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Eutectic crystal of calcifediol and vitamin D3 as well as preparation method and application thereof

A technology of calcifediol and vitamin, which is applied in the field of co-crystal and preparation of calcifediol and vitamin D3, can solve the problems of poor patient compliance, difficulty in rationally matching use of vitamin D calcifediol, etc.

Inactive Publication Date: 2018-06-08
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, vitamin D of various specifications in use 3 It is difficult to reasonably match with calcifediol, and the patient's compliance is poor

Method used

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  • Eutectic crystal of calcifediol and vitamin D3 as well as preparation method and application thereof
  • Eutectic crystal of calcifediol and vitamin D3 as well as preparation method and application thereof
  • Eutectic crystal of calcifediol and vitamin D3 as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Calcidiol and Vitamin D 3 Eutectic

[0057] At room temperature, weigh calcidiol (20.32g) and vitamin D 3 (19.23g) powder, completely dissolved in 500mL acetonitrile solution to form calcidiol and vitamin D 3 The unsaturated solution. Cool this unsaturated solution from room temperature to -20 degrees Celsius. After standing for 24 hours, there will be calcifediol and vitamin D. 3 The eutectic powder precipitated. Centrifuge and filter the suspension to obtain calcidiol and vitamin D 3 The eutectic (31.35g).

[0058] For the prepared calcidiol and vitamin D 3 The eutectic is characterized by X-ray powder diffraction (XRPD), X-ray single crystal diffraction (S-CXRD), thermogravimetric analysis (TG), differential scanning calorimetry (DSC) and infrared (IR) spectroscopy .

[0059] The X-ray powder diffraction pattern analysis results are attached figure 1 , See attached for X-ray single crystal diffraction analysis results figure 2 , See the results of thermogravimetric analy...

Embodiment 2

[0061] At room temperature, weigh calcidiol (30.48g) and vitamin D 3 (28.85g) powder, completely dissolved in 700mL acetonitrile solution to form calcidiol and vitamin D 3 The unsaturated solution. Cool this unsaturated solution from room temperature to -20 degrees Celsius. After standing for 24 hours, there will be calcifediol and vitamin D. 3 The eutectic powder precipitated. Centrifuge and filter the suspension to obtain calcidiol and vitamin D 3 The eutectic (47.46g).

Embodiment 3

[0063] At room temperature, weigh calcidiol (16.26g) and vitamin D 3 (15.38g) powder, completely dissolved in 300mL acetonitrile solution to form calcidiol and vitamin D 3 The unsaturated solution. Place this unsaturated solution at room temperature and continuously volatilize and concentrate to precipitate crystals, thereby obtaining calcidiol and vitamin D 3 The eutectic. Centrifugal filtration to obtain calcidiol and vitamin D 3 The eutectic (24.63g).

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Abstract

The invention relates to a eutectic crystal of calcifediol and vitamin D3 as well as a preparation method and application thereof. In the eutectic crystal, the mole ratio of the calcifediol to the vitamin D3 is 1 to 1. The eutectic crystal of the calcifediol and the vitamin D3 is subjected to comprehensive characterization by applying measures such as X-ray single crystal diffraction, X-ray powderdiffraction, thermogravimetric analysis, differential scanning calorimetry and infrared spectroscopic analysis, thereby finding that the chemical stability of the vitamin D3 of the eutectic crystal can be obviously improved under an illumination condition. The preparation method of the eutectic crystal of the calcifediol and the vitamin D3 is simple, and the eutectic crystal can be repeatedly prepared.

Description

Technical field [0001] The invention relates to the technical field of medicinal chemistry and crystallization technology, in particular to calcidiol and vitamin D 3 Co-crystal and its preparation method and application. Background technique [0002] When two or more drugs are used in combination in the clinic, they generally choose to develop a compound prescription in order to improve compliance. However, because two or more active pharmaceutical ingredients (APIs) in compound drugs are physically mixed, it brings many problems: (a) The quality control standard of APIs. Although two or more APIs of compound drugs are mixed in a certain proportion, the reproducibility of their content standards is poor; because they are physically mixed, the X-ray powder diffraction response of different compounds is different, and it is impossible to establish Crystal standard. (b) The dispersion of APIs during the formulation process. The APIs contained in each unit dose of pharmaceutical p...

Claims

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Application Information

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IPC IPC(8): C07C401/00A61K31/593A61P19/08A61P13/12A61P5/16A61P3/02
CPCC07B2200/13C07C401/00A61P3/02A61P5/16A61P13/12A61P19/08
Inventor 梅雪锋王建荣余琦慧鲍俊杰方靖
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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