CN109916891A - A kind of dry chemistry reagent piece and preparation method thereof quantitative determining uric acid concentration - Google Patents
A kind of dry chemistry reagent piece and preparation method thereof quantitative determining uric acid concentration Download PDFInfo
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Abstract
The present invention relates to clinical in vitro diagnosis in vitro reagent technique field, in particular to a kind of dry chemistry reagent piece and preparation method thereof for quantitative determining uric acid concentration.The dry chemistry reagent piece includes four laminations, is followed successively by support layer, color layer, reagent layer and diffusion layer；Reagent in reagent layer includes buffer system, hydrophilic colloid, uricase, peroxidase, chelating agent, activator；Reagent in color layer includes chromogen, hydrophilic colloid and surfactant.Compared with prior art, the invention has the following advantages that operating process is simple, pattern detection is directly added dropwise without preparing in reagent；Analoids dry no moisture, and analoids have good stability；Diffusion layer has filtering function, and the endogenous such as haemolysis, bilirubin and ascorbic acid interference sample does not significantly interfere with measurement result；Testing result is reproducible, accuracy is high, can carry out quantitative detection, and the range of linearity is wide；Preparation process is easy, and easy to operate, harmfulness, pollution are small.
Description
Technical field
The present invention relates to clinical in vitro diagnosis in vitro reagent technique field, in particular to a kind of desiccation for quantitative determining uric acid concentration
Learn analoids and preparation method thereof.
Background technique
Uric acid is the main metabolites of birds and reptiles, is slightly soluble in water, easily formation crystal.It is produced in normal human's urine
Object is mainly urea, contains a small amount of uric acid.Uric acid is the final product of purine metabolism, is three oxygroup purine, and alcohol of formula is weakly acidic.Respectively
The uric acid generated after kind purine oxidation is excreted with urine.
Under normal circumstances, about 1200 milligrams of intracorporal uric acid, newly-generated about 600 milligrams daily, while draining 600
Milligram, the state in balance.But if generation in vivo excessively has little time excretion or uric acid excretion mechanism is degenerated, then urinate in vivo
Acid is detained excessive, when blood uric acid concentration is greater than 7 milligrams/deciliter, leads to human body fluid souring, influences the normal function of human body cell
Can, gout will be caused for a long time by ignoring.In addition the excessively insufficient metabolism relative delay that also can lead to of fatigue or rest causes
Gout morbidity.
Uric acid is all from glomerular filtration in blood, wherein 98% in proximal convoluted tubule middle section to be secreted into glomerulus again intracavitary,
Then it is intracavitary in proximal convoluted tubule middle section to be secreted into renal tubule again for 50% re-absorbed uric acid, has 40% again in proximal convoluted tubule straight section
~44% by reabsorption, the discharge of only 6%~10% uric acid.The generation of uric acid and drainage rate are more constant in normal human.Body
Uric acid content changes in liquid, can sufficiently reflect the situation of the functions such as human body metabolism, immune.
Clinical research shows increasing for uric acid, directly has directly with patients such as gout, hypertension, hyperlipidemia, diabetes
Relationship, uric acid increases closely related with atherosclerotic cardiovascular disease risk, and uric acid often increases 1 μm of ol/L, male
12% and 37% are increased respectively with Women with Coronary Heart Disease event risk.Uric acid increase it is not only related to cardiovascular risk, also and glycosuria
The onset risk of patient's microvascular complication is closely related.Uric acid increase may be retina hard exudate and maculopathy,
The important pathogenic factor of proliferative retinopathy, and retinopathy severity is positively correlated with uric acid level.By facing
Bed test, Uric Acid Content and urine uric acid content, under normal circumstances, there is certain correlations.And blood uric acid at this stage
Higher number is in significant ascendant trend, therefore the content for detecting uric acid in blood has very important meaning to clinical diagnosis
Justice.
