CN103472103A - Internal standard solution reagent for assaying electrolyte for fully-automatic biochemical analyzer and preparation method thereof - Google Patents
Internal standard solution reagent for assaying electrolyte for fully-automatic biochemical analyzer and preparation method thereof Download PDFInfo
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- CN103472103A CN103472103A CN2013104388134A CN201310438813A CN103472103A CN 103472103 A CN103472103 A CN 103472103A CN 2013104388134 A CN2013104388134 A CN 2013104388134A CN 201310438813 A CN201310438813 A CN 201310438813A CN 103472103 A CN103472103 A CN 103472103A
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Abstract
The invention relates to an internal standard solution reagent for assaying an electrolyte for a fully-automatic biochemical analyzer. The internal standard solution reagent comprises at least one buffer solution, at least one inorganic or organic acid and at least two inorganic salts, wherein the concentration of the buffer solution in the reagent is 30-50mmol/L, the percentage of the inorganic or organic acid by weight in the reagent is 0.5-1%, and the concentration of the inorganic salts in the reagent is 0.1-5mmol/L. Preferably, the buffer solution is a Bis-Tris buffer solution, the inorganic acid is boric acid or acetic acid, and the two inorganic salts are potassium dihydrogen phosphate and sodium bicarbonate or potassium dihydrogen phosphate and potassium bicarbonate. The internal standard solution reagent for assaying the electrolyte, disclosed by the invention, has the characteristics that the accuracy of clinical item testing is good, the service life of a selective electrode film is prolonged, and the like; meanwhile, all the ingredients of the reagent disclosed by the invention are biodegradable and have no potential contamination for environment, so that the requirements for environmental friendliness are met.
Description
Technical field
The present invention relates to internal standard liquid reagent for a kind of electrolyte analysis, relate in particular to a kind of diagnostic reagent used when analyzing samples (comprising serum, blood plasma, urine, cerebrospinal fluid etc.) the intermediate ion concentration for automatic clinical chemistry analyzer and preparation method thereof.
Background technology
The electrolyte of body fluid plays very important effect in human body.Potassium ion is the topmost kation of intracellular fluid, and sodion is the topmost kation of extracellular fluid, and chlorion is the topmost negative ion in extracellular, safeguards that osmotic pressure keeps acid base equilibrium etc. to play an important role.The electrolytical test accuracy of automatic clinical chemistry analyzer directly affects doctor's diagnostic result, therefore effectively controls the factor that automatic clinical chemistry analyzer affects measurement result in test process, guarantees that the accuracy of each measurement result is particularly important.
In electrolytes determined reagent, the effect of internal standard liquid is the correcting system current potential, current potential when guaranteeing sample to be tested by electrodes selective film surface accurately, and within the very short time, make electrodes selective film surface can fully restPose to guarantee the mensuration of next sample.The effect of internal standard liquid not only will guarantee in the very short time to make electrodes selective film surface can fully restPose to guarantee that the mensuration of next sample is accurate, and require zero load to electrodes selective film surface, so its ionic species, the adjusting of the control of ion concentration and reagent osmotic pressure for the daily servicing of automatic clinical chemistry analyzer electrolytes determined part, guarantee that test accuracy is extremely important.
At present, automatic clinical chemistry analyzer is surging year by year in the quantity that has of China, and sizable scale has been arranged.In actual clinical examination activity, the automatic clinical chemistry analyzer of import brand is come out top, and its electrolysis special matter reagent is also to depend on for a long time imported product, makes testing cost high.Although the production and supply of very few minority electrolyte reagent are also arranged domestic, and practical application effect is all undesirable, so a lot of product still can't meet user's demand.
The object of the invention is to invention for automatic clinical chemistry analyzer electrolytes determined internal standard liquid, load to electrolyte electrodes selective film is low, cost is low, alternative similar imported product, internal standard liquid and compound method thereof for the automatic clinical chemistry analyzer electrolytes determined that meets the clinical examination needs.
Summary of the invention
The objective of the invention is for the deficiencies in the prior art, internal standard liquid reagent and preparation method thereof for a kind of electrolytes determined for automatic clinical chemistry analyzer is provided.
