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A kind of ferrous fumarate docusate sodium capsule

A technology of ferrous fumarate and docusate sodium, applied in the directions of capsule delivery, ester active ingredients, digestive system, etc., can solve iron malabsorption, difficult to maintain ferrous fumarate, unable to achieve industrial production, etc. question

Active Publication Date: 2018-04-10
哈尔滨瀚钧现代制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

2. Iron malabsorption: iron deficiency anemia due to iron absorption disorder is relatively rare
[0012] Ferrous fumarate is very easy to oxidize. When preparing its solid oral preparation, moisture needs to be controlled to prevent oxidation. Those skilled in the art clearly understand that directly filling common capsules after only adding common excipients is equivalent to untreated Provide protective measures for ferrous fumarate. When it is combined with docusate sodium to make solid preparations, the difficulty lies in that it is difficult to maintain the moisture content that does not oxidize ferrous fumarate. Currently, there is no high-purity ferrous fumarate on the market. Docusate sodium, and the unique physical properties of docusate sodium (viscous wax) determine that it is difficult to make solid preparations such as granules, capsules, tablets, etc. There is no raw material drug that can be provided for the drug in this combination form
It is especially difficult to fill capsules on the assembly line of industrialized mass production, which actually does not achieve the purpose of industrialized production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Embodiment 1, a kind of ferrous fumarate docusate sodium capsules (200000 grains, specification is 330mg / grain)

[0075] Docusate sodium 20.0kg, ferrous fumarate 30.0kg, starch 16.0kg, sodium benzoate 0.2kg, 98% ethanol 6000ml.

[0076] The capsules are made by the following method:

[0077] Docusate sodium was first mixed with 8.0kg of starch (docusate sodium: starch was 1:0.4), stirred, and the mixture of docusate sodium and starch obtained was mixed with 6.0kg of starch again (docusate sodium : starch is 1:0.3), crosses 80 mesh sieves, obtains the fine granule after docusate sodium and starch mix homogeneously; Mix ferrous fumarate and surplus starch; Mix docusate sodium starch mixture with fumarate The acid ferrous starch mixture is mixed, sodium benzoate and 98% ethanol are added, mixed and granulated in a granulator, dried at 45° C., granulated, and filled into capsules.

Embodiment 2

[0078] Embodiment 2, a kind of ferrous fumarate docusate sodium capsules (200000 grains, specification is 330mg / grain)

[0079] Docusate sodium 20.0kg, ferrous fumarate 30.0kg, starch 16.0kg, sodium benzoate 0.2kg, 98% ethanol 6000ml.

[0080] How to make the capsules:

[0081] Mix docusate sodium and starch for 3 times, stir, break up, the amount of starch added each time is 30% of docusate sodium, after 3 times of mixing, pass the mixture through an 80-mesh sieve to obtain docusate sodium Fine granules after uniformly mixing with starch; uniformly mixing ferrous fumarate with the remaining starch; mixing docusate sodium starch mixture with ferrous fumarate starch mixture, adding sodium benzoate and 98% ethanol, and preparing Mix and granulate in a granulator, dry, granulate, and fill capsules. The drying temperature was 45°C.

Embodiment 3

[0082] Embodiment 3, a kind of ferrous fumarate docusate sodium capsules (200000 grains, specification is 330mg / grain)

[0083] Docusate sodium 20.0kg, ferrous fumarate 30.0kg, starch 15-17.0kg, sodium benzoate 0.2kg, 98% ethanol 6000ml.

[0084] The preparation method of this capsule is with reference to the method for embodiment 1.

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PUM

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Abstract

The invention provides a ferrous fumarate docusate sodium capsule and a preparation method of the capsule, as well as a technological method for synthesizing medicinal-level high-purity docusate sodium, wherein in terms of 1 part of docusate sodium by weight, the capsule consists of 1.5 parts by weight of ferrous fumarate, 0.75-0.85 parts by weight of starch and 0.005-0.015 parts by weight of benzoic acid. The product has effects of replenishing blood and iron to treat iron-deficiency anemia and simultaneously to prevent and treat constipation.

Description

technical field [0001] The invention relates to a ferrous docusate sodium fumarate capsule and a preparation method thereof, in particular to a ferrous docusate sodium fumarate capsule composed of raw materials improved through a synthesis process. The capsule of the invention is used for medicinal purposes High-grade and high-purity drugs are selectively delivered to the digestive system, which improves the effect and safety, reduces side effects, and prevents constipation while nourishing blood. Background technique [0002] Iron deficiency anemia (iron deficiency anemia, IDA) is a common anemia caused by the lack of iron in the body and affects the synthesis of hemoglobin. Both concentration and serum transferrin saturation were decreased. Typical cases of anemia are small cell hypochromic type. Iron-deficiency anemia is a common type of anemia that is prevalent all over the world. The incidence of this anemia is very high in women of childbearing age and infants and y...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/22A61K9/48A61P7/06A61P1/10A61K31/194
Inventor 李细海
Owner 哈尔滨瀚钧现代制药有限公司