CN106442860A - Measuring method of carbonate content in sevelamer carbonate - Google Patents
Measuring method of carbonate content in sevelamer carbonate Download PDFInfo
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- G01N31/16—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using titration
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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
The present invention relates in a kind of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate carbonate content assay method, belong to medicine quantitative analysis tech
Field.
Background technology
2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate (sevelamer Carbonate) be a kind of do not absorb, the phosphate binders of not calcic, in order to
Substitute the sevelamer hydrochloride having gone through to use.The chemical composition of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate is poly- (propylene ammonia -co- N, N '-two
Pi-allyl -1,3 diaminourea -2- hydroxy propanes) carbonate, comprise multiple amine groups, separated by the carbon on polymer backbone.
Amine protonates in the gastrointestinal tract, and therefore these positive charges can discharge for example in digestion process in conjunction with negative ion in enteron aisle
Phosphate.Phosphorus can not absorb in blood after dissociating from polymer, is drained in excrement mode by enteron aisle.October 19 in 2007
Day, 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate is approved for controlling the Patients with Chronic Kidney Disease receiving dialysis to control serum phosphorus levels in the U.S..Should
The market potential of kind is huge, and prospect is preferable.
In EDQM's assessment report (CHMP ASSESSMENT REPORT FOR Renvela；
Procedure No.EMEA/H/C/000993) in, 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate carbonate content can be divided using near-infrared and thermogravimetric
Analysis measures.But it is because instrument price is expensive, inconvenient in production division's dairy products quality control.For this reason, managing carbonic acid
In sevelamer, carbonic acid cements out, with form of carbon dioxide release, referring again to GB T 18204.24-2000 the 3rd method capacity
Titration, fully absorbs carbon dioxide, titration, through conversion, calculates 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate carbonate content.But it is open
Specific determination step.
CN102680309A, CN202066728 disclose a kind of method measuring carbonate content in 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate
And device, but it is to be absorbed using sodium hydroxide solution in CN102680309A, the sodium carbonate of generation is dissolved in water, titanium dioxide
Carbon has the incomplete possibility of absorption；The absorption plant of CN202066728U absorbs only with three bottles, does not consider in the air dioxy
Change the interference of carbon.Therefore remain a need for researching and developing a kind of measuring method of accurate high precision.
Content of the invention
It is an object of the invention to provide in a kind of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate carbonate content assay method, it is simply just
Victory, low cost, the degree of accuracy and high precision, are more suitable for the routine quality management of production division.
In 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate of the present invention, the assay method of carbonate content, comprises the following steps：
(1) carbon dioxide is installed to produce and absorption plant；
(2) prepare barium hydroxide absorbent solution；
(3) precision weighs 1g 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, adds it in carbon dioxide generation device；
(4) add barium hydroxide absorbent solution in absorption plant；
(5) sulfuric acid is added to be reacted in the 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate described in step (3)；Carbonic acid is cemented out, with two
Carbonoxide form discharges, and the carbon dioxide of generation is absorbed by barium hydroxide absorbent solution；
(6) barium hydroxide absorbent solution is titrated with hydrochloric acid, calculated the content of carbonate in 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate.
In step (1), carbon dioxide produces and the installation steps of absorption plant are as follows：
One three mouthfuls glass flask (100ml) A are fixed on magnetic stirring apparatus by iron clamp platform, three ports a, b, c
Add a cover plug with holes respectively.Dropping funel (100ml) B is inserted in the plug of middle port b, each slotting in the plug of another two mouths
Enter a short glass tube.Separately prepare four 100ml conical flasks, add a cover the plug with diplopore respectively, in the plug of every conical flask
Two glass tubes of insertion, a glass tube is slightly longer, and apart from bottom of bottle about 1cm, another glass tube is slightly short, apart from bottle stopper about 1cm.According to
The secondary long glass tube by each conical flask is connected with the short glass tube emulsion tube of another conical flask.With emulsion tube by there-necked flask
The a mouth of A is connected with nitrogen cylinder (by pressure-reducing valve), and c mouth is connected with the long glass tube of wherein conical flask, last
The short tube of conical flask C is communicated with air.
