Sodium pantothenate compound, and composition preparation containing it

A technology of sodium pantothenate and compound, applied in the field of sodium pantothenate compound and composition preparation containing the compound, can solve the problems of inability to guarantee the stability of the preparation, the crystal quality is not stable enough, the preparation process is unstable, etc. Medication safety and stable effect

Active Publication Date: 2014-12-17
SHANXI PUDE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the process of practical application, it was found that the preparation process of the above-mentioned hydrate is not stable, the reproducibility is not strong, and it is difficult to popularize and apply
In addition, during the freeze-drying process, the water molecules in the ab...

Method used

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  • Sodium pantothenate compound, and composition preparation containing it
  • Sodium pantothenate compound, and composition preparation containing it
  • Sodium pantothenate compound, and composition preparation containing it

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The preparation of embodiment 1 sodium pantothenate compound

[0044] (1) Take the commercially available crude sodium pantothenate, add water equivalent to 40 times the weight of the crude sodium pantothenate, stir and dissolve at 50°C, and concentrate under reduced pressure to 1 / 5 of the original volume; wherein, concentrate under reduced pressure under vacuum at 60 Below ℃, the vacuum degree is 0.07 MPa;

[0045] (2) Add activated carbon 0.08 times the weight of crude sodium pantothenate to the solution for decolorization, and filter;

[0046] (3) Stir and add ethanol:ether mixed solution whose volume is 1 / 4 of the solution to the filtrate; the volume of ethanol and ether in the ethanol:ether mixed solution is 1:8. The speed of / min cools the filtrate to 12°C; wherein, the stirring speed is 8rmp;

[0047] (4) Stop stirring, cool the solution down to 2°C at a uniform speed within 30 minutes, and place it under an ultrasonic field to grow crystals for 8 hours, the ul...

Embodiment 2

[0049] The preparation of embodiment 2 sodium pantothenate compound

[0050] (1) Take the commercially available crude sodium pantothenate, add water equivalent to 30 times the weight of the crude sodium pantothenate, stir and dissolve at 45°C, and concentrate under reduced pressure to 1 / 4 of the original volume; wherein, concentrate under reduced pressure under vacuum at 60 Below ℃, the vacuum degree is 0.06 MPa;

[0051] (2) Add activated carbon 0.05 times the weight of crude sodium pantothenate to the solution for decolorization, and filter;

[0052] (3) Stir and add ethanol:ether mixed solution whose volume is 1 / 5 of the solution to the filtrate; the volume of ethanol and ether in the ethanol:ether mixed solution is 1:5. The speed of / min cools the filtrate to 10°C; wherein, the stirring speed is 6rmp;

[0053] (4) Stop stirring, cool the solution down to 0°C within 20 minutes, and place it in an ultrasonic field to grow crystals for 6 hours, the ultrasonic frequency is ...

Embodiment 3

[0054] The preparation of embodiment 3 sodium pantothenate compound

[0055] (1) Take the commercially available crude sodium pantothenate, add water equivalent to 45 times the weight of the crude sodium pantothenate, stir and dissolve at 55°C, and concentrate under reduced pressure to 1 / 6 of the original volume; wherein, concentrate under reduced pressure under vacuum at 60 Below ℃, the vacuum degree is 0.08 MPa;

[0056] (2) Add activated carbon 0.1 times the weight of the crude product of sodium pantothenate to the solution for decolorization, and filter;

[0057] (3) Stir and add ethanol:ether mixed solution whose volume is 1 / 3 of the solution to the filtrate; the volume of ethanol and ether in the ethanol:ether mixed solution is 1:12 while feeding at 2.5°C / The speed of min will cool the filtrate to 15°C; wherein, the stirring speed is 12rmp;

[0058] (4) Stop stirring, cool the solution down to 5°C within 40 minutes, and place it under an ultrasonic field to grow cryst...

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Abstract

The invention discloses a sodium pantothenate compound. Sodium pantothenate is determined through a powder X-ray diffraction assay method, and characteristic diffraction peaks of an X-ray powder diffraction pattern appear at 2theta+/-0.2DEG diffraction angles of 6.02DEG, 9.08DEG, 9.92DEG, 12.16DEG, 12.63DEG, 13.01DEG, 14.93DEG, 18.95DEG, 20.20DEG, 20.96DEG, 22.81DEG, 23.40DEG, 24.16DEG, 26.41DEG, 29.39DEG, 32.11DEG, 33.93DEG, 37.28DEG and 40.72DEG. The sodium pantothenate compound and its preparation have substantially better advantages than present sodium pantothenate compounds in stability tests. The sodium pantothenate compound disclosed in the invention can substantially improve the stability of the preparation, so the medicine safety of patients can be guaranteed.

Description

technical field [0001] The invention relates to a sodium pantothenate compound, in particular to a sodium pantothenate compound and a composition preparation containing the compound. Background technique [0002] Sodium pantothenate (CAS No.: 867-81-2) is a white crystal or crystalline powder, used for various diseases that require vitamin supplementation, supplementing the nutrients necessary to maintain the normal physiological metabolism of the human body. Commonly used in medicine, food and cosmetics, such as injection of water-soluble vitamins. The vitamins are micronutrients necessary to maintain the normal metabolic function of the human body, and mainly act on the energy transfer and metabolic regulation of the body. Enzymes are critical and are necessary for drug metabolism, capture of free radicals, protection from cell damage and peroxidation of cell membranes. Since it cannot be synthesized in the human body or the amount of synthesis is very small, it must be ...

Claims

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Application Information

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IPC IPC(8): C07C235/12C07C231/24A61K31/197A61K9/19A61K31/675A61P3/02
Inventor 王勇李立忠解晓荣李润宝昝建强姚荷云武晋胡成伟
Owner SHANXI PUDE PHARMA CO LTD
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