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Citric acid ferric pyrophosphate solution and preparation method thereof

A technology of ferric citrate pyrophosphate solution, which is applied in the field of medicine, can solve problems such as side effects, reduction of biological effectiveness, metal element utilization rate and deposition efficiency limitation, and achieve high safety and avoid toxic reactions

Inactive Publication Date: 2017-05-10
泰州海达医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The antagonism between different metal elements will also limit the utilization and deposition efficiency of metal elements absorbed into the body, resulting in a decrease in their bioavailability
However, there are serious side effects when traditional iron for injection is used, and there are serious deficiencies.

Method used

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  • Citric acid ferric pyrophosphate solution and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0015] A ferric citrate pyrophosphate solution comprises the following components: 4.352 g of ferric citrate pyrophosphate (calculated as iron content), an appropriate amount of anhydrous sodium carbonate, sodium citrate and water for injection. The water for injection is sterile filtered water without other substances. The molecular formula of the iron citrate pyrophosphate is Fe 4 (C 6 h 4 o 7 ) 3 (H 2 P 2 o 7 ) 2 (P 2 o 7 ), the preparation process of this ferric citrate pyrophosphate is disclosed in the literature of the patent No. US7816404, and its structural formula is as follows figure 1 shown.

[0016] Its preparation method is as follows:

[0017] (1) Measure 80% of the prescribed amount of water for injection;

[0018] (2) Weigh ferric citrate pyrophosphate and add it to the water for injection in step (1). Adjust the pH value to 4.0~5.5, fully stir to dissolve, and then add water for injection to make up to the prescription volume of 1000ml;

[0019]...

Embodiment 2

[0025] A ferric citrate pyrophosphate solution comprises the following components: 4.896 g of ferric citrate pyrophosphate (calculated as iron content), an appropriate amount of sodium bicarbonate, sodium citrate, citric acid and water for injection. The water for injection is sterile filtered water without other substances. The molecular formula of the iron citrate pyrophosphate is Fe 4 (C 6 h 4 o 7 ) 3 (H 2 P 2 o 7 ) 2 (P 2 o 7 ), the preparation process of this ferric citrate pyrophosphate is disclosed in the literature of the patent No. US7816404, and its structural formula is as follows figure 1 shown.

[0026] Its preparation method is as follows:

[0027] (1) Measure 80% of the prescribed amount of water for injection;

[0028] (2) Weigh ferric citrate pyrophosphate and add it to the water for injection in step (1), the addition amount is 4.896g based on the iron content, use sodium bicarbonate solution, sodium citrate solution, citric acid solution One or...

Embodiment 3

[0033] A ferric citrate pyrophosphate solution comprises the following components: 5.440 g of ferric citrate pyrophosphate (calculated as iron content), an appropriate amount of anhydrous sodium carbonate and water for injection. The water for injection is sterile filtered water without other substances. The molecular formula of the iron citrate pyrophosphate is Fe 4 (C 6 h 4 o 7 ) 3 (H 2 P 2 o 7 ) 2 (P 2 o 7 ), the preparation process of this ferric citrate pyrophosphate is disclosed in the literature of the patent No. US7816404, and its structural formula is as follows figure 1 shown.

[0034] Its preparation method is as follows:

[0035] (1) Measure 80% of the prescribed amount of water for injection;

[0036](2) Weigh ferric citrate pyrophosphate and add it to the water for injection in step (1), the amount added is 5.440g based on the iron content, and adjust the pH value to 4.0~5.5 with 20% (W / V) sodium carbonate solution , fully stirred to dissolve, and t...

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Abstract

The invention discloses a citric acid ferric pyrophosphate solution. The citric acid ferric pyrophosphate solution is prepared from the following components: 4.352g-6.528g of citric acid ferric pyrophosphate (according to the content of iron), one or more pH (Potential of Hydrogen) regulators and a proper amount of injection water. The citric acid ferric pyrophosphate solution is yellow green clarified liquid; and the iron labeled amount of each millimeter of the solution is 5.44mg. The pH regulator comprises anhydrous sodium carbonate, sodium hydrogen carbonate, sodium citrate, citric acid, sodium hydroxide and solutions thereof. A preparation method comprises the following steps: adding the citric acid ferric pyrophosphate into the injection water and stirring, and dissolving; regulating the pH value to be 4.0-5.5 by utilizing the pH regulator, and sufficiently stirring and dissolving; after dissolving, adding the injection water until the volume is 1000ml; weighing 0.01%-0.5% (W / V) of active carbon and adding into the solution; stirring at a temperature of 40 DEG C-60 DEG C for 30min-60min; decarbonizing and filtering, sterilizing and filtering, and filling; and detecting and packaging. The citric acid ferric pyrophosphate solution disclosed by the invention has high safety performance; the preparation method is simple to operate and special equipment is not needed; and a preparation period is short and the cost is relatively low.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to the field of ferric citrate pyrophosphate solution and a preparation method thereof. Background technique [0002] With the continuous improvement of people's living standards, the broad masses of the people pay more and more attention to their health. In order to prevent and control iron deficiency anemia, various approaches have been taken, such as dietary approach, food fortification, etc., and good results have been achieved. However, for pregnant women, children and other patients with severe iron deficiency anemia, drug treatment is particularly necessary. [0003] Early treatment methods are mostly oral inorganic iron salts, the most common being ferrous sulfate. After the inorganic metal iron salt is ingested by the human body, some metal ions are not only difficult to be absorbed, but also stimulate the gastrointestinal tract and cause diarrhea. The antagonism betwee...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/555A61P3/02
CPCA61K47/02A61K9/08A61K31/555
Inventor 陆小平王华
Owner 泰州海达医药科技有限公司
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