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Iron-polysaccharide complex enteric capsule and preparation method thereof

A technology of enteric-coated capsules and complexes, which is applied in the field of medicine, can solve the problems of unfilled sustained and controlled release preparations, inconvenient administration methods, and unfavorable iron digestion and absorption, and achieve increased drug safety, low drug production costs, and gastric The effect of intestinal irritation is small

Pending Publication Date: 2021-12-03
南京恒生制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The traditional drug for treating IDA is ferrous sulfate, and taking ferrous sulfate can stimulate the stomach and intestines, cause vomiting, and hinder the digestion and absorption of iron.
Ferrous iron is easy to generate endogenous free radicals, leading to cell membrane lipid peroxidation and cell membrane damage
[0005] Currently on the market, iron sucrose and iron carboxymaltose are only in the form of injections, which are inconvenient for administration, poor patient compliance, and potentially fatal allergic reactions. The safety is not high, and the drug cost is high
Polysaccharide-iron complexes only have ordinary immediate-release preparations on the market, and sustained-release preparations have not yet been blank.

Method used

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  • Iron-polysaccharide complex enteric capsule and preparation method thereof
  • Iron-polysaccharide complex enteric capsule and preparation method thereof
  • Iron-polysaccharide complex enteric capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Iron sucrose complex enteric-coated capsules

[0033] prescription

[0034]

[0035]

[0036] Preparation Process

[0037] ① Weigh the prescribed amount of carboxymethyl cellulose, prepare a solution with purified water, and pass through a 200-mesh sieve for later use.

[0038] ② Weigh the prescribed amount of sucrose core and place it in the centrifugal granulation coating machine, add the prescribed amount of iron sucrose and the pre-configured carboxymethyl cellulose solution to make pellets, pass through a 40-mesh sieve, and place in a high-efficiency boiling Boiling drying at 60°C in a dryer.

[0039] ③Weigh the polyacrylic acid resin, polyethylene glycol, and castor oil of the prescribed amount, prepare an ethanol solution, and pass through a 200-mesh sieve for later use.

[0040] ④Put the above-mentioned drug-containing pill cores into a centrifugal granulation coating machine, and use the above-mentioned coating solution to coat until the weig...

Embodiment 2

[0042] Example 2 Carboxymaltose iron complex enteric-coated capsules

[0043] prescription

[0044] name Dosage (mg) Proportion (%) Iron carboxy maltose 535.7 71.8 Cane sugar core 110.8 14.8 carboxymethyl cellulose 9.8 1.3 polyacrylic resin 76.2 10.2 polyethylene glycol 8.6 1.2 castor oil 4.9 0.7 Gelatin Empty Capsules 1 capsule /

[0045] Preparation Process

[0046] ① Weigh the prescribed amount of carboxymethyl cellulose, prepare a solution with purified water, and pass through a 200-mesh sieve for later use.

[0047] ② Weigh the prescribed amount of sucrose ball core and place it in the centrifugal granulation coating machine. At the same time, add the prescribed amount of carboxymaltose iron and the pre-configured carboxymethyl cellulose solution to make pellets. After passing through a 40-mesh sieve, place it in the flow Boiling and drying at 50°C in a chemical bed.

[0048] ③Weigh the polyacrylic aci...

Embodiment 3

[0051] Example 3 Polysaccharide-iron complex enteric-coated capsules

[0052] prescription

[0053] name Dosage (mg) Proportion (%) polysaccharide iron complex 350.2 66.1 Cane sugar core 108.3 20.4 Povidone 5.5 1.0 polyacrylic resin 56.8 10.7 polyethylene glycol 6.8 1.3 triacetin 2.6 0.5 Gelatin Empty Capsules 1 capsule /

[0054] Preparation Process

[0055] ① Weigh the prescribed amount of povidone, prepare a solution with purified water, and pass through a 200-mesh sieve for later use.

[0056] ② Weigh the prescribed amount of sucrose core and place it in the centrifugal granulation coating machine. At the same time, add the prescribed amount of polysaccharide-iron complex and pre-configured povidone solution to make pellets. After passing through a 40-mesh sieve, place in a fluidized Boiling and drying at 50°C in the bed.

[0057] ③Weigh the polyacrylic acid resin, polyethylene glycol, and triacetin in th...

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Abstract

The invention discloses an iron-polysaccharide complex enteric capsule and a preparation method thereof. The capsule preparation consists of a gelatin capsule and iron-polysaccharide complex enteric capsule compositions. The compositions consist of the following raw and auxiliary materials in percentage by weight: 65.0%-81.0% of an iron-polysaccharide complex, 9.3%-21.5% of a blank pellet core, 0.7%-2.0% of an adhesive, 7.0%-15.6% of an enteric coating material, 0.5%-3.2% of a pore-foaming agent and 0.1%-1.0% of a plasticizer, wherein the sum of the components is 100% in weight percentage. According to the invention, the iron-polysaccharide complex is prepared into the enteric capsule that is a sustained and controlled release preparation with intestinal release instead of gastric release, so that the intense stimulation to the gastrointestinal tracts caused by over-high local medicine concentration can be effectively avoided. Meanwhile, the iron-polysaccharide complex is absorbed without being influenced by food and gastric acid reduction, and released in the intestinal tracts, thereby achieving high bioavailability, more effective absorption by the human body, and a better curative effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a sugar-iron complex enteric-coated capsule and a preparation method thereof. Background technique [0002] Iron-deficiency anemia (Iron-deficiency Anaemia, IDA) is a common nutritional disease. The traditional drug for treating IDA is ferrous sulfate, and taking ferrous sulfate can stimulate the stomach and intestines to cause vomiting and is not conducive to the digestion and absorption of iron. Ferrous iron is easy to generate endogenous free radicals, leading to cell membrane lipid peroxidation and cell membrane damage. Iron dextran and iron gluconate have been widely used in the United States since the 1990s. Iron dextran is used to treat iron deficiency anemia in patients with renal failure through intravenous infusion, which avoids the problems of irritating the stomach and hindering digestion and absorption, but some patients have allergic problems. Since ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/50A61K47/32A61K47/10A61K33/26A61P7/06
CPCA61K9/5026A61K9/5031A61K33/26A61P7/06
Inventor 程冉童敬浩
Owner 南京恒生制药有限公司
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