The method of measurement uric acid can be divided into two methods of liquid reagent and dry chemistry reagent by types of agents at present.Liquid examination
The detection method of agent mainly has spectrophotometry, Optical Rotation, gas chromatography, high performance liquid chromatography etc..These methods pair
Uric acid concentration carries out detection and needs specific equipment, and equipment itself costly, does not have economy；Professional technique is needed simultaneously
The talent operates instrument, does not have due universality.The method measurement period is long, and analytic process is complex, cannot achieve uric acid
The real time measure.
Dry chemistry reagent is mainly used in emergency treatment, on-site test.With easy, quickly, flexibly and be not necessarily to professional
The advantages that operation.Domestic at present to be essentially qualitative or semiquantitative determination, this dry chemistry reagent piece is by filter paper, cellulose
The one kind such as piece, porous glue film multilayer material whole reagents fixed in advance, two layers and three layers by the processing such as stacking, bonding, punching press
In conjunction with.It is little to measure the range of linearity, encountering has using meeting interference experiment result under drug condition.There are many examinations in analysis test
Agent cannot be pre-mixed, and complicated test fluid needs to pre-process, and which limits dry chemistry reagent piece application fields.Quantitative inspection
The dry chemistry reagent card of survey is all external production.Using Johson & Johnson and company, Fuji as the multilayer dry slides method of representative, sense is utilized
The reagents such as reagent layer, auxiliary reagent layer, optical diffusion layer and distribution layer are coated in transparent support layer by the coating technology of ray film,
From the variation of the reverse side of support layer measurement optical density.Though above-mentioned dry chemistry reagent piece can quantitative detection, distribution layer or diffusion layer
Organic reagent need to be used, requires material installation high, production technology complexity, and very harmful to preparation personnel health, pollution
Environment.
Summary of the invention
In view of this, the present invention provides a kind of dry chemistry reagent pieces and preparation method thereof for quantitative determining uric acid concentration.
The dry chemistry reagent piece testing result accuracy is high, and precision is good, and stability is good, and long shelf-life is easy to operate, the scope of application
Extensively.
In order to achieve the above-mentioned object of the invention, the present invention the following technical schemes are provided:
The present invention provides a kind of dry chemistry reagent pieces for quantitative determining uric acid concentration, include four laminations, are followed successively by branch
Hold layer, color layer, reagent layer and diffusion layer；
Reagent in the reagent layer includes buffer system, hydrophilic colloid, uricase, peroxidase, chelating agent, swashs
Agent living；Dosage of each component are as follows:
Reagent in the color layer includes chromogen, hydrophilic colloid and surfactant.
Testing principle are as follows: liquid sample is added dropwise in analoids diffusion layer, reagent layer is uniformly distributed and is transported to, in reagent layer
Hydrogen peroxide is decomposited into oxygen by being oxidized generation allantoin and hydrogen peroxide, subsequent peroxidase under the action of uricase
Free radical, make the 4-AA and N- ethyl-N- (2- hydroxyl -3- sulfopropyl) -3,5- dimethoxy in color layer
Aniline sodium is oxidized to blue quinonoid compound, and under 590nm wavelength, the variation through reflective spectrophotometry measurement reflectivity is led to
Cross the concentration that standard curve calculates uric acid.By reaction temperature control under the conditions of 37 DEG C ± 1 DEG C, measurement in 5 minutes can be complete
At.Sample is added dropwise in diffusion layer, is measured in opposite one side, colored intensity is high, reduces bubble, excess that the measurement of sample-adding end generates
Liquid, turbidity and caused by interfere.Simultaneously because color layer is hydrophilic colloid, there is very high colour developing evenness.
The dry chemistry reagent piece of above structure is mainly used for measuring serum, urine, whole blood equal samples, mixes the sample with before measurement
Suitable isotonic solution is diluted, then is measured.
Preferably, buffer system is Tris buffer, glycine buffer, MOPS or phosphate-buffered in reagent layer
Liquid, pH value is 7.5~8.0；Chelating agent is EDTA；Activator is potassium ferrocyanide.
Preferably, the pH value of buffer system is 7.5~7.7.