In step (2), the preparation steps of barium hydroxide absorbent solution are as follows：
Weigh 5.0g NaOH, 48.9g barium chloride dihydrate in 1000mL bottle, after adding 1000mL to boil cooling
Water, shaking makes solid matter dissolve, and obtains final product barium hydroxide absorbing liquid.(barium ions concentration is 0.2mol/L, hydroxide ion concentration
0.12mol/L).
The concrete operation step of step (3) is as follows：
The accurately weighed 1g of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, opens the b chewing-gum plug of flask A, 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate sample is placed in bottom of bottle,
Add water 0.5～1ml, sample is moistened and mixes, and puts into a magnet rotor, be then reinstalled plug in bottle.
Concrete operation step in step (4) is as follows：
The sodium hydroxide solution 50mL of 0.5mol/L is added in conical flask C；Connecting line, logical nitrogen 10 minutes, check
System air-tightness；Accurately measure 150mL barium hydroxide absorbing liquid, be averagely placed in the other three conical flask in addition to C, connect immediately
Adapter road.
The concrete operation step of step (5) is as follows：
Close the cock of dropping funel B, and be added thereto to the sulfuric acid solution of 40ml, 0.5mol/L；Open dropping funel
Cock, drips sulfuric acid solution with the speed of 4～5ml/min；Adjust nitrogen flow, make every 2 seconds in the conical flask being connected with flask A
A bubble of emerging is advisable.As sulfuric acid solution residue about 5ml, close dropping funel cock, open magnetic agitation switch, continue
Reaction 30 minutes；Reaction finishes, and closes magnetic agitation, closes nitrogen stream.
The concrete operation step of step (6) is as follows：
Absorbing liquid in three conical flasks of merging, in 250ml conical flask, adds instructions phenolphthalein solution 1, uses 0.5mol/L
HCI liquid is titrated to redness and disappears for terminal；Do one with method blank；It is calculated as follows carbonate content；Based on dry product
Calculate：
Carbonate content (%)=[(VEmpty-VSample) × C × 3.1]/W,
Wherein：VEmptyConsume titrating solution volume (ml) for blank；
VSampleFor sample consumption titrating solution volume (ml)；
C is titrating solution concentration (mol/L)；
W is test sample sample weighting amount (g).
The present invention compared with prior art, has the advantages that：
The present invention is absorbed using barium hydroxide solution, and the brium carbonate of generation forms precipitation, with prior art hydrogen-oxygen
Change sodium solution absorption phase ratio, barium hydroxide solution absorbing carbon dioxide is more complete；The present invention adopts three bottles of barium hydroxide solutions
Absorbing carbon dioxide, puts sodium hydroxide solution for the 4th bottle, for excluding the interference to experiment for the Carbon Dioxide in Air.The present invention exists
In the case of there is no expensive instrument, using volumetric titrimetry, determine 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate carbonate content, simple and convenient, cost
Low, the degree of accuracy and high precision, it is more suitable for the routine quality management of production division.
Specific embodiment
With reference to embodiment, the present invention is further illustrated, but it is not intended to limit the enforcement of the present invention.
Embodiment 1
(1) one three mouthfuls glass flask (100ml) A are fixed on magnetic stirring apparatus by iron clamp platform, three port a,
B, c add a cover plug with holes respectively.Dropping funel (100ml) B is inserted, in the plug of another two mouths in the plug of middle port b
Respectively insert a short glass tube.Separately prepare four 100ml conical flasks, add a cover the plug with diplopore, the glue of every conical flask respectively
Two glass tubes are inserted, a glass tube is slightly longer, and apart from bottom of bottle about 1cm, another glass tube is slightly short, apart from bottle stopper about in plug
1cm.Successively the long glass tube of each conical flask is connected with the short glass tube emulsion tube of another conical flask.Will with emulsion tube
The a mouth of there-necked flask A is connected with nitrogen cylinder (by pressure-reducing valve), c mouth is connected with the long glass tube of wherein conical flask,
The short tube of a conical flask C is communicated with air afterwards.
