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Iron sucrose injection and preparation method thereof

A technology of iron sucrose and injection, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve the problem of high raw material cost of dextran, susceptibility to infection and secondary diseases, and high prices of finished drugs, etc. To achieve the effect of improving treatment efficiency and treatment effect, easy control of the reaction process, and low production cost

Inactive Publication Date: 2013-04-17
TIANJIN ZHONGAO BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the iron element is not supplemented in time, it will bring the following unfavorable factors to piglets: (1) cannot form hemoglobin, myoglobin, cytochrome enzymes and various peroxidases, thereby affecting the delivery of nutrients in the body; (2) Low hemoglobin content, low oxygen-carrying and oxygen-supplying capacity, can easily cause body organ failure; (3) increased incidence of diarrhea, edema, white muscle disease, etc., slow growth, rough back hair, pale skin and mucous membranes, and loss of appetite; ( 4) Physiological function decline, low immunity, susceptibility to infection and secondary diseases
[0003] Iron dextran, which is currently used in clinical practice for piglets, is mainly iron dextran. Although this drug is effective in treating iron deficiency anemia in piglets, it has the following problems for long-term application: the synthesis of iron dextran is a very complicated process, and trivalent It is prepared by the complexation reaction between iron hydroxide and dextran molecules. The complexation reaction is very unstable and is affected by the pH value of the reaction system and FeCl 3 The concentration of the solution has a great influence, the product yield is low, the quality is poor, and the raw material cost of dextran is high, resulting in the high price of the finished drug, which affects its clinical application to a certain extent

Method used

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  • Iron sucrose injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0025] A preparation method of iron sucrose injection, the steps of the preparation method are:

[0026] (1), alkalization: dissolve 1 part of sucrose in 10 parts of distilled water, add 1 part of 10% sodium hydroxide solution, and stir and react for 1 hour at a temperature of 80°C; the lye can also be sodium carbonate solution, hydroxide One of potassium solution, ammonium hydroxide solution or potassium carbonate solution;

[0027] (2), complexation: after the reaction in step (1) finishes, add 10 parts of distilled water to the reaction solution obtained in step (1), control the temperature at 40°C, and add 50 parts of 20% ferric chloride solution dropwise under stirring , observe the pH change of the system during the dropping process. When the pH of the system is less than 2, add 10% lye dropwise at the same time to ensure that the pH of the system remains 3 during the dropping of the ferric chloride solution. After the dropwise addition is completed, adjust the pH of th...

Embodiment 2

[0033] A preparation method of iron sucrose injection, the steps of the preparation method are:

[0034] (1), alkalization: dissolve 10 parts of sucrose in 30 parts of distilled water, add 40 parts of 30% ammonium hydroxide solution, and stir and react at 120° C. for 4 hours;

[0035] (2), complexation: after the reaction of step (1) finishes, add 30 parts of distilled water in the reaction solution gained in step (1), control temperature 100 ℃, add dropwise 120 parts of 50% ferric acetate solution under stirring, drop Observe the pH change of the system during the addition process. When the pH of the system is less than 4, add 30% ammonium hydroxide solution dropwise at the same time to ensure that the pH of the system remains 6 during the dropping of the ferric acetate solution. After the ferric acetate solution is completely added dropwise , using 30% ammonium hydroxide solution to adjust the pH of the system to 8, stirring and reacting at 100°C for 6 hours to obtain a comp...

Embodiment 3

[0040] A preparation method of iron sucrose injection, the steps of the preparation method are:

[0041] (1), alkalization: dissolve 5 parts of sucrose in 20 parts of distilled water, add 20 parts of 20% potassium carbonate solution, stir and react at 100°C for 2 hours;

[0042] (2), complexation: after step (1) reaction finishes, add 20 parts of distilled water in step (1) gained reaction solution, control temperature 70 ℃, drip 80 parts of 35% ferric ammonium nitrate solution under stirring, Observe the pH change of the system during the dropping process. When the pH of the system is less than 3, add 20% potassium carbonate solution dropwise at the same time to ensure that the pH of the system remains 5 during the dropping of the ammonium ferric nitrate solution. After the ammonium ferric nitrate solution is completely added dropwise After completion, adjust the pH of the system to 7 with 20% potassium carbonate solution, and stir and react at 70° C. for 4 hours to obtain a ...

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Abstract

The invention relates to a preparation method of iron sucrose injection. The method comprises the steps of (1) alkalization; (2) complexation; (3) alcohol precipitation; (4) powder collection, comprising the procedures of performing solid-liquid separation on alcohol precipitation solution by a centrifugal machine, spray drying the solid phase and collecting powder to obtain a bulk drug of the iron sucrose; (5) injection preparation, comprises the steps of adding the bulk drug of the iron sucrose in injection water to prepare a solution containing 100-300 mg of iron element in every milliliter, adding a 20-40% NaOH solution for alkalization, controlling a pH value at 11, heating and controlling a temperature at 40-80 DEG C, then adding 1-0.3% of activated carbon, stirring for 15-60 minutes, filtering with a 0.22 [mu]m micro-filtration membrane, heating with steam and controlling the temperature at 110-120 DEG C, and keeping the temperature for 30 minutes to obtain a finished product of the iron sucrose injection. The preparation method of the iron sucrose injection is simple in process steps, has easily controllable reaction process, good product quality, high yield and low production cost, and is a preparation method of the iron sucrose injection, with relatively high innovativeness.

Description

technical field [0001] The invention belongs to the field of veterinary medicine, in particular to an iron sucrose injection and a preparation method thereof. Background technique [0002] In the feeding process of piglets, the intake of iron is very important. Iron is a trace element necessary for the body. It is an essential component for the body to synthesize hemoglobin. It is also myoglobin, cytochrome, and cytochrome. Components such as enzymes and peroxidases. Primary iron deficiency can cause anemia in newborn piglets. According to statistics, about 30% of piglets die due to iron deficiency. Piglets suffering from anemia mainly occur at the age of 2 to 4 weeks, and the faster the piglets grow, the more iron they store. The faster the amount is consumed, the higher the incidence of anemia. If the iron element is not supplemented in time, it will bring the following unfavorable factors to piglets: (1) cannot form hemoglobin, myoglobin, cytochrome enzymes and various ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7016A61P3/02
Inventor 安同伟陈庆忠郭嘉
Owner TIANJIN ZHONGAO BIOTECH
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