Preferably, dosage of each component in reagent layer are as follows:
Preferably, hydrophilic colloid is selected from polyvinyl alcohol, amylopectin, cellulose esters, agarose, polyvinylpyrrolidine
One of ketone, polyacrylamide, hydroxypropyl methyl cellulose, Copolymer of Methyl Vinyl Ether/Maleic Anhydride are a variety of.
Preferably, hydrophilic colloid is the mixture of hydroxypropyl methyl cellulose and polyvinyl alcohol.
In a specific embodiment provided by the invention, dosage of each component in reagent layer are as follows:
In another specific embodiment provided by the invention, dosage of each component in reagent layer are as follows:
Preferably, chromogen is made of A and B in color layer, the A is 4-AA, and B is selected from phenol, to chlorine
Phenol, P-hydroxybenzoic acid, N- ethyl-N- (2- hydroxyl -3- sulfopropyl) -3,5- dimethoxyaniline sodium, N- ethyl-N- (2- hydroxyl
Base -3- sulfopropyl) -3- methylaniline sodium, one of 3,5- dichloro sodium hydroxybenzenesulfonate or a variety of.
Preferably, surfactant is selected from polyoxyethylene sorbitan monooleate 80, sodium taurocholate, gathers in color layer
Ethylene oxide laurel ether, 3- [3- (gallbladder amido propyl) dimethylamino] propane sulfonic acid inner salt, polyethylene glycol are in isooctyl phenyl ether
It is one or more of.
Preferably, dosage of each component in color layer are as follows:
10~200g/m of hydrophilic colloid2；
0.1~5g/m of surfactant2；
0.5~30mmol/m of chromogen2。
Preferably, in color layer chromogen by 4-AA and N- ethyl-N- (2- hydroxyl -3- sulfopropyl) -3,5-
Dimethoxyaniline sodium composition, surfactant is polyethylene glycol to isooctyl phenyl ether in color layer, each component in color layer
Dosage are as follows:
It is highly preferred that dosage of each component in color layer are as follows:
In a specific embodiment provided by the invention, dosage of each component in color layer are as follows:
In another specific embodiment provided by the invention, dosage of each component in color layer are as follows:
Preferably, diffusion layer is made of hydrophilic high molecular polymer, surfactant, particulate matter；In diffusion layer
Dosage of each component are as follows:
10~100g/m of hydrophilic high molecular polymer2；
0.1~5g/m of surfactant2；
10~400g/m of particulate matter2。
Preferably, in diffusion layer, hydrophilic high molecular polymer be selected from polyurethane, polyamide, sodium carboxymethylcellulose,
One of polyvinyl alcohol, amylopectin, xanthan gum, sodium alginate, gum arabic, peach gum, chitosan, polyvinylacetate
Or it is a variety of；Hydrophilic high molecular polymer has porous structure, can filter out the interfering substance in sample.
Preferably, hydrophilic high molecular polymer is polyurethane.
Preferably, surfactant is polyethylene glycol to isooctyl phenyl ether.
In a specific embodiment provided by the invention, dosage of each component in diffusion layer are as follows:
In another specific embodiment provided by the invention, dosage of each component in diffusion layer are as follows:
Preferably, particulate matter is selected from pigment, crystallite colloid, silica, resin bead, bead, diatomite, fiber
One of plain ester is a variety of.
Preferably, particulate matter is silica and cellulose esters.
Preferably, support layer is the polymer of polyethylene terephthalate, with a thickness of 50~300 microns.
Preferably, support layer is with a thickness of 100~200 microns.
Preferably, the surface of support layer is by ultraviolet irradiation, corona or coating bottom layer treatment.
Preferably, support layer is handled by ultraviolet irradiation.
The present invention also provides the preparation methods of the dry chemistry reagent piece, include the following steps:
Developing solution reagent, reaction solution reagent are sequentially coated on support layer, diffusion liquid reagent is then sprayed on support
It is dry on layer, obtain successively include support layer, color layer, reagent layer and diffusion layer dry chemistry reagent piece；
Reagent in reagent layer includes buffer system, hydrophilic colloid, uricase, peroxidase, chelating agent, activation
Agent；Dosage of each component are as follows:
Reagent in the color layer includes chromogen, hydrophilic colloid and surfactant.
