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Iron sucrose injection and preparation method thereof

A technology of iron sucrose and injection, which is applied in the directions of blood diseases, pharmaceutical formulations, extracellular fluid diseases, etc., can solve the problems of energy consumption, large discharge pollution, unstable product quality, low product yield and other problems in the production process, and achieves a high level of product quality. High yield, low impurity content and good quality stability

Inactive Publication Date: 2018-04-13
SHANXI WEIQIDA GUANGMING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The existing production process of iron sucrose injection has relatively large energy consumption and emission pollution, low product yield, many impurities, and unstable product quality

Method used

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  • Iron sucrose injection and preparation method thereof

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Effect test

preparation example Construction

[0038] A kind of preparation method of iron sucrose injection of the present invention comprises:

[0039] figure 1 For the preparation flowchart of iron sucrose injection in a kind of embodiment of the present invention, please refer to figure 1 .

[0040] Iron sucrose injection is a small-volume injection, and there is no special requirement on the osmotic pressure of the preparation. However, in order to minimize the risk of medication due to inappropriate osmotic pressure, it should be as close as possible to the osmotic pressure of normal human blood (285-310mOsmol / kg). Therefore, the dosage of the isotonic regulator of the preparation is screened here.

[0041] Before the research on the prescription system of the preparation, the interaction between the main drug and the excipients should be investigated first. For injections, the pH of the system will not only affect the solubility of the main drug, but also affect the stability of the main drug. Ultimately affect...

Embodiment 1

[0055] This embodiment provides a preparation method of iron sucrose injection. In the present embodiment, the formulation prescription is as follows:

[0056] 1.5 g of iron sucrose raw material, an appropriate amount of 1M sodium hydroxide, and water as a solvent, so that the pH value of the entire dispersion system was adjusted to 11, and 5 ml of the first dispersion system was obtained.

[0057] No activated carbon was added to the first dispersion.

[0058] When the iron sucrose raw material and sodium hydroxide are mixed with water as the solvent, the temperature is maintained at 80°C when the diluted mixing tank is used for dilute mixing.

[0059] For injections, the pH of the system will not only affect the solubility of the main drug, but also affect the stability of the main drug. Ultimately affect the safety of medication. Therefore, the influence of pH on the stability of the main drug is very important. In this embodiment, the preparation sequence is:

[0060] K...

Embodiment 2

[0065] This embodiment provides a preparation method of iron sucrose injection. In the present embodiment, the formulation prescription is as follows:

[0066] 1.8 g of iron sucrose raw material, an appropriate amount of 1M sodium hydroxide, and water as a solvent, so that the pH value of the entire dispersion system was adjusted to 11.2, and 5 ml of the first dispersion system was obtained.

[0067] No activated carbon was added to the first dispersion.

[0068] When mixing the raw material of iron sucrose and sodium hydroxide with water as the solvent, the temperature is maintained at 85°C during the dilution in the dilution tank.

[0069] For injections, the pH of the system will not only affect the solubility of the main drug, but also affect the stability of the main drug. Ultimately affect the safety of medication. Therefore, the influence of pH on the stability of the main drug is very important. In this embodiment, the preparation sequence is:

[0070] Keep the te...

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Abstract

The invention relates to the technical field of medicine preparation, and discloses an iron sucrose injection and a preparation method thereof. The preparation method of the iron sucrose injection comprises the following steps: diluting a disperse system containing an iron sucrose raw material; adjusting the pH value of the disperse system containing the iron sucrose raw material to be alkaline soas to obtain a first disperse system; filtering the first disperse system; filling the filtered first disperse system, and then carrying out melt sealing; after the filling and melt sealing operations are finished, sterilizing the first disperse system, wherein the diluting operation is carried out at the temperature of 80-90 DEG C. The prepared iron sucrose injection meets the requirement in theaspect of content, and is low in impurity content, good in stability, environmentally-friendly and energy-saving in technological process and high in product yield. The iron sucrose injection prepared by the method has the characteristics of being low in impurity content, good in quality stability, and the like.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to an iron sucrose injection and a preparation method thereof. Background technique [0002] Iron deficiency is the second cause of anemia in hemodialysis patients. Iron loss related to hemodialysis is one of the causes of iron deficiency. Insufficient synthesis of erythropoietin in patients with uremia. Recombinant human erythropoietin can effectively treat uremia. anemia. The efficacy of erythropoietin depends on the iron storage in the patient's body. Usually, more than half of the patients treated with erythropoietin will have poor efficacy due to iron deficiency. There are also some patients with reduced renal excretion, normal or elevated iron storage, but reduced iron utilization, iron cannot be released quickly to meet the hematopoietic needs of the bone marrow, resulting in functional iron deficiency, resulting in reduced curative effect, or even ineffective, ...

Claims

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Application Information

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IPC IPC(8): A61K33/26A61K9/08A61K47/26A61P7/06
CPCA61K9/0019A61K9/08A61K33/26A61K47/26
Inventor 王泽山陈进朝陈丽琼
Owner SHANXI WEIQIDA GUANGMING PHARMA
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