Ferrous fumarate folic acid dispersible tablet and preparation method thereof

A technology of ferrous fumarate and dispersible tablets, which is applied to medical preparations, pharmaceutical formulations, organic active ingredients and other directions containing active ingredients, can solve problems such as no research reports on compound dispersible tablets, and achieve the prevention of iron deficiency anemia. , the production process is simple and the cost is low

Inactive Publication Date: 2010-03-17
SOUTHWEST UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But so far, there are no research reports on com

Method used

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  • Ferrous fumarate folic acid dispersible tablet and preparation method thereof
  • Ferrous fumarate folic acid dispersible tablet and preparation method thereof
  • Ferrous fumarate folic acid dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0039] The preparation method of the ferrous fumarate folic acid dispersible tablet of a preferred embodiment includes the following steps:

[0040] a. Crushing: crush ferrous fumarate and folic acid into fine powders with a fineness of 120 mesh or more, and crush the pharmaceutically acceptable carrier into fine powders with a fineness of 100 mesh or more;

[0041] b. Granulation: Mix the ferrous fumarate, folic acid, filler and internal disintegrant after crushing in step a (surfactant can also be added), and then add a binder to make a soft material, 18~ Granulate with a 24-mesh sieve, dry at 45℃~55℃, and pass the dried granules through a 20-24 mesh sieve;

[0042] c. Tableting: adding lubricant and external disintegrant (or flavoring agent can also be added) to the dry particles after granulation in step b, mixing, and tableting to obtain ferrous fumarate folic acid dispersible tablets.

[0043] The dispersible tablet of the present invention has relatively high drug content and p...

Example Embodiment

[0045] Example 1

[0046] prescription

[0047]

[0048] Manufacturing method The ferrous fumarate and folic acid were crushed into fine powders with a fineness of 120 mesh or more, and the remaining components were crushed into fine powders with a fineness of 100 mesh or more; ferrous fumarate 182g, folic acid 0.4g, microcrystalline Mix 190g of cellulose and 18g of croscarmellose sodium, add 2% povidone K30 aqueous solution to make soft material, granulate with 24 mesh sieve, dry at 50℃, and pass through 24 mesh sieve. Whole granules: Add 7g of magnesium stearate and 8g of micronized silica gel to the dry granules, mix them, and compress them to make 1000 dispersible tablets of ferrous fumarate and folic acid, each containing 60mg of iron and 0.4mg of folic acid.

[0049] quality The obtained dispersible tablet has a smooth and shiny appearance; it disintegrates completely within 2.1 minutes in 20±1℃ water, is evenly dispersed and can pass through the No. 2 sieve; the hardne...

Example Embodiment

[0050] Example 2

[0051] prescription

[0052]

[0053] Manufacturing method The ferrous fumarate and folic acid were crushed into fine powders with a fineness of 120 mesh or more, and the remaining components were crushed into fine powders with a fineness of 100 mesh or more; ferrous fumarate 182g, folic acid 0.4g, microcrystalline Mix 63g of cellulose, 147g of mannitol and 30g of cross-linked povidone, add 2% povidone K30 aqueous solution to make soft material, granulate with 24 mesh sieve, dry at 50℃, and pass the dry granules through 24 mesh Sieve the granules; add 8g of magnesium stearate and 6g of micronized silica gel to the dry granules, mix them, and compress them to make 1,000 dispersible tablets of ferrous fumarate and folic acid, each containing 60mg of iron and 0.4mg of folic acid.

[0054] quality The obtained dispersible tablet has a smooth and shiny appearance; it disintegrates completely within 1.5 minutes in water at 20±1℃, is evenly dispersed and can pass ...

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Abstract

The invention discloses a ferrous fumarate folic acid dispersible tablet and a preparation method thereof; the dispersible tablet is composed of 35-45 percent of composite of ferrous fumarate and folic acid and an acceptable carrier in pharmacy by mass percent; the mass ratio of ferric ions and folic acid in the composite of ferrous fumarate and folic acid is 150:1: the acceptable carrier in pharmacy comprises 30-60 percent of fillers, 2-10 percent of binding agents, 3-15 percent of disintegrants and 0.5-5 percent of lubricants by mass percent; the dispersible tablet is prepared by a wet granulation tabletting method and is rapidly disintegrated and evenly dispersed when meeting water, the effect is rapid, the bioavailability is high, and adverse reaction caused by overhigh local drug concentration of gastrointestinal tract can be alleviated or avoided, and the carrying and medicine taking are convenient; the preparation process is simple, the cost is low, the preparation is stable, safe and effective, thereby being suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a ferrous fumarate folic acid dispersible tablet and a preparation method of the ferrous fumarate folic acid dispersible tablet. Background technique [0002] Pregnant women are a special population with a high incidence of anemia. Studies have shown that women with anemia during pregnancy have a 5-fold increased risk of dying during pregnancy and childbirth, and are also more likely to have fetal malformations, premature birth and low birth weight. There are two main types of anemia that are most common during pregnancy: iron deficiency anemia and megaloblastic anemia. Iron deficiency anemia is hypochromic microcytic anemia in which hemoglobin synthesis is reduced due to iron deficiency in the body, and is the most common anemia during pregnancy. Pregnant women lose blood due to menstruation before pregnancy, resulting in insufficient iron storage in the body after pregnancy. Th...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K31/194A61K9/20A61P7/06A61P3/02
Inventor 罗永煌刘艳玲乔彦茹田朋鑫聂延君罗雷雷曙光陈君
Owner SOUTHWEST UNIVERSITY
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