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Water-soluble vitamin freeze-dried preparation for injection and preparation method thereof

A technology for water-soluble vitamins and freeze-dried preparations, which can be used in freeze-dried delivery, medical preparations containing active ingredients, pharmaceutical formulas, etc. The effect of improving purity and yield, ensuring drug safety, and improving stability

Active Publication Date: 2015-06-17
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 above-mentioned hydrates are prone to loss, and the crystal quality after the loss of water molecules is not stable enough. After the complete loss of crystal water, the same niacinamide and sodium pantothenate will be obtained as the raw materials, so the preparation cannot be guaranteed. stability

Method used

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  • Water-soluble vitamin freeze-dried preparation for injection and preparation method thereof
  • Water-soluble vitamin freeze-dried preparation for injection and preparation method thereof
  • Water-soluble vitamin freeze-dried preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1 Preparation of sodium pantothenate compound

[0043] (1) Take the commercially available crude product of sodium pantothenate, add water equivalent to 40 times the weight of the crude product of sodium pantothenate, stir and dissolve at 50°C, and concentrate under reduced pressure to 1 / 5 of the original volume; among them, concentrate under reduced pressure under vacuum at 60 Below ℃, the vacuum degree is 0.07 MPa;

[0044] (2) Add activated carbon 0.08 times the weight of crude sodium pantothenate to the solution for decolorization, and filter;

[0045] (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;

[0046] (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 crystal...

Embodiment 2

[0048] Embodiment 2 Preparation of sodium pantothenate compound

[0049] (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;

[0050] (2) Add activated carbon 0.05 times the weight of crude sodium pantothenate to the solution for decolorization, and filter;

[0051] (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;

[0052] (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 0.1K...

Embodiment 3

[0053] Embodiment 3 Preparation of sodium pantothenate compound

[0054] (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;

[0055] (2) Add activated carbon 0.1 times the weight of the crude product of sodium pantothenate to the solution for decolorization, and filter;

[0056] (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;

[0057] (4) Stop stirring, cool the solution down to 5°C within 40 minutes, and place it under an ultrasonic field to grow crystals ...

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Abstract

The invention discloses a water-soluble vitamin freeze-dried preparation for injection. 1000 bottles of freeze-dried preparations are prepared from the following raw materials: 2.8-3.4g of thiamine mononitrate, 36-44g of nicotinamide, 4.4-5.4g of pyridoxine hydrochloride, 14.8-18.1g of sodium pantothenate compound, 4.4-5.4g of riboflavin sodium phosphate, 102-124g of sodium ascorbate, 54-66mg of biotin, 0.36-0.44g of folic acid, 4.5-6.0mg of vitamin B12, 0.4-0.6g of methyl p-hydroxybenzoate, 280-320g of glycine, 0.4-0.6g of ethylene diamine tetraacetic acid disodium salt and 2000-3000ml of water for injection. The stability of existing sodium pantothenate is obviously improved by the obtained sodium pantothenate compound, thus ensuring that the sodium pantothenate containing water-soluble vitamin freeze-dried preparation for injection has ideal stability and curative effect and further ensuring medication safety of the patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a freeze-dried preparation of water-soluble vitamins for injection and a preparation method thereof. Background technique [0002] Vitamins are trace nutrients necessary to maintain the normal metabolic function of the human body. They mainly act on the energy transfer and metabolic regulation of the body. It is essential for drug metabolism, capture of free radicals, prevention of 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 obtained from food in a quantitative and regular manner. The imitation injection of water-soluble vitamins is mainly used clinically for the prevention and treatment of water-soluble vitamin deficiency. Freeze-dried powder for injection has good stability, long shelf life, and is easier to store and transport than injection. [0003] Since wa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/714A61K31/525A61K31/519A61K31/51A61K31/455A61K31/4415A61K31/4188A61K31/375A61K31/197A61K9/19A61P3/02C07C235/12C07C231/24
Inventor 王勇李立忠解晓荣李润宝苏志强姚荷云武晋胡成伟
Owner SHANXI PUDE PHARMA CO LTD
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