CN102890086A - Method for determining sodium bicarbonate content in compound preparation - Google Patents
Method for determining sodium bicarbonate content in compound preparation Download PDFInfo
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- CN102890086A CN102890086A CN2012103979236A CN201210397923A CN102890086A CN 102890086 A CN102890086 A CN 102890086A CN 2012103979236 A CN2012103979236 A CN 2012103979236A CN 201210397923 A CN201210397923 A CN 201210397923A CN 102890086 A CN102890086 A CN 102890086A
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Abstract
The invention provides a method for determining sodium bicarbonate content in compound preparation, which comprises steps of preparing sodium bicarbonate negative solution according to buffer base in a compound preparation prescription; determining sodium bicarbonate negative solution, determining a compound preparation sample, counting the sodium bicarbonate content and the like; according to the invention, the preparation of the sodium bicarbonate negative solution is increased; the sodium bicarbonate negative solution is corrected through a determined value; the interference of the buffer base such as sodium lactate and the like at an aspect of a content result is removed; in addition, novel color developing agent use technology is used; phenolphthalein-cresol red-thymol blue indicator is added based on original methyl red-bromocresol green indicator; the content of sodium carbonate and the sodum bicarbonate can be determined synchronously through the judgment of two ending points; simultaneously, color change is improved from the gradual change process of an original method into the sudden change process of a novel method. According to the invention, a content determining method is characterized by simple operation; and a determined result is precise, effective and stable.
Description
Technical field
The present invention relates to the drug inspection field, be specifically related to a kind of method of measuring sodium bicarbonate content in the compound preparation.
Background technology
Sodium bicarbonate compound preparation of the prior art (being peritoneal dialysis solution), its solvent is water, contains sodium chloride, lime chloride, magnesium chloride, glucose, sodium lactate and sodium bicarbonate etc. in the prescription.According to national relevant regulations, should comprise the wherein assay experiment of various ion components in the quality standard of this compound preparation, but only have following a kind of method according to the content assaying method of sodium bicarbonate in the version Pharmacopoeia of the People's Republic of China sodium bicarbonate injection in 2010:
Precision measures this product an amount of (approximately being equivalent to sodium bicarbonate 0.5g), add water and be made into 50ml, methylate is red-and bromcresol green mixes 10 of indicator solutions, be titrated to solution with hydrochloric acid vs (0.5mol/L) and change aubergine into by green, boiled 2 minutes, let cool, continue to be titrated to solution and become mulberry by green.Every 1ml hydrochloric acid vs (0.5mol/L) is equivalent to the NaHCO of 42.00mg
3
The test findings of this content assaying method is as follows: 1. endpoint: endpoint was color cataclysm process when sodium bicarbonate solution used official method; And this compound preparation change color with this method titration the time is progressive formation, and terminal point is difficult for judging, and result precision is not high.2. content: feed intake according to preparation prescription 100%, and the method that adopts pharmacopeia to provide measures sample, only have sodium bicarbonate assay value higher, mean value reaches 103%.
Analyzing reason mainly is:
1. because this product is compound preparation, except containing sodium bicarbonate, also have the compositions such as sodium lactate, glucose, so aspect change color, affect to some extent.
2. contain the buffer base (BB)s such as sodium lactate in the prescription, sodium lactate is weak acid strong alkali salt, can consume a certain amount of hydrochloric acid when titration, causes the measured value result higher.
Summary of the invention
For measuring the defects that the sodium bicarbonate content method exists in the prior art, the invention provides a kind of method of measuring sodium bicarbonate content in the compound preparation, detection method of the present invention is mainly used in containing simultaneously in the compound preparation buffer base (BB)s such as lactate, and these buffer base (BB)s use when generation is disturbed to the sodium bicarbonate assay.