Preferably, the surface of support layer is by ultraviolet irradiation, corona or coating bottom layer treatment.
Preferably, the coating method of color layer and reagent layer includes prepared by the modes such as levelling, extension stream, the viscous, coating of rolling, work
To be preferred, preparation method is coating.
The present invention provides a kind of dry chemistry reagent pieces and preparation method thereof for quantitative determining uric acid concentration.The dry chemistry test
Agent piece includes four laminations, is followed successively by support layer, color layer, reagent layer and diffusion layer；Reagent in reagent layer includes buffer body
System, hydrophilic colloid, uricase, peroxidase, chelating agent, activator；Reagent in color layer includes chromogen, hydrophilic gel
Body and surfactant.Compared with prior art, the invention has the following advantages that
(1) operating process is simple, and pattern detection is directly added dropwise without preparing in reagent.
(2) the dry no moisture of reagent layer, analoids have good stability.
(3) diffusion layer has filtering function, and the endogenous such as haemolysis, bilirubin and ascorbic acid interfere sample to measurement result
Do not significantly interfere with.
(4) testing result is reproducible, accuracy is high, can carry out quantitative detection, and the range of linearity is wide.
(5) preparation process is easy, and easy to operate, harmfulness, pollution are small.
Experiment shows the dry chemistry reagent piece of quantitatively determining human blood uric acid concentration of the present invention, and testing result is quasi-
True property is high, and precision is good, and specificity is good, and stability is good, and long shelf-life is easy to operate, applied widely, without professional etc.
Advantage supplements the shortcoming of wet chemistry method well, and accuracy of measurement and precision are already close to wet chemical determination side
Method is provided a great convenience in clinical field of fast detection.
Specific embodiment
The invention discloses a kind of dry chemistry reagent piece and preparation method thereof for quantitative determining uric acid concentration, art technologies
Personnel can use for reference present disclosure, be suitably modified realization of process parameters.In particular, it should be pointed out that all similar replacements and changing
Move apparent to those skilled in the art, they are considered as being included in the present invention.It method of the invention and answers
With being described by preferred embodiment, related personnel can obviously not depart from the content of present invention, in spirit and scope
To method described herein and application is modified or appropriate changes and combinations, carrys out implementation and application the technology of the present invention.
Agents useful for same or instrument in dry chemistry reagent piece of quantitative determination uric acid concentration provided by the invention and preparation method thereof
Device is available on the market.
Below with reference to embodiment, the present invention is further explained:
Embodiment 1: the preparation method of uric acid dry chemistry reagent piece of the present invention
Transparent support layer material uses polyethylene terephthalate material, with a thickness of 0.178mm, length 20cm,
Width is 20cm.Surface is handled by ultraviolet irradiation, irradiation distance 5cm, and irradiation time 20 minutes.
The formula of developing solution reagent is as follows:
The formula of reaction solution reagent is as follows:
Color layer is coated on the polyethylene terephthalate support layer Jing Guo ultraviolet processing, and reagent layer is continuously applied
It overlays on color layer, is put into drying box, 30 DEG C dry 20 minutes.
The formula of diffusion liquid reagent is as follows:
Diffusion liquid is uniformly sprayed on reagent layer, is put into drying box and dries.13mm is cut to strip cutting machine
The test-paper of × 13mm size, is sealed with aluminium foil bag.
Detection method: 9 μ L test samples are added dropwise and are incubated for 5 minutes under analoids, 37 DEG C of constant temperatures, reflecting light is used
Degree meter is measured, and the concentration of uric acid in sample is calculated according to standard curve.
Embodiment 2: the accuracy analysis of the method for the invention
Test sample: 20 examinee's blood samples；
Contrasting detection method: complete certainly in Hitachi 7080 with commercially available uric acid detection kit (enzymatic measurement) 4:1 liquid reagent
It is detected on Automatic Biochemical Analyzer, 2.5 μ L samples is added by automatic clinical chemistry analyzer, one 200 μ L of reagent, reagent 2 50 μ L, 37
DEG C reaction 10 minutes, measure the absorbance value of 510nm, according to standard curve calculate sample in uric acid concentration.
