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Preparation method for iron sucrose bulk drug and injection thereof

A technology of iron sucrose and raw material medicine, which is applied in the preparation of sugar derivatives, pharmaceutical formulations, chemical instruments and methods, etc., can solve problems such as unstable complexation reactions, low hemoglobin content, low oxygen carrying and oxygen supply capabilities, and achieve Reduce the injection dose and injection frequency, increase blood hemoglobin content, and control the reaction process easily

Inactive Publication Date: 2010-03-17
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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  • Preparation method for iron sucrose bulk drug and injection thereof
  • Preparation method for iron sucrose bulk drug and injection thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A preparation method of iron sucrose bulk drug, the steps are:

[0028] (1), crystallization: the pH value that concentration is 60% sucrose solution is adjusted to 1.5 with acetic acid, is that the iron salt solution 50ml of 1mol / L joins in the 100ml sucrose solution with acetic acid to form mixed solution, and iron salt solution is trichloro One of ferric chloride solution, ferric nitrate solution, ferric citrate solution, ferric acetate solution, ferric perchlorate solution, ferric ammonium citrate solution, ferric ammonium nitrate solution or ferric glycerophosphate solution, the iron salt solution in this embodiment uses Ferric chloride solution, with a concentration of 30% Na 2 CO 3 Solution Adjust the pH value of the mixed solution to 1.7, stir for 30 minutes, and continue to add a concentration of 30% Na 2 CO 3 The solution is just turbid in the mixed solution and the pH value of the mixed solution is adjusted to 4, filtered, and water is added to the filtere...

Embodiment 2

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

[0034] (1), crystallization: the pH value that concentration is 50% sucrose solution is adjusted to 1 with acetic acid, is that the iron salt solution 30ml of 10mol / L joins in the 300ml sucrose solution with acetic acid to form mixed solution, and iron salt solution is trichloro One of ferric chloride solution, ferric nitrate solution, ferric citrate solution, ferric acetate solution, ferric perchlorate solution, ferric ammonium citrate solution, ferric ammonium nitrate solution or ferric glycerophosphate solution, ferric nitrate solution is used in this embodiment , with a concentration of 30% Na 2 CO 3 Solution Adjust the pH value of the mixture to 1, stir for 20 minutes, and continue to add 20% Na 2 CO 3 The solution is just turbid in the mixed solution and the pH value of the mixed solution is adjusted to 4, filtered, and water is added to the obtained crystals to dissolve the crystals to obtain a d...

Embodiment 3

[0039] A preparation method of iron sucrose bulk drug, characterized in that: the steps of the method are:

[0040] (1), crystallization: the pH value that concentration is 80% sucrose solution is adjusted to 4 with acetic acid, is that the iron salt solution 60ml of 1mol / L joins in the 120ml sucrose solution with acetic acid to form mixed solution, and iron salt solution is trichloro One of ferric chloride solution, ferric nitrate solution, ferric citrate solution, ferric acetate solution, ferric perchlorate solution, ferric ammonium citrate solution, ferric ammonium nitrate solution or ferric glycerophosphate solution, the present embodiment adopts perchloric acid Iron solution, with a concentration of 50% Na 2 CO 3 Solution Adjust the pH value of the mixture to 3, stir for 40 minutes, and continue to add 50% Na 2 CO 3 The solution is just turbid in the mixed solution and the pH value of the mixed solution is adjusted to 7, filtered, and water is added to the obtained cry...

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Abstract

The invention relates to a preparation method for an iron sucrose bulk drug. The method comprises the following steps: (1) crystallization: the pH value of sucrose solution is adjusted to 1-4 with acetic acid, iron salt solution is added to the sucrose solution to form mixed liquor, the pH value of the mixed liquor is adjusted to 1-3 with Na2CO3 solution, then the mixed liquor is stirred and is continued to be added with the Na2CO3 solution until turbidity appears in the mixed liquor, the pH value of the mixed liquor is adjusted to 4-7, and then the mixed liquor is filtered and added with water to obtain iron cake solution; (2) complexing: the sucrose solution is heated and added with alkaline liquor for alkalization, and then the alkalized sucrose solution is added with the iron cake solution and stands for the night to obtain complexing solution; and (3) refining: the complexing solution after standing for the night is filtered, and the filtrate precipitates with 2-3 times of 95 percent of ethanol and is filtered to obtain the iron sucrose bulk drug. The invention has the advantages of simple process steps, easy control of the reaction processes, good product quality, high yieldand lower production cost and is a high-novelty preparation method for the iron sucrose bulk drug and the injection thereof.

Description

technical field [0001] The invention belongs to the field of iron supplements for piglets in the animal husbandry industry, in particular to a preparation method of an iron sucrose raw material drug and an injection. 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 f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H3/04C07H1/00A61K31/7016A61K9/08A61P3/02
Inventor 陈庆忠张福合安同伟郭嘉孙建曹桂敏李丹
Owner TIANJIN ZHONGAO BIOTECH
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