For achieving the above object, the present invention adopts following technical proposals to be achieved:
A kind of method of measuring sodium bicarbonate content in the compound preparation, it comprises following detecting step:
(1) prepares the negative solution of sodium bicarbonate according to the concentration of one or more buffer base (BB)s in the compound preparation prescription; With hydrochloric acid vs titration compound preparation to be measured, according to the buffer base (BB) and the concentration of sodium bicarbonate and the concentration that sampling amount is determined the hydrochloric acid vs that consume hydrochloric acid in the compound preparation;
(2) measure the negative solution of sodium bicarbonate: precision measures the negative liquor capacity V of described sodium bicarbonate
Negative, methylate is red-bromcresol green indicator 5-30 drips, and uses to be titrated to solution with the hydrochloric acid vs that detects the testing sample same concentrations and to become mulberry by green, and read volume this moment is V
0
(3) measure sodium bicarbonate content in the compound preparation: precision measures the compound preparation volume V that is equivalent to sodium bicarbonate 15-20mg
To be measured, then thin up adds 4-6 and drips phenolphthalein-cresol red-thymol blue indicator, is titrated to misty rose with the hydrochloric acid vs of described same concentrations and is close to the colourless terminal point that is, and reading volume is V
1
Again methylate red-bromcresol green indicator 5-30 drips, and when continuing to be titrated to solution and to change aubergine into by green with described hydrochloric acid vs, boils, and is cooled to room temperature, continues to be titrated to solution and becomes mulberry by green, is terminal point, reading volume at this moment is V
2The computing formula of sodium bicarbonate content is in the described compound preparation:
C
HClRepresent the concentration of hydrochloric acid vs.
To further improvement in the technical proposal: the negative solution concentration of described sodium bicarbonate equals buffer base (BB) concentration in the compound preparation prescription.
To further improvement in the technical proposal: the volume ratio of described phenolphthalein-cresol red-thymol blue is 1:1:3.
To further improvement in the technical proposal: described hydrochloric acid vs concentration is 0.005-0.5mol/L.
To further improvement in the technical proposal: described buffer base (BB) is one or more in lactate, acetonate, citrate, isocitrate, aconitase, ketoglutarate, succinate, fumarate, malate or the oxaloacetate.
To further improvement in the technical proposal: the negative liquor capacity V of described sodium bicarbonate
NegativeBe 20-80ml.
Compared with prior art, advantage of the present invention and good effect are:
The present invention has increased the preparation of the negative solution of sodium bicarbonate, and by measured value sodium bicarbonate content is proofreaied and correct, and has removed the interference of the buffer base (BB)s such as sodium lactate aspect content results; And, adopted new developer operational version, increased phenolphthalein-cresol red-thymol blue (volume ratio is 1:1:3) indicator on the basis of original methyl red-bromcresol green indicator, can measure simultaneously the content of sodium carbonate and sodium bicarbonate by the judgement of two terminal points, change color is improved as the cataclysm process of new method by the progressive formation of former method simultaneously.Content assaying method of the present invention is simple to operate, records the result accurate, and is effectively, stable.
Embodiment
Below in conjunction with embodiment technical scheme of the present invention is described in further detail.
Embodiment 1
The detection method of sodium bicarbonate of the present invention is described as an example of following compound preparation example, described compound preparation contains the composition that can consume the hydrochloric acid titer, buffer base (BB) described in the present invention is the composition of the consumption hydrochloric acid except sodium bicarbonate in the compound preparation, and described buffer base (BB) is generally one or more in lactate, acetonate, citrate, isocitrate, aconitase, ketoglutarate, succinate, fumarate, malate or the oxaloacetate.Contain in the negative solution of described sodium bicarbonate with compound preparation in identical buffer base (BB) composition and concentration except sodium bicarbonate.
The described detection method of the present embodiment is for detection of the content of sodium bicarbonate in the compound preparation that contains sodium lactate.Certain detection method of the present invention also is applicable to contain the compound preparation of the multiple buffer base (BB)s such as sodium lactate.
Described compound preparation specification: 1.5% glucose 2000ml(725 ︰ 1275);
2.5% glucose 2000ml(725 ︰ 1275);
4.25% glucose 2000ml(725 ︰ 1275).
It is that pack two Room that described compound preparation is divided into, and wherein A liquid is 725ml, and B liquid is 1275ml.
[prescription] is as follows:
A liquid
B liquid
The method of sodium bicarbonate content comprises following operation steps in the mensuration compound preparation of the present invention:
1, the negative solution of preparation sodium bicarbonate and hydrochloric acid vs
Buffer base (BB) composition in the compound preparation to be measured of the present invention is sodium lactate, the sodium bicarbonate negative solution identical according to the concentration compound concentration of sodium lactate in the described compound preparation prescription, extracting lactic acid sodium 0.26g, place the 100ml measuring bottle, thin up shakes up to scale, and get final product.If contain multiple buffer base (BB) in the compound preparation, then prepare the negative solution of sodium bicarbonate according to the total amount of multiple buffer base (BB) in the compound preparation.