The present invention has adopted following technical scheme:
Internal standard liquid reagent for a kind of electrolytes determined for automatic clinical chemistry analyzer, described internal standard liquid reagent comprises: at least one damping fluid, at least one mineral acid or organic acid, at least two kinds of inorganic salts, wherein said each composition shared concentration and weight percent content in reagent are respectively:
Damping fluid: 30-50mmol/L;
Mineral acid or organic acid: 0.5～1%;
Inorganic salts: 0.1～5mmol/L.
Preferably, described damping fluid is the Bis-Tris damping fluid.Described mineral acid is boric acid or acetic acid.Described two kinds of inorganic salts are potassium dihydrogen phosphate, sodium bicarbonate or potassium dihydrogen phosphate, saleratus.
The present invention also comprises the preparation method of a kind of electrolytes determined for automatic clinical chemistry analyzer with internal standard liquid reagent, and it comprises the steps:
(1) get the 700mL pure water with graduated cylinder, then toward the Bis-Tris damping fluid that wherein slowly adds 3-6g dissolve and the rear immigration 1L volumetric flask that stirs in;
(2) slowly add boric acid or the acetic acid of 5mL, potassium dihydrogen phosphate 10-20mg, sodium bicarbonate or saleratus 100-150mg, constant volume stirs after being 1L, obtains the internal standard liquid reagent for electrolytes determined of 1 liter of stable automatic clinical chemistry analyzer.
Embodiment:
Below in conjunction with specific embodiment to the present invention to further elaboration.
Embodiment 1: at first with graduated cylinder, get the 700mL pure water, then toward the Bis-Tris buffering agent that wherein slowly adds 3g dissolve and the rear immigration 1L volumetric flask that stirs in.Then slowly add the boric acid of 5mL, potassium dihydrogen phosphate 10mg, after sodium bicarbonate 150mg constant volume is 1L, stir, and obtains internal standard liquid reagent for 1 liter of stable automatic clinical chemistry analyzer electrolytes determined.
By the performance of the above-mentioned internal standard liquid of Hitachi, Ltd's 7600 automatic clinical chemistry analyzer electrolyte module testing reagent, correlativity of measurement result etc. when test index has Clinical Project to criticize interior repeatability, the range of linearity, the former installed reagents of use.
In test result, the all properties test index all the test controlled target zone in: sodion, chlorion batch in repeatability all in 2%, repeated SD<the 0.1mmol/L of potassium ion, the range of linearity of serum sample is respectively: K:1.5-10mmol/L, Na:80-180mmol/L, Cl:60-120mmol/L.With the related coefficient of former installed reagents measurement result all 0.9800, in dependent equation slope 1.00 ± 0.01.
Embodiment 2: at first with graduated cylinder, get the 700mL pure water, then toward the Bis-Tris buffering agent that wherein slowly adds 6g dissolve and the rear immigration 1L volumetric flask that stirs in.Then slowly add the boric acid of 5mL, potassium dihydrogen phosphate 20mg, after sodium bicarbonate 100mg constant volume is 1L, stir, and obtains internal standard liquid reagent for 1 liter of stable automatic clinical chemistry analyzer electrolytes determined.
By the performance of the above-mentioned internal standard liquid of Hitachi, Ltd's 7600 automatic clinical chemistry analyzer electrolyte module testing reagent, correlativity of measurement result etc. when test index has Clinical Project to criticize interior repeatability, the range of linearity, the former installed reagents of use.
In test result, the all properties test index all the test controlled target zone in: sodion, chlorion batch in repeatability all in 2%, repeated SD<the 0.1mmol/L of potassium ion, the range of linearity of serum sample is respectively: K:1.5-10mmol/L, Na:80-180mmol/L, Cl:60-120mmol/L.With the related coefficient of former installed reagents measurement result all 0.9800, in dependent equation slope 1.00 ± 0.01.
Embodiment 3: at first with graduated cylinder, get the 700mL pure water, then toward the Bis-Tris buffering agent that wherein slowly adds 3g dissolve and the rear immigration 1L volumetric flask that stirs in.Then slowly add the acetic acid of 5mL, potassium dihydrogen phosphate 10mg, after sodium bicarbonate 150mg constant volume is 1L, stir, and obtains internal standard liquid reagent for 1 liter of stable automatic clinical chemistry analyzer electrolytes determined.
By the performance of the above-mentioned internal standard liquid of Hitachi, Ltd's 7600 automatic clinical chemistry analyzer electrolyte module testing reagent, correlativity of measurement result etc. when test index has Clinical Project to criticize interior repeatability, the range of linearity, the former installed reagents of use.