20 samples are measured respectively with 1 detection method of embodiment and contrasting detection method, and testing result is shown in Table 1.
Table 1 analyzes result
The results show that calculated R according to testing result2Value is 0.9978, is greater than 0.95, shows the method for the invention
Testing result and contrast agent box testing result no significant difference have high accuracy (degree of conformity).
Embodiment 3: the Precision Analyze of the method for the invention
Test sample: any one blood serum sample；
Detection 10 times is repeated to same sample to be tested with 1 detection method of embodiment, testing result is shown in Table 2.
2 test sample uric acid concentration of table (10 times) and standard rate (coefficient of variation)
The results show that standard rate is 1.55%, less than the 10% of standard requirements, show that the method for the invention has height
Precision.
Embodiment 4: the linear analysis of the method for the invention
Test sample: high concentration uric acid sample (800 μm of ol/L)；
Uric acid sample is diluted to 6 different concentration, is followed successively by 0 μm of ol/L, 100 μm of ol/L, 200 μm of ol/L, 400 μ
Mol/L, 600 μm of ol/L, 800 μm of ol/L carry out 2 inspections to each concentration of above-mentioned sample using the detection method of embodiment 1
It surveys, calculates coefficient R value, testing result is shown in Table 3.
3 linear test result of table
The results show that be 0.9997 according to the calculated R value of testing result that 1 detection method of embodiment obtains, close to
1, show that the method for the invention has the good linearity in the range of 0 μm of ol/L-800 μm of ol/L.
Embodiment 5: the preparation method of uric acid dry chemistry reagent piece of the present invention
Transparent support layer material uses ethylene glycol terephthalate material, and with a thickness of 0.170mm, length 30cm is wide
Degree is 30cm.Surface pass through sided corona treatment, corona intensity 600W, the corona time 20 seconds.
The formula of developing solution reagent is as follows:
The formula of reaction solution reagent is as follows:
Color layer is coated on the polyethylene terephthalate support layer Jing Guo ultraviolet processing, and reagent layer is continuously applied
It overlays on color layer, is put into drying box, 30 DEG C dry 20 minutes.
The formula of diffusion liquid reagent is as follows:
Diffusion liquid is uniformly sprayed on reagent layer, is put into drying box and dries.11mm is cut to strip cutting machine
The test-paper of × 11mm size, is sealed with aluminium foil bag.
Detection method: 10 μ L test samples are added dropwise and are incubated for 5 minutes under analoids, 37 DEG C of constant temperatures, use is reflective
Photometer is measured, and the concentration of uric acid in sample is calculated according to standard curve.
Embodiment 6: the stability analysis of the method for the invention
Condition of storage: sealing is placed in 2-8 DEG C of refrigerator.
Round of visits: when 2-8 DEG C 0, March, September, 15 months, 18 months, 21 months.
It is detected with the detection method of embodiment 5 in above-mentioned round of visits, accuracy in computation, precision, linear model
It encloses, testing result is shown in Table 4.
4 stability test result of table
The results show that the calculated R of testing result obtained according to 5 detection method of embodiment2Value is all larger than 0.95, standard
Rate is respectively less than 10%, the R value of standard requirements all close to 1, shows that the method for the invention stores 21 under the conditions of 2-8 DEG C
Month, analoids still have good accuracy, precision, the range of linearity.
Embodiment 7: the anti-Interference Analysis of the method for the invention
Test sample: bilirubin (20mg/dL) is added in check sample serum, check sample serum in check sample serum
Middle addition ascorbic acid (3mg/dL)；
3 detections are carried out to above-mentioned sample using the detection method of embodiment 5, experiment with computing sample is relative to check sample
Bias produced by measurement result, testing result are shown in Table 5.