According to the buffer base (BB) and the concentration of sodium bicarbonate and the concentration that sampling amount is determined the hydrochloric acid vs that consume hydrochloric acid in the compound preparation to be measured.If hydrochloric acid vs concentration is too large, cause the hydrochloric acid vs volume that uses too little, reading error is too large; If the hydrochloric acid vs concentration of using is too little, cause the hydrochloric acid vs volume that uses too large, consumption is too large, cause the waste of material and the reduction of work efficiency, so situation according to concrete testing sample, determine the concentration of hydrochloric acid vs, the concentration through testing definite hydrochloric acid vs in the present embodiment is 0.01mol/L.
2, measure the negative solution of sodium bicarbonate
Precision measures the negative solution 50ml of described sodium bicarbonate, place conical flask, methylate is red-bromcresol green indicator (compound method such as Chinese Pharmacopoeia 2010, appendix XV E methyl red-bromcresol green mixing indicator solution) 20, be titrated to solution with described hydrochloric acid vs (0.01mol/L) and become mulberry by green, read volume this moment is V
0Milliliter.V
0Represent that sodium lactate is on the impact of sodium bicarbonate in the compound preparation, sodium lactate is weak acid strong alkali salt, belongs to a kind of in the buffer base (BB), and it is alkalescence in aqueous solution, so also will consume certain hydrochloric acid vs volume in the process of titration.If do not get rid of sodium lactate to the interference of sodium bicarbonate assay, can make sodium bicarbonate assay value higher.
3, measure the content of testing sample sodium bicarbonate: precision measures the B liquid 5ml of described compound preparation, place conical flask, thin up makes into 50ml, the purpose of thin up is to prevent that the later stage is by evaporate to dryness, add 4～6 phenolphthalein-cresol red-thymol blues (1:1:3) indicator, be titrated to misty rose with hydrochloric acid vs (0.01mol/L) and be close to the colourless terminal point that is, recording volume is V
1Milliliter.If V
1Non-vanishing, illustrating has sodium carbonate in the solution, the quality existing problems of compound preparation, and therefore, detection method of the present invention also can be for detection of the quality problems of product.V in the present embodiment
1Be zero, illustrate in the solution without sodium carbonate, if but quality is unstable, and sodium bicarbonate can generate sodium carbonate, and the generation of sodium carbonate has a direct impact the quality of this product.
For ease of observing, conical flask underneath one white plaque is made background, again methylate red-the about 1ml of bromcresol green indicator, when continuing to be titrated to solution and to change aubergine into by green with the hydrochloric acid vs, boiled 2 minutes, and be cooled to room temperature, continue to be titrated to solution and become mulberry by green, be terminal point, read volume this moment is the V2 milliliter.Every 1ml hydrochloric acid vs (0.01mol/L) is equivalent to the NaHCO of 0.84mg
3Sodium bicarbonate cubage formula is as follows in the present embodiment:
C in the above-mentioned formula
HClRepresent the concentration of hydrochloric acid vs, 84 represent sodium bicarbonate molecular weight, V
0Represent the volume that sodium lactate consumes the hydrochloric acid vs, can eliminate sodium lactate to the impact of sodium bicarbonate when calculating sodium bicarbonate content.
V
1Representative generates sodium carbonate, the hydrochloric acid vs volume that sodium carbonate consumes such as sodium bicarbonate in the sample solution.If have sodium carbonate in this compound preparation then unfavorable to the quality of product.
V
2All buffer base (BB)s and sodium bicarbonate consume the volume of hydrochloric acid vs in the representative sample solution.
C in the present embodiment
HClBe 0.01034mol/L, V
0Be 9.68ml, V
1Be 0, V
2Be 20.04ml, V
NegativeBeing 5mL, is 3.31g/mL through calculating sodium bicarbonate content, and indicating content is 100.6%.
According to detection method of the present invention the multiple sodium salt compound preparation that contains simultaneously the materials such as lime chloride, magnesium chloride is carried out verification experimental verification, the method is all applicable as a result.Show thus, this method is applicable to contain simultaneously the identification of sodium salt in the Multicomponent Complex Preparations such as sodion, calcium ion, magnesium ion.
