Folic acid solid dispersion body and preparation method thereof

A technology of solid dispersion and solid preparation, which is applied in the field of medicine to achieve the effects of easy industrial scale-up, good dissolution behavior and good stability

Active Publication Date: 2016-03-16
北京斯利安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In summary, there is currently no effective technical means to provide a more advantageous folic acid drug in clinical practice. Therefore, there is an urgent need to provide a comprehensive advantage of uniform content, good dissolution rate, high bioavailability, and good stability. clinical drugs

Method used

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  • Folic acid solid dispersion body and preparation method thereof
  • Folic acid solid dispersion body and preparation method thereof
  • Folic acid solid dispersion body and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Preparation of folic acid solid dispersion:

[0038] prescription:

[0039] Raw materials

Dosage

folic acid

100g

Poloxamer 188

500g

[0040] Process:

[0041] 1) Weigh the prescribed amount of folic acid and poloxamer 188, first melt the poloxamer 188 completely at 65°C, then add folic acid, and stir until completely melted;

[0042] 2) Rapidly cooling the completely melted folic acid and hydrophilic carrier obtained in 1) in an ice bath and under stirring conditions until they are completely solidified, and then frozen at -15°C for 4 hours;

[0043] 3) Take the material obtained in 2) after freezing, dry it at 35° C. for 2 hours, take it out, crush and sieve the material within the range of 80-150 meshes, and obtain the folic acid solid dispersion.

Embodiment 2

[0045] Preparation of folic acid solid dispersion:

[0046] prescription:

[0047] Raw materials

Dosage

folic acid

100g

polyethylene glycol 6000

1000g

[0048] Process:

[0049] 1) Weigh the prescribed amount of folic acid and polyethylene glycol 6000, first melt the polyethylene glycol 6000 completely at 80°C, then add folic acid, and stir until completely melted;

[0050] 2) Rapidly cooling the completely melted folic acid and the hydrophilic carrier obtained in 1) in an ice bath and stirring until completely solidified, and then freezing at -25°C for 6 hours;

[0051] 3) Take the material obtained in 2) after freezing, dry it at 45°C for 6 hours, take it out, crush and sieve the material within the range of 80-150 meshes, and obtain the folic acid solid dispersion.

Embodiment 3

[0053] Preparation of folic acid solid dispersion:

[0054] prescription:

[0055] Raw materials

Dosage

folic acid

100g

Poloxamer 188

1500g

polyethylene glycol 4000

1500g

[0056] Process:

[0057] 1) Weigh the prescribed amount of folic acid and hydrophilic carrier, first melt the carrier completely at 70°C, then add folic acid, and stir until completely melted;

[0058] 2) Rapidly cooling the completely melted folic acid and hydrophilic carrier obtained in 1) in an ice bath and under stirring until completely solidified, and then freezing at -20°C for 8 hours;

[0059] 3) Take the material obtained in 2) after freezing, dry it at 40°C for 4 hours, take it out, crush and sieve the material within the range of 80-150 meshes, and obtain the folic acid solid dispersion.

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Abstract

The present invention relates to the field of medicines, particularly to a folic acid solid dispersion body and a preparation method thereof, wherein the solid dispersion body comprises a hydrophilic carrier and folic acid, a weight ratio of the folic acid to the hydrophilic carrier is 1:5-1:50, and the hydrophilic carrier is one or a composition comprising one or a plurality of materials selected from poloxamer, polyethylene glycol, povidone and mannitol. According to the present invention, the particle size distribution of the folic acid solid dispersion body is 80-150 mesh; the preparation method is a melting method or a grinding method; the clinical preparation form of the solid dispersion body is an oral solid preparation, and the 30 min dissolution of the oral solid preparation is not less than 90%; and the folic acid solid dispersion body of the present invention has comprehensive advantages of uniform content, good dissolution, high bioavailability and good stability, and the characteristics of environmental protection and easy industrialization achieving are provided.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a folic acid solid dispersion and a preparation method thereof. Background technique [0002] Folic acid (FolicAcid) belongs to the B vitamins, also known as vitamin M, vitamin Bc, vitamin B9, the chemical name is N-[4-[(2-amino-4-oxo-1,4-dihydro-6-pteridine ) methylamino] benzoyl] -L-glutamic acid, commonly known as pteroyl glutamic acid, the molecular formula is C 19 h 19 N 7 o 8 (The structural formula is as shown in the figure below), molecular weight 441.4, melting point 250°C, almost insoluble in water (solubility is about 0.0016mg / mL) and most organic solvents, soluble in dilute acid and alkaline solution. [0003] [0004] The history of clinical application of folic acid has a long history. Yang Yuzhu, Wang Prince Yan, etc. summarized the history of its discovery and application in the article "Research Progress of Folic Acid": as early as 1931, Dr. Lucy Wills, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61K47/34A61K47/32A61K47/26
Inventor 易斌安明榜韩妮娜
Owner 北京斯利安药业有限公司
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