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Folic acid freeze-dried injection and preparation thereof

A technology for freeze-dried powder injections and powder injections, which is applied in the field of folic acid freeze-dried powder injections and its preparation, and can solve problems such as poor water solubility, poor resolubility of powder injections, and turbidity

Active Publication Date: 2008-08-20
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The reason is that it is difficult to make folic acid powder injection. Due to its poor water solubility, the solubility is only 1.6mg / L (25°C). Disadvantages such as turbidity

Method used

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  • Folic acid freeze-dried injection and preparation thereof
  • Folic acid freeze-dried injection and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Folic acid 15g, mannitol 100g, mix appropriate amount of water for injection, folic acid and mannitol, and stir until it becomes a paste; slowly add 4% sodium bicarbonate solution to dissolve it all, and make the pH value at 6.5, then stir for 20 minutes After the pH remains unchanged, add water for injection to 2000ml, then coarsely filter with activated carbon with a concentration of 0.005mg / ml, and then pass through 1.0um, 0.45um, 0.22um microporous membranes to sterilize and filter, and then filter into the sterile room. Measure the pH value and folic acid content of the solution. After passing the test, fill it, press half the plug, put it into a freeze-drying box that has been cooled to -50°C, and pre-freeze for 100 minutes.

[0058] After the drug is frozen, start the vacuum machine to evacuate to 10Pa, turn off the freezer, heat the drug to make the temperature of the frozen product rise to -25°C; the time is 20 hours and 20 minutes, then gradually heat the drug ...

Embodiment 2

[0060] Folic acid 30g, mannitol 100g, mix appropriate amount of water for injection, folic acid and mannitol, and stir until it becomes a paste; slowly add 4% sodium bicarbonate solution to dissolve it all, and make the pH value at 8.5, then stir for 20 minutes After the pH remains unchanged, add water for injection to 2000ml, then coarsely filter with activated carbon with a concentration of 0.005mg / ml, and then pass through 1.0um, 0.45um, 0.22um microporous membranes to sterilize and filter, and then filter into the sterile room. Measure the pH value and folic acid content of the solution. After passing the test, fill it, press half the plug, put it into a freeze-drying box that has been cooled to -50°C, and pre-freeze for 100 minutes.

[0061] After the drug is frozen, start the vacuum machine to evacuate to 10Pa, turn off the freezer, heat the drug to make the temperature of the frozen product rise to -25°C; the time is 20 hours and 20 minutes, then gradually heat the drug ...

Embodiment 3

[0063] Folic acid 40g, mannitol 200g, mix appropriate amount of water for injection, folic acid and mannitol, and stir until it becomes a paste; slowly add 4% sodium bicarbonate solution to dissolve it all, and make the pH value at 7.0, then stir for 20 minutes After the pH remains unchanged, add water for injection to 2000ml, then use activated carbon with a concentration of 0.005mg / ml for coarse filtration, then; room, measure the pH value and folic acid content of the solution, after passing the test, fill it, press half the plug, put it into a freeze-drying box that has been cooled to -50°C, and pre-freeze for 100 minutes.

[0064] After the drug is frozen, start the vacuum machine to evacuate to 10Pa, turn off the freezer, heat the drug to make the temperature of the frozen product rise to -25°C; the time is 20 hours and 20 minutes, then gradually heat the drug to 0°C, and keep it vacuum-dried for 10 hours. Continue to heat up to 25°C and vacuum-dry for 3 hours, press the...

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Abstract

The invention provides a folic acid lyophiled powder injection and a preparation method, comprising folic acid and mannitol, which is characterized in that the weight ratio of the folic acid and the mannitol is 1:2.5 to 10. The preparation method has the advantages of simple prescription, little side effect, and plump appearance, good double solubility and fine quality for the prepared product due to the adoption of the advanced freeze drying craft.

Description

technical field [0001] The invention relates to a folic acid freeze-dried powder injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Folic acid is a water-soluble B vitamin that is abundantly stored in green leafy vegetables, fruits and animal livers. Folic acid participates in the whole process of human metabolism. It is an indispensable substance for the production of red blood cells and helps protein metabolism. Folic acid is also an essential vitamin for the synthesis of DNA, an important substance in the human body, and plays an important role in the production of nucleic acids (DNA, RNA). It is an indispensable substance in cell proliferation, and it can also promote milk secretion and prevent anemia. Its lack can not only lead to fetal neural tube defects, but also increase the deformity rate of eyes, lips, palate, gastrointestinal tract, cardiovascular, kidney, bones and other organs. Acco...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/519A61K47/10A61P3/02
Inventor 刘保起李明华张世伟
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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