Above embodiment is only in order to illustrating technical scheme of the present invention, but not limits it; Although with reference to previous embodiment the present invention is had been described in detail, for the person of ordinary skill of the art, still can make amendment to the technical scheme that previous embodiment is put down in writing, perhaps part technical characterictic wherein is equal to replacement; And these modifications or replacement do not make the essence of appropriate technical solution break away from the spirit and scope of the present invention's technical scheme required for protection.
Claims (6)
1. method of measuring sodium bicarbonate content in the compound preparation is characterized in that it comprises following detecting step:
(1) prepares the negative solution of sodium bicarbonate according to the concentration of one or more buffer base (BB)s in the compound preparation prescription; With hydrochloric acid vs titration compound preparation to be measured, according to the buffer base (BB) and the concentration of sodium bicarbonate and the concentration that sampling amount is determined the hydrochloric acid vs that consume hydrochloric acid in the compound preparation;
(2) measure the negative solution of sodium bicarbonate: precision measures the negative liquor capacity V of described sodium bicarbonate
Negative, methylate is red-bromcresol green indicator 5-30 drips, and uses to be titrated to solution with the hydrochloric acid vs that detects the testing sample same concentrations and to become mulberry by green, and read volume this moment is V
0
(3) measure sodium bicarbonate content in the compound preparation: precision measures the compound preparation volume V that is equivalent to sodium bicarbonate 15-20mg
To be measured, then thin up adds 4-6 and drips phenolphthalein-cresol red-thymol blue indicator, is titrated to misty rose with the hydrochloric acid vs of described same concentrations and is close to the colourless terminal point that is, and reading volume is V
1
Again methylate red-bromcresol green indicator 5-30 drips, and when continuing to be titrated to solution and to change aubergine into by green with described hydrochloric acid vs, boils, and is cooled to room temperature, continues to be titrated to solution and becomes mulberry by green, is terminal point, reading volume at this moment is V
2The computing formula of sodium bicarbonate content is in the described compound preparation:
C
HClRepresent the concentration of hydrochloric acid vs.
2. the assay method of sodium bicarbonate content in a kind of compound preparation according to claim 1 is characterized in that: the negative solution concentration of described sodium bicarbonate equals buffer base (BB) concentration in the compound preparation prescription.
3. the assay method of sodium bicarbonate content in a kind of compound preparation according to claim 1 and 2, it is characterized in that: the volume ratio of described phenolphthalein-cresol red-thymol blue is 1:1:3.
4. the assay method of sodium bicarbonate content in a kind of compound preparation according to claim 1, it is characterized in that: described hydrochloric acid vs concentration is 0.005-0.5mol/L.
5. the assay method of sodium bicarbonate content in a kind of compound preparation according to claim 1, it is characterized in that: described buffer base (BB) is one or more in lactate, acetonate, citrate, isocitrate, aconitase, ketoglutarate, succinate, fumarate, malate or the oxaloacetate.
6. the assay method of sodium bicarbonate content in a kind of compound preparation according to claim 1 is characterized in that: the negative liquor capacity V of described sodium bicarbonate
NegativeBe 20-80ml.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104458732A (en) * | 2014-12-15 | 2015-03-25 | 内蒙古包钢钢联股份有限公司 | Method for calibrating hydrochloric acid and sulfuric acid standard liquids by adopting sodium carbonate reference |
| CN108196001A (en) * | 2018-03-28 | 2018-06-22 | 重庆市食品药品检验检测研究院 | A kind of assay method of carbonate content in injection cephalosporin analog antibiotic |
| CN109115939A (en) * | 2018-09-29 | 2019-01-01 | 大丰跃龙化学有限公司 | A kind of method of quick measurement cyclopropyl amine content |
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| RO109126B1 (en) * | 1990-09-24 | 1994-11-30 | Letitia Nemes | Humidity rapid determination method in raw sodium bicarbonate, intermediary product which is resulting from the calcinated soda ammoniacal preparation process |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104458732A (en) * | 2014-12-15 | 2015-03-25 | 内蒙古包钢钢联股份有限公司 | Method for calibrating hydrochloric acid and sulfuric acid standard liquids by adopting sodium carbonate reference |
| CN108196001A (en) * | 2018-03-28 | 2018-06-22 | 重庆市食品药品检验检测研究院 | A kind of assay method of carbonate content in injection cephalosporin analog antibiotic |
| CN109115939A (en) * | 2018-09-29 | 2019-01-01 | 大丰跃龙化学有限公司 | A kind of method of quick measurement cyclopropyl amine content |
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