In test result, the all properties test index all the test controlled target zone in: sodion, chlorion batch in repeatability all in 2%, repeated SD<the 0.1mmol/L of potassium ion, the range of linearity of serum sample is respectively: K:1.5-10mmol/L, Na:80-180mmol/L, Cl:60-120mmol/L.With the related coefficient of former installed reagents measurement result all 0.9800, in dependent equation slope 1.00 ± 0.01.
Embodiment 4: at first with graduated cylinder, get the 700mL pure water, then toward the Bis-Tris buffering agent that wherein slowly adds 6g dissolve and the rear immigration 1L volumetric flask that stirs in.Then slowly add the acetic acid of 5mL, potassium dihydrogen phosphate 20mg, after sodium bicarbonate 100mg constant volume is 1L, stir, and obtains internal standard liquid reagent for 1 liter of stable automatic clinical chemistry analyzer electrolytes determined.
By the performance of the above-mentioned internal standard liquid of Hitachi, Ltd's 7600 automatic clinical chemistry analyzer electrolyte module testing reagent, correlativity of measurement result etc. when test index has Clinical Project to criticize interior repeatability, the range of linearity, the former installed reagents of use.
In test result, the all properties test index all the test controlled target zone in: sodion, chlorion batch in repeatability all in 2%, repeated SD<the 0.1mmol/L of potassium ion, the range of linearity of serum sample is respectively: K:1.5-10mmol/L, Na:80-180mmol/L, Cl:60-120mmol/L.With the related coefficient of former installed reagents measurement result all 0.9800, in dependent equation slope 1.00 ± 0.01.
Embodiment 5: at first with graduated cylinder, get the 700mL pure water, then toward the Bis-Tris buffering agent that wherein slowly adds 3g dissolve and the rear immigration 1L volumetric flask that stirs in.Then slowly add the boric acid of 5mL, potassium dihydrogen phosphate 10mg, after saleratus 150mg constant volume is 1L, stir, and obtains internal standard liquid reagent for 1 liter of stable automatic clinical chemistry analyzer electrolytes determined.
By the performance of the above-mentioned internal standard liquid of Hitachi, Ltd's 7600 automatic clinical chemistry analyzer electrolyte module testing reagent, correlativity of measurement result etc. when test index has Clinical Project to criticize interior repeatability, the range of linearity, the former installed reagents of use.
In test result, the all properties test index all the test controlled target zone in: sodion, chlorion batch in repeatability all in 2%, repeated SD<the 0.1mmol/L of potassium ion, the range of linearity of serum sample is respectively: K:1.5-10mmol/L, Na:80-180mmol/L, Cl:60-120mmol/L.With the related coefficient of former installed reagents measurement result all 0.9800, in dependent equation slope 1.00 ± 0.01.
Embodiment 6: at first with graduated cylinder, get the 700mL pure water, then toward the Bis-Tris buffering agent that wherein slowly adds 6g dissolve and the rear immigration 1L volumetric flask that stirs in.Then slowly add the acetic acid of 5mL, potassium dihydrogen phosphate 20mg, after saleratus 100mg constant volume is 1L, stir, and obtains internal standard liquid reagent for 1 liter of stable automatic clinical chemistry analyzer electrolytes determined.
By the performance of the above-mentioned internal standard liquid of Hitachi, Ltd's 7600 automatic clinical chemistry analyzer electrolyte module testing reagent, correlativity of measurement result etc. when test index has Clinical Project to criticize interior repeatability, the range of linearity, the former installed reagents of use.
In test result, the all properties test index all the test controlled target zone in: sodion, chlorion batch in repeatability all in 2%, repeated SD<the 0.1mmol/L of potassium ion, the range of linearity of serum sample is respectively: K:1.5-10mmol/L, Na:80-180mmol/L, Cl:60-120mmol/L.With the related coefficient of former installed reagents measurement result all 0.9800, in dependent equation slope 1.00 ± 0.01.
Automatic clinical chemistry analyzer electrolytes determined provided by the invention is with also contain a certain amount of inorganic salts, mineral acid or organic acid in internal standard liquid reagent except containing a large amount of damping fluids.Wherein: the effect of the pH value of the condition internal standard liquid buffer system of mineral acid/organic acid in this agent makes reagent be not easy to be subject to sample pH impact.The use of inorganic salts in addition, in the ion concentration kept as much as possible, incorporate in buffer system, guaranteed that the osmotic pressure of internal standard liquid remains in 60mOsm/L.
