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Stable folic acid clathrate ferrous composition, preparation method and preparation thereof

A clathrate and composition technology, applied in the field of medicine, can solve the problems of poor water solubility, light, heat, humidity, oxygen instability, and easy degradation of folic acid, etc., and achieve low production cost, easy operation, and simple preparation method Effect

Active Publication Date: 2015-09-16
KPC PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Among the two active ingredients of ferrous salt folic acid tablets, folic acid has poor water solubility and is unstable to light, heat, humidity, oxygen and other factors, and is prone to degradation during preparation processing and product storage

Method used

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  • Stable folic acid clathrate ferrous composition, preparation method and preparation thereof
  • Stable folic acid clathrate ferrous composition, preparation method and preparation thereof
  • Stable folic acid clathrate ferrous composition, preparation method and preparation thereof

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preparation example Construction

[0021] The preparation method of the ferrous composition of the stable folic acid clathrate of the present invention comprises pretreatment and preparation steps, specifically comprising:

[0022] A. Pretreatment: The raw material folic acid clathrate is ground at low temperature and passed through an 80-mesh sieve, the ferrous salt is passed through a 100-mesh sieve, and the auxiliary materials are crushed through an 80-mesh sieve for later use.

[0023] B. Preparation: Mix the pretreated raw and auxiliary materials evenly according to the proportion to obtain the target product.

[0024] The preparation of the clathrate of raw material folic acid comprises the following steps:

[0025] A. Heat and melt the polyoxyethylene polyoxypropylene block copolymer in a water bath at 40~60°C;

[0026] B. Add folic acid according to the ratio under dark conditions, stir evenly, cool and solidify to obtain the target folic acid clathrate.

[0027] The preparation of the stable ferrous ...

Embodiment 1

[0072] Example 1 Prescription screening of ferrous fumarate and folic acid tablet cores (amount of 20,000 tablets)

[0073]

[0074] Preparation method: Weigh folic acid and poloxamer F188, mix them uniformly according to the principle of equal increase, and obtain folic acid mother powder, pass through an 80-mesh sieve for later use. Weigh the prescription amount of ferrous fumarate, lactose, crospovidone, povidone K30, microcrystalline cellulose and folic acid mother powder, mix evenly, then add the prescription amount of silicon dioxide, magnesium stearate, mix evenly , Determination of angle of repose, tableting.

[0075] Conclusion: The angle of repose is 29.7, the compressibility is good, and the friability is 0.1%.

Embodiment 2

[0076] Example 2 Screening of ferrous fumarate folic acid tablets prescription core (20,000 tablets dosage)

[0077]

[0078] Preparation method: the prescription amount of poloxamer F 188 40～60℃ Heat and melt, add the prescribed amount of folic acid under stirring, make it evenly mixed, cool to room temperature, crush, pass through an 80-mesh sieve, add the prescribed amount of microcrystalline cellulose, lactose, crospovidone, povidone K30 in turn, mix Evenly, then add the prescription amount of ferrous fumarate, mix evenly, finally add the prescription amount of silicon dioxide, magnesium stearate, mix evenly. Determination of angle of repose, tableting.

[0079] Conclusion: The angle of repose is 27.8, the compressibility is good, and the friability is 0.08%.

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Abstract

The present invention discloses a stable folic acid clathrate ferrous composition, a preparation method and a preparation thereof, wherein the stable folic acid clathrate ferrous composition comprises 30-40 parts by weight of a folic acid clathrate, 50-500 parts by weight of a ferrous salt and 185-550 parts by weight of an auxiliary material, the preparation method comprises pretreatment and preparation, and the preparation is powders, tablets, capsules and granules prepared by adding a pharmaceutically acceptable auxiliary material to the stable folic acid clathrate ferrous composition. With the composition and the preparation technology of the present invention, the stability of the existing folic acid and the folic acid in the ferrous salt preparation can be significantly improved, and the method is suitable for industrial scale production and application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a stable folic acid clathrate ferrous composition, a preparation method and a preparation thereof. Background technique [0002] Ferrous salt is an inorganic iron salt for treating iron-deficiency anemia. Ferrous fumarate has the advantages of higher iron content than traditional ferrous salt, ferrous sulfate, less stimulation of gastric mucosa, and quick effect. one of the main drugs. Folic acid (Folic Acid), also known as vitamin M, is a water-soluble B vitamin. When it is deficient, it can cause megaloblastic anemia and neonatal neural tube defects (NTDs). Although domestic clinics have long recognized the importance of simultaneously supplementing iron and folic acid to prevent anemia during pregnancy, there is no fixed-dose compound preparation containing two active ingredients, ferrous fumarate and folic acid, yet in China. In foreign countries, ferrous salt / ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K9/20A61K9/14A61K9/16A61K31/519A61K33/26A61K47/34A61P3/02A61P7/06A61K31/194A61K31/191
Inventor 廖荣朱常成王珺邓太琼
Owner KPC PHARM INC
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