Preparation method of iron sucrose injection with low variable iron content

A technology for the preparation of injections and iron sucrose, which is applied to the preparation of sugar derivatives, chemical instruments and methods, and medical preparations containing active ingredients, etc., can solve the problems of narrow molecular weight of iron sucrose and does not involve variable iron content, etc., to achieve Improve the quality level, the production process is stable and controllable, and the effect of uniform and stable quality

Active Publication Date: 2021-02-05
南京恒生制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] Although there are many preparation methods for iron sucrose injection reported in the literature at present, none of them involve the control of the variable iron content in the product. For example, a method for preparing iron sucrose injection is introduced in the patent CN 104558064A. Stable quality, narrow molecular weight, easy industrial production

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  • Preparation method of iron sucrose injection with low variable iron content

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Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: preparation of iron sucrose injection

[0030] Weigh the iron sucrose raw material and water for injection with a mass ratio of 1:1.5 and add them to the liquid preparation tank, stir and dissolve, the temperature of the first water distillation concentration is 103 ° C, the time of water distillation is 1.5 h, and the temperature of the second water distillation concentration is 108 °C ℃, distilled and concentrated for 1 hour, the temperature of the third distilled and concentrated water is 120 ℃, and the time of distilled water is 1.5 hours, then add distilled water for injection, stir and dilute, after cooling to room temperature, add hydrochloric acid solution to adjust the pH to 10.5-11.0 , using a 0.22 μm PES filter membrane to circulate and filter 3 times, sterilize at 121°C for 15 minutes, and fill to obtain iron sucrose injection, the concentration is 20mgFe / mL (calculated as iron), and the content of variable iron is 2.21%. Ferrokinetic curve fit...

Embodiment 2

[0031] Embodiment 2: preparation of iron sucrose injection

[0032] Weigh the iron sucrose raw material and water for injection with a mass ratio of 1:3.5 and add them to the liquid mixing tank, stir and dissolve, the temperature of the first steamed water concentration is 104°C, the time of steamed water is 1.5h, and the temperature of the second steamed water concentrated Concentrate with distilled water at 110°C for 1.7 hours. The temperature for the third distilled water concentration is 117°C, and the time for distilled water is 1.2 hours. Then add distilled water for injection, stir and dilute, and after cooling to room temperature, add hydrochloric acid solution to adjust the pH to 10.5 ~11.0, filtered 4 times with a 0.22 μm PES circulating filter, sterilized at 121°C for 18 minutes, filled to obtain iron sucrose injection, the concentration is 20mgFe / mL (calculated as iron), and the content of variable iron is 2.10%. The correlation coefficient of variable ferrokinetic...

Embodiment 3

[0033] Embodiment 3: preparation of iron sucrose injection

[0034] Weigh the iron sucrose raw material and water for injection with a mass ratio of 1:2.2 and add them to the liquid mixing tank, stir and dissolve, the temperature of the first steamed water concentration is 103°C, the time of steamed water is 1.8h, and the temperature of the second steamed water concentrated 109°C, distilled and concentrated for 1.6h, the third time of distilled water was concentrated at 120°C, and the time of distilled water was 1.3h, then add distilled water for injection, stir and dilute, after cooling to room temperature, add hydrochloric acid solution to adjust the pH to 10.5 ~11.0, using 0.1 μm PES filter membrane to circulate and filter for 3 times, sterilize at 121°C for 20 minutes, and fill to prepare iron sucrose injection, the concentration is 20mgFe / mL (calculated as iron), and the content of variable iron is 2.09%. The correlation coefficient of variable ferrokinetic curve fitting ...

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Abstract

The invention relates to a method for preparing an iron sucrose injection with low variable iron content, and belongs to the technical field of medicines. The method comprises the following steps of carrying out high-temperature circulating concentration treatment on an iron sucrose bulk drug, adding water for injection to prepare an iron sucrose solution, regulating the pH value of the liquid medicine to 10.5-11.0, and carrying out filtration and sterilization treatment to obtain the iron sucrose injection with low variable iron content. The iron sucrose injection disclosed by the invention is low in variable iron content, high in safety, uniform and stable, and easy to realize industrial production.

Description

technical field [0001] The invention relates to a preparation method of an intravenous iron supplement with low fugitive iron content, in particular to a preparation method of iron sucrose injection with low fugitive iron content. Background technique [0002] Iron is an essential trace element for the human body and an important component of hemoglobin, myoglobin, cytochrome and various oxidases. Iron deficiency is very common due to insufficient intake, and iron deficiency anemia is the most widespread nutritional deficiency today. Iron supplementation therapy is very necessary for patients with iron deficiency anemia. Oral iron is commonly used in clinical treatment, but oral administration can irritate the gastrointestinal tract to a certain extent, easily cause nausea, vomiting, etc., and the bioavailability is low. Iron supplementation is less effective. Clinical studies have shown that intravenous iron supplementation can effectively overcome the shortcomings of ora...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K33/26A61K31/7016A61P7/06C07H3/04C07H1/00
CPCA61K9/08A61K9/0019A61K31/7016A61P7/06A61K33/26C07H3/04C07H1/00A61K2300/00
Inventor 李莹曹光龙童敬浩
Owner 南京恒生制药有限公司
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