(2) weigh 5.0g NaOH, 48.9g barium chloride dihydrate in 1000mL bottle, add 1000mL to boil cooling
Water afterwards, shaking makes solid matter dissolve, and (barium ions concentration is 0.2mol/L, hydroxide ion to obtain final product barium hydroxide absorbing liquid
Concentration 0.12mol/L).
(3) accurately weighed 1.00062g 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, opens the b chewing-gum plug of flask A, by 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate sample
It is placed in bottom of bottle, add water 0.50ml, sample is moistened and mixes, put into a magnet rotor in bottle, be then reinstalled plug.
(4) add the sodium hydroxide solution 50mL of 0.5mol/L in conical flask C.By said apparatus connecting line, logical nitrogen
Gas 10 minutes, inspection system air-tightness.Accurately measure 150mL barium hydroxide absorbing liquid, be averagely placed in the other three cone in addition to C
In shape bottle, press said apparatus connecting line immediately.
(5) close the cock of dropping funel B, and be added thereto to 40ml sulfuric acid solution (0.5mol/L).Open dropping liquid leakage
Bucket cock, drips sulfuric acid solution with the speed of 4～5ml/min, adjusts nitrogen flow, makes every 2 in the conical flask being connected with flask A
A second bubble of emerging is advisable.As sulfuric acid solution residue about 5ml, close dropping funel cock, open magnetic agitation switch, continue
Continuous reaction 30 minutes.Reaction finishes, and closes magnetic agitation, closes nitrogen stream.
(6) merge absorbing liquid in three conical flasks and, in 250ml conical flask, add instructions phenolphthalein solution 1, use
0.5001mol/L HCI liquid is titrated to redness and disappears for terminal, titrating solution 26.62ml.Do blank a, titrating solution with method
36.15ml.Being calculated as follows carbonate content is 14.76%.Press dry product again and calculate carbonate content, this part of sample drying loses
Weigh 5.59%, conversion dry product carbonate content is 15.63%.
Carbonate content (%)=[(VEmpty-VSample) × C × 3.1]/W,
Wherein：VEmptyConsume titrating solution volume (ml) for blank；
VSampleFor sample consumption titrating solution volume (ml)；
C is titrating solution concentration (mol/L)；
W is test sample sample weighting amount (g).
Embodiment 2
(1) one three mouthfuls glass flask (100ml) A are fixed on magnetic stirring apparatus by iron clamp platform, three port a,
B, c add a cover plug with holes respectively.Dropping funel (100ml) B is inserted, in the plug of another two mouths in the plug of middle port b
Respectively insert a short glass tube.Separately prepare four 100ml conical flasks, add a cover the plug with diplopore, the glue of every conical flask respectively
Two glass tubes are inserted, a glass tube is slightly longer, and apart from bottom of bottle about 1cm, another glass tube is slightly short, apart from bottle stopper about in plug
1cm.Successively the long glass tube of each conical flask is connected with the short glass tube emulsion tube of another conical flask.Will with emulsion tube
The a mouth of there-necked flask A is connected with nitrogen cylinder (by pressure-reducing valve), c mouth is connected with the long glass tube of wherein conical flask,
The short tube of a conical flask C is communicated with air afterwards.
(2) weigh 5.0g NaOH, 48.9g barium chloride dihydrate in 1000mL bottle, add 1000mL to boil cooling
Water afterwards, shaking makes solid matter dissolve, and (barium ions concentration is 0.2mol/L, hydroxide ion to obtain final product barium hydroxide absorbing liquid
Concentration 0.12mol/L).
(3) accurately weighed 1.00135g 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, opens the b chewing-gum plug of flask A, by 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate sample
It is placed in bottom of bottle, add water 0.75ml, sample is moistened and mixes, put into a magnet rotor in bottle, be then reinstalled plug.
(4) add the sodium hydroxide solution 50mL of 0.5mol/L in conical flask C.By said apparatus connecting line, logical nitrogen
Gas 10 minutes, inspection system air-tightness.Accurately measure 150mL barium hydroxide absorbing liquid, be averagely placed in the other three cone in addition to C
In shape bottle, press said apparatus connecting line immediately.
