A kind of folic acid solid dispersion 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 good stability, high content uniformity and good dissolution behavior
CN105395554BActive Publication Date: 2019-08-09北京斯利安药业有限公司

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
北京斯利安药业有限公司
Publication Date
2019-08-09

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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.
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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 (Folic Acid) 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-pheno Pyridine) 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 Wil...

Claims

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