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Calcifediol and vitamin D3 eutectic crystal, preparation method and applications 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.

Active Publication Date: 2019-08-16
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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  • Calcifediol and vitamin D3 eutectic crystal, preparation method and applications thereof
  • Calcifediol and vitamin D3 eutectic crystal, preparation method and applications thereof
  • Calcifediol and vitamin D3 eutectic crystal, preparation method and applications thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Calcidiol and Vitamin D 3 eutectic

[0063] At room temperature, weigh calcifediol (20.32g) and vitamin D 3 (19.23 g) powder, completely dissolved in 2.5 L of acetonitrile solution to form calcifediol and vitamin D 3 unsaturated solution. Cool this unsaturated solution from room temperature to -20 degrees Celsius, and after standing for 24 hours, there will be calcifediol and vitamin D 3 The eutectic powder precipitated out. The suspension is centrifuged and filtered to obtain calcifediol and vitamin D 3 (31.35 g).

[0064] calcifediol and vitamin D 3 The co-crystals were characterized by X-ray powder diffraction (XRPD), X-ray single crystal diffraction (SC-XRD), thermogravimetric analysis (TG), differential scanning calorimetry (DSC) and infrared (IR) spectroscopy .

[0065] The results of X-ray powder diffraction pattern analysis are shown in the appendix figure 1 , X-ray single crystal diffraction analysis results are shown in the attached figure 2 , the r...

Embodiment 2

[0067] At room temperature, weigh calcifediol (30.48g) and vitamin D 3 (28.85 g) powder, completely dissolved in 3.8 L of acetonitrile solution to form calcifediol and vitamin D 3 unsaturated solution. Cool this unsaturated solution from room temperature to -20 degrees Celsius, and after standing for 24 hours, there will be calcifediol and vitamin D 3 The eutectic powder precipitated out. The suspension is centrifuged and filtered to obtain calcifediol and vitamin D 3 (47.46 g).

Embodiment 3

[0069] At room temperature, weigh calcifediol (16.26g) and vitamin D respectively 3 (15.38 g) powder, completely dissolved in 3 L of acetonitrile solution to form calcifediol and vitamin D 3 unsaturated solution. Place the unsaturated solution at room temperature to continuously volatilize and concentrate to precipitate crystals, thereby obtaining calcifediol and vitamin D 3 eutectic. Centrifugal filtration to obtain calcifediol and vitamin D 3 (24.63 g).

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Abstract

The invention relates to a calcifediol and vitamin D3 eutectic crystal, a preparation method and applications thereof, wherein a molar ratio of calcifediol to vitamin D3 in the eutectic crystal is 1:1, and the complete characterizing results of the calcifediol and vitamin D3 eutectic crystal by X-ray single crystal diffraction, X-ray powder diffraction, thermogravimetric analysis, differential thermal analysis, infrared spectral analysis and other methods show that the calcifediol and vitamin D3 eutectic crystal can significantly improve the chemical stability under illumination conditions; and the preparation method is simple, and can achieve repeated preparation.

Description

technical field [0001] The invention relates to the technical field of medicinal chemistry and crystallization technology, in particular to calcifediol and vitamin D 3 The eutectic and its preparation method and application. Background technique [0002] When two or more drugs are used in combination in clinical practice, in order to improve compliance, they are generally chosen to be developed into compound prescriptions. However, due to the physical mixing of two or more active pharmaceutical ingredients (APIs) in compound drugs, it brings many difficulties: (a) The quality control standard of APIs. Although two or more APIs of the compound drug are mixed in a certain proportion, the reproducibility of the content standard is poor; because of the physical mixing, the X-ray powder diffraction responses of different compounds are different, and it is impossible to establish Crystal form standard. (b) Dispersion of APIs during formulation. The APIs contained in each unit ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
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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