5 anti-interference test result of table
The results show that the calculated D of testing result obtained according to 5 detection method of embodimentobsRespectively less than Dc, do not observe
It is influenced to clinical significance, shows the method for the invention in the bilirubin of 20mg/dL concentration and the Vitamin C of 3mg/dL concentration
Acid does not significantly interfere with measurement result.
Comparative example 1: the preparation method of uric acid dry chemistry reagent piece described in other methods
Transparent support layer material uses polyethylene terephthalate material, with a thickness of 0.20mm, color layer and reaction
Layer uses nitrocellulose filter, and diffusion layer uses nylon membrane.By color layer, conversion zone and diffusion layer be separately immersed in developing solution,
In reaction solution and diffusion liquid, takes out, strike off after soaking completely.It is put into 20 DEG C of drying box, is taken out after dry, color layer is glued
It is affixed on support layer, then is successively compacted conversion zone and diffusion layer.
The formula of developing solution reagent is as follows:
Polyethylene glycol is to isooctyl phenyl ether 1.0g/L；
4-AA 1.0mmol/L；
N- ethyl-N- (2- hydroxyl -3- sulfopropyl) -3,5- dimethoxyaniline sodium 3.0mmol/L；
The formula of reaction solution reagent is as follows:
The formula of diffusion liquid reagent is as follows:
Polyethylene glycol is to isooctyl phenyl ether 1.0g/L；
It is cut to the test-paper of 13mm × 13mm size with strip cutting machine, is sealed with aluminium foil bag.
Detection method: 10 μ L test samples are added dropwise and are incubated for 5 minutes under analoids, 37 DEG C of constant temperatures, use is reflective
Photometer is measured, and the concentration of uric acid in sample is calculated according to standard curve.
The Precision Analyze of 2 comparative example of comparative example, 1 method the method
Test sample: any one blood serum sample；
Detection 10 times is repeated to same sample to be tested with 1 detection method of comparative example, testing result is shown in Table 6.
6 test sample uric acid concentration of table (10 times) and standard rate (coefficient of variation)
The results show that standard rate is 3.95%, hence it is evident that be greater than embodiment standard rate 1.55%, show of the present invention
Method has high precision.
The linear analysis of 3 comparative example of comparative example, 1 method the method
Test sample: high concentration uric acid sample (800 μm of ol/L)；
Uric acid sample is diluted to 6 different concentration, is followed successively by 0 μm of ol/L, 100 μm of ol/L, 200 μm of ol/L, 400 μ
Mol/L, 600 μm of ol/L, 800 μm of ol/L carry out 2 inspections to each concentration of above-mentioned sample using the detection method of comparative example 1
It surveys, calculates coefficient R value, testing result is shown in Table 7.
7 linear test result of table
The results show that being 0.9986 according to the calculated R value of testing result that 1 detection method of comparative example obtains, and implement
It is good to show that the method for the invention has in the range of 0 μm of ol/L-800 μm of ol/L for example R value 0.9997 closer to 1
The linearity.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered
It is considered as protection scope of the present invention.
Claims (10)
1. a kind of dry chemistry reagent piece for quantitative determining uric acid concentration, which is characterized in that include four laminations, be followed successively by support
Layer, color layer, reagent layer and diffusion layer；
Reagent in the reagent layer includes buffer system, hydrophilic colloid, uricase, peroxidase, chelating agent, activation
Agent；Dosage of each component are as follows:
Reagent in the color layer includes chromogen, hydrophilic colloid and surfactant.
2. dry chemistry reagent piece according to claim 1, which is characterized in that in the reagent layer, buffer system Tris
Buffer, glycine buffer, MOPS buffer or phosphate buffer, pH value is 7.5~8.0；Chelating agent is EDTA；Activation
Agent is potassium ferrocyanide.
3. dry chemistry reagent piece according to claim 1, which is characterized in that dosage of each component in the reagent layer are as follows:
4. dry chemistry reagent piece according to claim 1, which is characterized in that the hydrophilic colloid be selected from polyvinyl alcohol,
Amylopectin, cellulose esters, agarose, polyvinylpyrrolidone, polyacrylamide, hydroxypropyl methyl cellulose, ethylene methacrylic
One of base ether/copolymer-maleic anhydride is a variety of.
