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Iron sucrose injection and preparation method thereof

A technology of iron sucrose and injection, which is applied in the field of injection containing iron sucrose to treat iron-deficiency anemia and the field of pharmaceutical compositions containing iron sucrose, which can solve problems such as precipitation and achieve the effect of low detection rate of visible foreign matter

Active Publication Date: 2014-12-10
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the inventors have found that some existing products have a higher probability of precipitation when stored at a lower temperature

Method used

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  • Iron sucrose injection and preparation method thereof
  • Iron sucrose injection and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0099] Embodiment 1, prepare iron sucrose injection (in every bottle of 5ml injection volume meter, prepare medicinal liquid 5000ml, the same below)

[0100] Prescription: Appropriate amount of iron sucrose (100 mg of iron, 315-330 mg of sucrose), appropriate amount of water for injection to a total of 5 ml, acid-base regulator 1M hydrochloric acid solution and 1M sodium hydroxide solution for later use.

[0101] Preparation method: (a) dissolve the iron sucrose in the calculated amount of the prescription in 2.5ml of water for injection under stirring;

[0102] (b) Add 0.1% (w / v) activated carbon to the medicinal solution obtained in step (a), then adjust the pH value of the solution to 6.0±0.1 with 1M hydrochloric acid solution under stirring, and then make the medicinal solution at a temperature of 60-70°C Lower heat preservation and adsorption for 25 minutes (in the present invention, it can be referred to as the first adsorption or neutral carbon adsorption); then use 1...

Embodiment 2

[0104] Embodiment 2, preparation iron sucrose injection

[0105] Prescription: with embodiment 1.

[0106] Preparation method: (a) dissolve the iron sucrose in the calculated amount of the prescription in 2.25ml of water for injection under stirring;

[0107] (b) Add 0.2% (w / v) activated carbon to the medicinal solution obtained in step (a), then adjust the pH value of the solution to 5.6±0.1 with 1M hydrochloric acid solution under stirring, and then make the medicinal solution at a temperature of 60-70°C Insulate and absorb for 20 minutes; then use 1M sodium hydroxide solution to adjust the pH value of the solution to 10.7-10.9, continue to keep the drug solution at 60-70°C for 15 minutes, and decarbonize by filtering with a 0.8μm microporous membrane;

[0108] (c) Add water for injection to the full amount of the prescription, check the pH value of the solution, and adjust the pH value of the solution to the range of 10.7 to 10.9 with an acid-base regulator if necessary;...

Embodiment 3

[0109] Embodiment 3, preparation iron sucrose injection

[0110] Prescription: with embodiment 1.

[0111] Preparation method: (a) dissolve the iron sucrose in 2.75ml of water for injection under stirring;

[0112] (b) Add 0.05% (w / v) activated carbon to the medicinal solution obtained in step (a), then adjust the pH value of the solution to 6.4±0.1 with 1M hydrochloric acid solution under stirring, and then make the medicinal solution at a temperature of 60-70°C Insulate and absorb for 30 minutes; then use 1M sodium hydroxide solution to adjust the pH value of the solution to 10.7-10.9, continue to keep the liquid at 60-70°C for 10 minutes, and decarbonize by filtering with a 0.8 μm microporous membrane;

[0113] (c) Add water for injection to the full amount of the prescription, check the pH value of the solution, and adjust the pH value of the solution to the range of 10.7 to 10.9 with an acid-base regulator if necessary; use 0.4 μm and 0.22 μm microporous membranes for ...

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Abstract

The invention relates to iron sucrose injection and a preparation method thereof. The iron sucrose injection comprises iron sucrose serving as an active ingredient, an optional acidifying or alkalizing agent and water for injection. The iron sucrose injection is characterized in that the pH value is 10.0-11.5, the osmotic pressure is 1100-1400mOsmol / L, 1ml of iron sucrose injection contains 15-25mg of iron and 240-400g of sucrose, the turbid point is in the range from 4.4-5.3 based on pH, the weight-average molecular weight (MW) is in the range from 34000-60000Da, the number-average molar mass (Mn) is no less than 24000Da, and the molecular weight distribution is less than 1.7 by Mw / Mn. The iron sucrose injection can be used for specially treating iron-deficiency anemia, can be used for intravenous administration in an instillation or slow injection manner and is suitable for patients which do not have good response to oral iron preparations and need to undergo intravenous iron preparation treatment, such as patients which cannot tolerate the oral iron preparations and cannot absorb the oral iron preparations well.

Description

technical field [0001] The invention relates to an iron-containing pharmaceutical composition, in particular to a pharmaceutical composition containing iron sucrose, and more particularly to an injection containing iron sucrose. The invention also relates to a process for the preparation of the composition. The composition of the present invention is particularly useful for the treatment of iron deficiency anemia, especially the composition can be intravenously administered by infusion or slow injection and is suitable for patients who need intravenous iron treatment because of poor oral iron effect, such as Patients who cannot tolerate oral iron and in whom oral iron is poorly absorbed. Background technique [0002] As we all know, iron is an essential trace element for the human body. Iron deficiency due to insufficient intake, limited utilization or other reasons is quite common. Iron deficiency anemia is the most widely distributed nutritional deficiency disease in the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/7016A61P7/06
Inventor 赵东明贾红军谷娟潘旭余茹董国明
Owner CHENGDU TIANTAISHAN PHARMA
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