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Measuring method of carbonate content in sevelamer carbonate

A technology for sevelamer carbonate and determination method, which is applied in the field of determination of carbonate content in sevelamer carbonate, can solve problems such as not considering carbon dioxide interference, not disclosing measurement steps, incomplete carbon dioxide absorption, etc., to achieve accurate The effect of high accuracy and precision and low cost

Inactive Publication Date: 2017-02-22
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the specific measurement steps are not disclosed
[0004] CN102680309A and CN202066728 disclose a method and device for measuring carbonate content in sevelamer carbonate, but CN102680309A uses sodium hydroxide solution for absorption, and the generated sodium carbonate is soluble in water, and carbon dioxide may not be completely absorbed The absorption device of CN202066728U only uses three bottles of absorption, without considering the interference of carbon dioxide in the air

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] (1) Fix a three-neck glass flask (100ml) A on a magnetic stirrer through an iron clamp, and cover the three ports a, b, and c with perforated rubber stoppers respectively. Insert a dropping funnel (100ml) B into the rubber stopper of the middle port b, and insert a short glass tube into the rubber stoppers of the other two ports. Prepare four 100ml Erlenmeyer flasks and cover them with double-hole rubber stoppers respectively. Insert two glass tubes into the rubber stoppers of each Erlenmeyer flask. One glass tube is slightly longer, about 1 cm from the bottom of the bottle, and the other is The glass tube is slightly shorter, about 1cm away from the bottle stopper. Connect the long glass tube of each Erlenmeyer flask with the short glass tube of another Erlenmeyer flask with a latex tube in turn. Use a latex tube to connect port a of the three-neck flask A to the nitrogen cylinder (through a pressure reducing valve), connect port c to the long glass tube of one of the...

Embodiment 2

[0046] (1) Fix a three-neck glass flask (100ml) A on a magnetic stirrer through an iron clamp, and cover the three ports a, b, and c with perforated rubber stoppers respectively. Insert a dropping funnel (100ml) B into the rubber stopper of the middle port b, and insert a short glass tube into the rubber stoppers of the other two ports. Prepare four 100ml Erlenmeyer flasks and cover them with double-hole rubber stoppers respectively. Insert two glass tubes into the rubber stoppers of each Erlenmeyer flask. One glass tube is slightly longer, about 1 cm from the bottom of the bottle, and the other is The glass tube is slightly shorter, about 1cm away from the bottle stopper. Connect the long glass tube of each Erlenmeyer flask with the short glass tube of another Erlenmeyer flask with a latex tube in turn. Use a latex tube to connect port a of the three-neck flask A to the nitrogen cylinder (through a pressure reducing valve), connect port c to the long glass tube of one of the...

Embodiment 3

[0058] (1) Fix a three-neck glass flask (100ml) A on a magnetic stirrer through an iron clamp, and cover the three ports a, b, and c with perforated rubber stoppers respectively. Insert a dropping funnel (100ml) B into the rubber stopper of the middle port b, and insert a short glass tube into the rubber stoppers of the other two ports. Prepare four 100ml Erlenmeyer flasks and cover them with double-hole rubber stoppers respectively. Insert two glass tubes into the rubber stoppers of each Erlenmeyer flask. One glass tube is slightly longer, about 1 cm from the bottom of the bottle, and the other is The glass tube is slightly shorter, about 1cm away from the bottle stopper. Connect the long glass tube of each Erlenmeyer flask with the short glass tube of another Erlenmeyer flask with a latex tube in turn. Use a latex tube to connect port a of the three-neck flask A to the nitrogen cylinder (through a pressure reducing valve), connect port c to the long glass tube of one of the...

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Abstract

The invention relates to a measuring method of the carbonate content in sevelamer carbonate, and belongs to the technical field of medicine quantitative analysis. The method comprises the following steps: (1) installing a carbon dioxide generating device and an absorption device; (2) preparing a barium oxide absorption solution; (3) precisely weighing 1g of sevelamer carbonate, and adding the sevelamer carbonate into the carbon dioxide generating device; (4) adding the barium oxide absorption solution into the absorption device; (5) adding sulfuric acid into the sevelamer carbonate in the step (3); (6) performing titration on the barium oxide absorption solution by hydrochloric acid, and calculating the carbonate content in the sevelamer carbonate. The measuring method has the advantages that simplicity, convenience and high speed are realized; the cost is low; the accuracy and the precision are high; the measuring method is more suitable for daily quality management by a production department.

Description

technical field [0001] The invention relates to a method for determining carbonate content in sevelamer carbonate, which belongs to the technical field of quantitative analysis of medicines. Background technique [0002] Sevelamer Carbonate is a nonabsorbable, calcium-free phosphate conjugate intended to replace the already approved sevelamer hydrochloride. The chemical composition of sevelamer carbonate is poly(allylamine-co-N,N'-diallyl-1,3 diamino-2-hydroxypropane) carbonate, which contains a variety of amine groups and is The carbons on the polymer backbone are separated. Amines are protonated in the GI tract, so these positive charges bind negative ions in the gut, such as phosphate released during digestion. Phosphorus dissociated from the polymer cannot be absorbed into the blood and is excreted in feces through the intestinal tract. On October 19, 2007, sevelamer carbonate was approved in the United States for the control of serum phosphorus levels in chronic kidn...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N31/16
CPCG01N31/16
Inventor 杜德平王剑平鹿慧于磊窦国华
Owner SHANDONG XINHUA PHARMA CO LTD
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