Date: 2022-07-01
TIANJIN PHARMA GROUP CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The betamethasone phosphate obtained by the method reported in the above-mentioned documents is determined by X-ray powder diffraction, and it is anhydrous, and its crystallinity is poor, and a certain amount of impurities are easily trapped, which is not conducive to participating in the production of downstream products as high-quality raw materials

Method used

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  • Betamethasone phosphate dihydrate as well as preparation method and application thereof
  • Betamethasone phosphate dihydrate as well as preparation method and application thereof
  • Betamethasone phosphate dihydrate as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] The preparation of embodiment 1 betamethasone phosphate single crystal

Embodiment 1-1

[0055] Add 1.0g crude betamethasone phosphate to a mixed solvent of methanol (13.3mL) and purified water (6.7mL), heat to 55°C to dissolve, filter the solution into a vial with a 0.45um filter membrane, and seal with plastic wrap Then, pierce a small hole, let it stand at room temperature to volatilize, and grow crystals of suitable size.

[0056] The obtained crystal was analyzed by single crystal X-ray diffraction (SXRD) to obtain the three-dimensional structure of the molecule as follows: figure 1 shown; the molecular packing diagram of the unit cell is shown in figure 2 shown. The single crystal belongs to the orthorhombic system with space group P2 1 2 1 2 1 ,Cell parameters: α=90°, β=90°, γ=90°, unit cell volume The number of molecules in the unit cell is Z=4, and one molecule is contained in an independent region of the unit cell.

[0057] PXRD was obtained by single crystal data simulation, and the characteristic peak positions were measured as 2θ=11.5°±0.2...

Embodiment 1-2

[0059] Add 1.0g crude betamethasone phosphate to a mixed solvent of acetone (2.5mL) and purified water (2.5mL), heat to 50°C to dissolve, filter the solution into a vial with a 0.45um filter membrane, and seal with plastic wrap Then, pierce a small hole, let it stand at room temperature to volatilize, and grow crystals of suitable size.

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Abstract

The invention provides a betamethasone phosphate dihydrate as well as a preparation method and application thereof, and relates to the technical field of medicines. The betamethasone phosphate dihydrate single crystal belongs to an orthorhombic system, the space group is P212121, the cell parameters are as follows: alpha = 90 degrees, beta = 90 degrees, gamma = 90 degrees, the number Z of molecules in the cell volume and the cell is 4, and one molecule is contained in an independent region of a unit lattice. Compared with betamethasone phosphate anhydrate, the brand-new betamethasone phosphate dihydrate provided by the invention is good in crystallinity and high in purity, solves the problem of difficulty in product purification in subsequent procedures, can be used as a high-quality raw material of a betamethasone sodium phosphate preparation, and is beneficial to improvement of the quality of the betamethasone sodium phosphate preparation.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a betamethasone phosphate dihydrate and a preparation method and application thereof. Background technique [0002] Betamethasone phosphate, English name: Betamethasone phosphate, its structural formula is as follows: [0003] [0004] Betamethasone phosphate is an important raw material for the preparation of betamethasone series drugs. The betamethasone sodium phosphate obtained after its salt formation has pharmacological effects such as anti-inflammatory, anti-allergic, immunosuppressive, stress-enhancing, anti-toxin and anti-shock; It is available in a fast-acting injectable form. [0005] The state has higher quality requirements for the preparation of such pharmaceutical preparations. For example, for betamethasone sodium phosphate, the 2015 edition of the Chinese Pharmacopoeia not only stipulates the limits of related substances (single impurity content is not more ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07J51/00
CPCC07J51/00C07B2200/13
Inventor 霍文阁郭会敏
Owner TIANJIN PHARMA GROUP CORP
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