(5) close the cock of dropping funel B, and be added thereto to 40ml sulfuric acid solution (0.5mol/L).Open dropping liquid leakage
Bucket cock, drips sulfuric acid solution with the speed of 4～5ml/min, adjusts nitrogen flow, makes every 2 in the conical flask being connected with flask A
A second bubble of emerging is advisable.As sulfuric acid solution residue about 5ml, close dropping funel cock, open magnetic agitation switch, continue
Continuous reaction 30 minutes.Reaction finishes, and closes magnetic agitation, closes nitrogen stream.
(6) merge absorbing liquid in three conical flasks and, in 250ml conical flask, add instructions phenolphthalein solution 1, use
0.5001mol/L HCI liquid is titrated to redness and disappears for terminal, titrating solution 26.82ml.Do blank a, titrating solution with method
36.16ml.Being calculated as follows carbonate content is 14.46%.Press dry product again and calculate carbonate content, this part of sample drying loses
Weigh 5.59%, conversion dry product carbonate content is 15.32%.
Carbonate content (%)=[(VEmpty-VSample) × C × 3.1]/W,
Wherein：VEmptyConsume titrating solution volume (ml) for blank；
VSampleFor sample consumption titrating solution volume (ml)；
C is titrating solution concentration (mol/L)；
W is test sample sample weighting amount (g).
Embodiment 3
(1) one three mouthfuls glass flask (100ml) A are fixed on magnetic stirring apparatus by iron clamp platform, three port a,
B, c add a cover plug with holes respectively.Dropping funel (100ml) B is inserted, in the plug of another two mouths in the plug of middle port b
Respectively insert a short glass tube.Separately prepare four 100ml conical flasks, add a cover the plug with diplopore, the glue of every conical flask respectively
Two glass tubes are inserted, a glass tube is slightly longer, and apart from bottom of bottle about 1cm, another glass tube is slightly short, apart from bottle stopper about in plug
1cm.Successively the long glass tube of each conical flask is connected with the short glass tube emulsion tube of another conical flask.Will with emulsion tube
The a mouth of there-necked flask A is connected with nitrogen cylinder (by pressure-reducing valve), c mouth is connected with the long glass tube of wherein conical flask,
The short tube of a conical flask C is communicated with air afterwards.
(2) weigh 5.0g NaOH, 48.9g barium chloride dihydrate in 1000mL bottle, add 1000mL to boil cooling
Water afterwards, shaking makes solid matter dissolve, and (barium ions concentration is 0.2mol/L, hydroxide ion to obtain final product barium hydroxide absorbing liquid
Concentration 0.12mol/L).
(3) accurately weighed 1.00157g 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, opens the b chewing-gum plug of flask A, by 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate sample
It is placed in bottom of bottle, add water 1.00ml, sample is moistened and mixes, put into a magnet rotor in bottle, be then reinstalled plug.
(4) add the sodium hydroxide solution 50mL of 0.5mol/L in conical flask C.By said apparatus connecting line, logical nitrogen
Gas 10 minutes, inspection system air-tightness.Accurately measure 150mL barium hydroxide absorbing liquid, be averagely placed in the other three cone in addition to C
In shape bottle, press said apparatus connecting line immediately.
(5) close the cock of dropping funel B, and be added thereto to 40ml sulfuric acid solution (0.5mol/L).Open dropping liquid leakage
Bucket cock, drips sulfuric acid solution with the speed of 4～5ml/min, adjusts nitrogen flow, makes every 2 in the conical flask being connected with flask A
A second bubble of emerging is advisable.As sulfuric acid solution residue about 5ml, close dropping funel cock, open magnetic agitation switch, continue
Continuous reaction 30 minutes.Reaction finishes, and closes magnetic agitation, closes nitrogen stream.
(6) merge absorbing liquid in three conical flasks and, in 250ml conical flask, add instructions phenolphthalein solution 1, use
0.5001mol/L HCI liquid is titrated to redness and disappears for terminal, titrating solution 26.90ml.Do blank a, titrating solution with method
36.15ml.Being calculated as follows carbonate content is 14.32%.Press dry product again and calculate carbonate content, this part of sample drying loses
Weigh 5.59%, conversion dry product carbonate content is 15.17%.