The present invention is applicable to automatic clinical chemistry analyzer, is particularly useful for the automatic clinical chemistry analyzer of Hitachi/Roche brand.Can meet the requirement of clinical examination work, with original-pack similar imported product, equal cleaning performance relatively be arranged, accurately it is reproducible for the testing result of sample.
Finally it should be noted that, above embodiment is only in order to describe technical scheme of the present invention rather than the technical program is limited, the present invention can extend to other modification, variation, application and embodiment in application, and therefore thinks that all such modifications, variation, application, embodiment are in spirit of the present invention and teachings.
Claims (6)
1. internal standard liquid reagent for the electrolytes determined for automatic clinical chemistry analyzer, described internal standard liquid reagent comprises: at least one damping fluid, at least one mineral acid or organic acid, at least two kinds of inorganic salts, wherein said each composition shared concentration and weight percent content in reagent are respectively:
Damping fluid: 30-50mmol/L;
Mineral acid or organic acid: 0.5～1%;
Inorganic salts: 0.1～5mmol/L.
2. internal standard liquid reagent according to claim 1, it is characterized in that: described damping fluid is the Bis-Tris damping fluid.
3. internal standard liquid reagent according to claim 1 and 2, it is characterized in that: described mineral acid is boric acid or acetic acid.
4. internal standard liquid reagent according to claim 1 and 2, it is characterized in that: described two kinds of inorganic salts are potassium dihydrogen phosphate, sodium bicarbonate or potassium dihydrogen phosphate, saleratus.
5. internal standard liquid reagent according to claim 4, it is characterized in that: described two kinds of inorganic salts are potassium dihydrogen phosphate, sodium bicarbonate or potassium dihydrogen phosphate, saleratus.
6. the preparation method of the use of the electrolytes determined for an automatic clinical chemistry analyzer internal standard liquid reagent, is characterized in that the method comprises the steps:
(1) get the 700mL pure water with graduated cylinder, then toward the Bis-Tris damping fluid that wherein slowly adds 3-6g dissolve and the rear immigration 1L volumetric flask that stirs in;
(2) slowly add boric acid or the acetic acid of 5mL, potassium dihydrogen phosphate 10-20mg, sodium bicarbonate or saleratus 100-150mg, constant volume stirs after being 1L, obtains the internal standard liquid reagent for electrolytes determined of 1 liter of stable automatic clinical chemistry analyzer.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114544734A (en) * | 2021-12-02 | 2022-05-27 | 浙江鑫科医疗科技有限公司 | Reagent matched with electrolyte module of Beckmann AU series analyzer |
| CN114839240A (en) * | 2021-02-01 | 2022-08-02 | 北京百龙腾(武汉)科贸有限公司 | Formaldehyde-free electrode method clinical electrolyte measuring reagent |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002005873A (en) * | 2000-06-27 | 2002-01-09 | Matsushita Electric Ind Co Ltd | INTEGRAL pH SENSOR |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002005873A (en) * | 2000-06-27 | 2002-01-09 | Matsushita Electric Ind Co Ltd | INTEGRAL pH SENSOR |
Non-Patent Citations (2)
| Title |
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| 曹永坚等: "日立7170生化分析仪离子选择电极内标液的研制与应用", 《检验医学》, vol. 24, no. 11, 30 November 2009 (2009-11-30), pages 797 * |
| 罗强等: "日立系列生化分析仪ISE模块配套试剂的研制与应用", 《实用医学杂志》, vol. 25, no. 18, 31 December 2009 (2009-12-31), pages 3139 - 3141 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114839240A (en) * | 2021-02-01 | 2022-08-02 | 北京百龙腾(武汉)科贸有限公司 | Formaldehyde-free electrode method clinical electrolyte measuring reagent |
| CN114839240B (en) * | 2021-02-01 | 2024-02-13 | 北京百龙腾(武汉)科贸有限公司 | Electrode method clinical electrolyte measuring reagent without formaldehyde |
| CN114544734A (en) * | 2021-12-02 | 2022-05-27 | 浙江鑫科医疗科技有限公司 | Reagent matched with electrolyte module of Beckmann AU series analyzer |
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Application publication date: 20131225 |