Preparation methods and quality control methods of polysaccharide-iron compound and capsule preparation

A technology of polysaccharide iron and complexes, which is applied in the preparation of capsule preparations and in the field of polysaccharide iron complexes. It can solve the problems affecting the quality of polysaccharide iron complexes, the difficulty of removing heavy metal ions, and the increase in the amount of polysaccharides. It achieves good separation and purification effects and reduces Heavy metal content, effect of reducing polysaccharide dosage

Active Publication Date: 2021-04-23
福建呈睿医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process of the disclosed polysaccharide-iron complex all adopts a one-step preparation method. During the synthesis process, ferric chloride, alkaline substances and polysaccharides are all in the same reaction vessel, because polysaccharides have the ability to complex with metal ions, and iron During complexation, it will also complex with heavy metal ions such as manganese, nickel, arsenic, and lead. The complexed heavy metals have the same dissolution characteristics as polysaccharide iron, making it difficult to remove the remaining heavy metal ions, especially the content of lead and arsenic, which seriously affects Quality of Polysaccharide Iron Complex
At the same time, because heavy metal ions need to consume polysaccharides during the complexation process, the amount of polysaccharides increases and the cost increases

Method used

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  • Preparation methods and quality control methods of polysaccharide-iron compound and capsule preparation

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Experimental program
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Effect test

Embodiment 1

[0055] Embodiment 1: Preparation of ferric hydroxide colloid

[0056] The preparation of ferric hydroxide colloid comprises the following steps:

[0057] (1) Take by weighing anhydrous sodium carbonate 118Kg, put in reaction tank, under stirring, be mixed with water to 25% concentration, stir until anhydrous sodium carbonate dissolves completely, obtain sodium carbonate solution;

[0058] (2) Take by weighing 190Kg of Liuheshui ferric chloride, put in reaction tank, under stirring, add water and be mixed with 30% concentration, stir until Liuheshui ferric chloride dissolves completely; Under stirring, sodium carbonate solution is passed through metering pump , into the reaction tank of the solution of ferric chloride with a flow rate of about 10-12Kg per minute until the sodium carbonate solution is completely added.

[0059] (3) Reaction: After adding the sodium carbonate solution, continue to stir for 1 hour at 25° C., and use the cloud point inspection method to detect tha...

Embodiment 2

[0061] Embodiment 2: Preparation of ferric hydroxide colloid

[0062] The preparation of ferric hydroxide colloid comprises the following steps:

[0063] (1) Take by weighing anhydrous sodium carbonate 118Kg, put in reaction tank, under stirring, be mixed with water to 25% concentration, stir until anhydrous sodium carbonate dissolves completely, obtain sodium carbonate solution;

[0064] (2) Take by weighing 190Kg of Liuheshui ferric chloride, put in reaction tank, under stirring, add water and be mixed with 30% concentration, stir until Liuheshui ferric chloride dissolves completely; Under stirring, sodium carbonate solution is passed through metering pump , into the reaction tank of the solution of ferric chloride with a flow rate of about 10-12Kg per minute until the sodium carbonate solution is completely added.

[0065] (3) Reaction: After adding the sodium carbonate solution, continue to stir at 25° C. for 0.5 hour, adopt the cloud point test method to detect, the solu...

Embodiment 3

[0067] Embodiment 3: preparation ferric hydroxide colloid

[0068] The preparation of ferric hydroxide colloid comprises the following steps:

[0069] (1) Take by weighing anhydrous sodium carbonate 118Kg, put in reaction tank, under stirring, be mixed with water to 25% concentration, stir until anhydrous sodium carbonate dissolves completely, obtain sodium carbonate solution;

[0070] (2) Take by weighing 190Kg of Liuheshui ferric chloride, put in reaction tank, under stirring, add water and be mixed with 30% concentration, stir until Liuheshui ferric chloride dissolves completely; Under stirring, sodium carbonate solution is passed through metering pump , into the reaction tank of the solution of ferric chloride with a flow rate of about 10-12Kg per minute until the sodium carbonate solution is completely added.

[0071] (3) Reaction: After adding the sodium carbonate solution, continue to stir for 2 hours at 25° C., and use the cloud point inspection method to detect that ...

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Abstract

The invention belongs to the technical field of medicine preparation, and discloses preparation methods and quality control methods of a polysaccharide-iron compound and a capsule preparation. The preparation method comprises the following steps of (1) adding an alkaline substance into ferric salt, reacting, and washing a reactant mixture until the conductivity is less than 5 ms/cm to obtain a ferric hydroxide colloid; and (2) adding oligosaccharide syrup into the ferric hydroxide colloid prepared in the step (1), adjusting the pH value to 11-14, reacting, adjusting the pH value to be less than 7, generating precipitates, performing centrifuging, dissolving the obtained precipitates in a solution with the pH value of 11-14, and performing drying to obtain the polysaccharide-iron compound. The content of free iron in the polysaccharide-iron compound prepared by the method is less than 0.05%, the content of heavy metals is less than 7.5 ppm, the loss of syrup in the reaction process can be greatly reduced, and the cost is saved. The prepared polysaccharide-iron compound is used for preparing the capsule preparation.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a preparation method and a quality control method of a polysaccharide-iron complex and a capsule preparation. Background technique [0002] The polysaccharide-iron complex is a complex of starch oligosaccharides and ferric iron, and is used for treating iron deficiency anemia. The iron content in the polysaccharide-iron complex is 40-46%. As a raw material drug, the higher the content of iron element in the polysaccharide-iron complex, the better the effect of iron supplementation. Because the polysaccharide iron complex is completely absorbed in the form of molecules, it has little side effects on the gastrointestinal tract, and has no side effects such as nausea, abdominal pain, and diarrhea. [0003] At present, the preparation of polysaccharide iron complex at home and abroad is generally obtained by mixing oligosaccharide syrup, alkali, and ferric c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H23/00C07H3/02C07H3/04C07H1/00A61K31/7135A61K9/48A61P7/06G01N31/16G01N31/02G01N31/22
Inventor 邓华山冯建棋
Owner 福建呈睿医药科技有限公司
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