Carbonate content (%)=[(VEmpty-VSample) × C × 3.1]/W, wherein：VEmptyConsume titrating solution volume (ml) for blank；
VSampleFor sample consumption titrating solution volume (ml)；
C is titrating solution concentration (mol/L)；
W is test sample sample weighting amount (g).
Claims (7)
1. in a kind of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate the assay method of carbonate content it is characterised in that comprising the following steps：
(1) carbon dioxide is installed to produce and absorption plant；
(2) prepare barium hydroxide absorbent solution；
(3) precision weighs 1g 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, adds it in carbon dioxide generation device；
(4) add barium hydroxide absorbent solution in absorption plant；
(5) sulfuric acid is added to be reacted in the 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate described in step (3)；
(6) barium hydroxide absorbent solution is titrated with hydrochloric acid, calculated the content of carbonate in 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate.
2. in 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate according to claim 1 carbonate content assay method it is characterised in that：Step
(1), in, carbon dioxide produces and the installation steps of absorption plant are as follows：
Three mouthfuls of glass flask A are fixed on magnetic stirring apparatus, three ports a, b, c add a cover plug with holes respectively；Middle port b
Insert dropping funel B in plug, in the plug of another two mouths, respectively insert a short glass tube；Prepare four conical flasks, respectively plus
The plug of cover strip diplopore, inserts two different glass tubes of length respectively in the plug of every conical flask；Successively by each conical flask
Long glass tube be connected with the short glass tube emulsion tube of another conical flask；By a mouth of there-necked flask A with nitrogen cylinder even
Connect, c mouth is connected with the long glass tube of wherein conical flask, the short tube of last conical flask C is communicated with air.
3. in 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate according to claim 2 carbonate content assay method it is characterised in that：Step
(3) concrete operation step is as follows：
The accurately weighed 1g of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, opens the b chewing-gum plug of flask A, 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate sample is placed in bottom of bottle, adds water
0.5～1ml, sample is moistened and mixes, and puts into a magnet rotor, be then reinstalled plug in bottle.
4. in 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate according to claim 2 carbonate content assay method it is characterised in that：Step
(4) concrete operation step in is as follows：
The sodium hydroxide solution 50mL of 0.5mol/L is added in conical flask C；Connecting line, logical nitrogen 10 minutes, inspection system
Air-tightness；Accurately measure 150mL barium hydroxide absorbing liquid, be averagely placed in the other three conical flask in addition to C, connecting tube immediately
Road.
5. in 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate according to claim 2 carbonate content assay method it is characterised in that：Step
(5) concrete operation step is as follows：
Close the cock of dropping funel B, and be added thereto to the sulfuric acid solution of 40ml, 0.5mol/L；Open dropping funel cock,
Sulfuric acid solution is dripped with the speed of 4～5ml/min；As sulfuric acid solution residue about 5ml, close dropping funel cock, open magnetic
Power stirring switch, continues reaction 30 minutes；Reaction finishes, and closes magnetic agitation, closes nitrogen stream.
6. in 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate according to claim 1 carbonate content assay method it is characterised in that：Step
(2), in, the preparation steps of barium hydroxide absorbent solution are as follows：
Weigh 5.0g NaOH, 48.9g barium chloride dihydrate in 1000mL bottle, add 1000mL to boil the water after cooling,
Shaking obtains final product barium hydroxide absorbing liquid.
7. in 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate according to claim 1 carbonate content assay method it is characterised in that：Step
(6) concrete operation step is as follows：
Absorbing liquid in three conical flasks of merging, in 250ml conical flask, adds instructions phenolphthalein solution 1, uses 0.5mol/L hydrochloric acid
Titrating solution is titrated to redness and disappears for terminal；Do one with method blank；It is calculated as follows carbonate content；Calculate by dry product：
Carbonate content (%)=[(VEmpty-VSample) × C × 3.1]/W,
Wherein：VEmptyConsume titrating solution volume (ml) for blank；
VSampleFor sample consumption titrating solution volume (ml)；
C is titrating solution concentration (mol/L)；
W is test sample sample weighting amount (g).
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| CN114660229A (en) * | 2022-02-22 | 2022-06-24 | 山东合力泰化工有限公司 | Method and device for measuring content of organic compound in industrial ammonium nitrate |
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