5. dry chemistry reagent piece according to claim 1, which is characterized in that chromogen is made of A and B in the color layer,
The A is 4-AA, and B is selected from phenol, parachlorphenol, P-hydroxybenzoic acid, N- ethyl-N- (2- hydroxyl -3- sulphur third
Base) -3,5- dimethoxyaniline sodium, N- ethyl-N- (2- hydroxyl -3- sulfopropyl) -3- methylaniline sodium, 3,5- dichloro hydroxy benzenes
One of sodium sulfonate is a variety of, and surfactant is polyoxyethylene sorbitan monooleate 80, sodium taurocholate, polyoxyethylene
Laurel ether, 3- [3- (gallbladder amido propyl) dimethylamino] propane sulfonic acid inner salt, polyethylene glycol to one of isooctyl phenyl ether or
It is several；Dosage of each component in the color layer are as follows:
10~200g/m of hydrophilic colloid2；
0.1~5g/m of surfactant2；
0.5~30mmol/m of chromogen2。
6. dry chemistry reagent piece according to claim 1, which is characterized in that the diffusion layer is polymerize by hydrophilic macromolecule
Object, surfactant, particulate matter；Dosage of each component in diffusion layer are as follows:
10~100g/m of hydrophilic high molecular polymer2；
0.1~5g/m of surfactant2；
10~400g/m of particulate matter2。
7. dry chemistry reagent piece according to claim 6, which is characterized in that in the diffusion layer, the hydrophily high score
Sub- polymer be selected from polyurethane, polyamide, sodium carboxymethylcellulose, polyvinyl alcohol, amylopectin, xanthan gum, sodium alginate, Ah
Draw one of uncle's natural gum, peach gum, chitosan, polyvinylacetate or a variety of；
Surfactant is polyoxyethylene sorbitan monooleate 80, sodium taurocholate, polyoxyethylene laurel ether, 3- [3- (gallbladder acyl
Amine propyl) dimethylamino] propane sulfonic acid inner salt, polyethylene glycol is to one or more of isooctyl phenyl ether；
The particulate matter is in pigment, crystallite colloid, silica, resin bead, bead, diatomite, cellulose esters
It is one or more.
8. dry chemistry reagent piece according to claim 1, which is characterized in that the support layer is poly terephthalic acid second two
The polymer of alcohol ester, with a thickness of 50~300 microns.
9. the preparation method of dry chemistry reagent piece as described in any one of claims 1 to 8, which is characterized in that including walking as follows
It is rapid:
Developing solution reagent, reaction solution reagent are sequentially coated on support layer, then diffusion liquid reagent is sprayed on support layer,
It is dry, obtain successively include support layer, color layer, reagent layer and diffusion layer dry chemistry reagent piece；
Reagent in the reagent layer includes buffer system, hydrophilic colloid, uricase, peroxidase, chelating agent, activation
Agent；Dosage of each component are as follows:
Reagent in the color layer includes chromogen, hydrophilic colloid and surfactant.
10. preparation method according to claim 9, which is characterized in that ultraviolet irradiation, electricity are passed through in the surface of the support layer
Dizzy or coating bottom layer treatment.
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| CN110687108A (en) * | 2019-10-17 | 2020-01-14 | 山东瑞思康生物科技有限公司 | Multilayer film dry chemical reagent strip for quantitatively detecting urine malondialdehyde |
| CN110777191A (en) * | 2019-10-31 | 2020-02-11 | 无锡锦帛诚医疗器械科技有限公司 | Dry tablet reagent for quantitative detection of uric acid |
| CN113125427A (en) * | 2021-04-07 | 2021-07-16 | 中国科学院苏州生物医学工程技术研究所 | Dry chemical reagent sheet for simultaneously detecting uric acid, blood sugar and triglyceride |
| CN115201186A (en) * | 2022-07-14 | 2022-10-18 | 天宇华宏(北京)医学科技股份有限公司 | Test strip for detecting uric acid in saliva and preparation method thereof |
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