CN109916890A - A kind of dry chemistry reagent piece and preparation method thereof quantitative determining total cholesterol concentration - Google Patents
A kind of dry chemistry reagent piece and preparation method thereof quantitative determining total cholesterol 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 total cholesterol 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, peroxidase, activator, surfactant, stabilizer；Reagent in color layer includes chromogen, hydrophilic colloid.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 haemolysis, bilirubin and ascorbic acid sample do 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 quantitative determination total cholesterol concentration
Dry chemistry reagent piece and preparation method thereof.
Background technique
Serum total cholesterol refers to that the summation of cholesterol contained by all lipoprotein in blood, including free cholesterol and gallbladder are consolidated
Alcohol ester.Liver is the major organs of synthesis and storage.The higher liver for illustrating human body of total cholesterol and lung take place substantive
Lesion.Crowd's total cholesterol level depends primarily on inherent cause and life style.Cholesterol be synthesis cortex hormone of aadrenaline,
The important source material of the physiological activators such as sex hormone, bile acid and vitamin D, and constitute the main component of cell membrane, blood
Clear concentration can be used as the index of lipid metaboli.The cholesterol of human body can also be synthesized by acetyl coenzyme A in vivo in addition to from food,
Adult human liver and small intestine can provide about 90% endogenous cholesterol.Serum cholesterol level is influenced by age, gender etc..Except family
Outside race's property hypercholesterolemia, serum cholesterol, which increases, to be more common in secondary to nephrotic syndrome, Hypothyroidism, diabetes
With obstruction of biliary tract etc..Since serum total cholesterol and atherosclerosis, coronary heart disease, cerebro-vascular diseases relationship are close
It cuts, serum total cholesterol determination has become the conventional project of Analysis of blood lipid.
The method of measurement total cholesterol can be divided into two methods of liquid reagent and dry chemistry reagent by types of agents at present.
The detection method of liquid reagent mainly has spectrophotometry, Optical Rotation, gas chromatography, high performance liquid chromatography
Deng.These methods carry out detection to total cholesterol concentration and need specific equipment, and equipment itself costly, does not have economy
Property；It needs professional technician to operate instrument simultaneously, does not have due universality.Method measure the period it is long, analytic process compared with
For complexity, the real time measure of total cholesterol cannot achieve.
Dry chemical belongs to solid state chemistry scope, it refers to for liquid sample being applied directly to the cured examination in special construction
In agent carrier, that is, so-called dry type reagent, using the water in sample as solvent by the reagent being solidificated on carrier dissolution after again with sample
Ingredient to be measured in product is chemically reacted, to carry out a kind of method of analysis measurement.
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 piece for quantitative determining total cholesterol concentration and its preparation sides
Method.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, is applicable in model
It encloses wide.
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 total cholesterol concentration, include four laminations, successively
For support layer, color layer, reagent layer and diffusion layer；
Reagent in reagent layer includes buffer system, hydrophilic colloid, peroxidase, activator, surfactant, steady
Determine agent；Dosage of each component are as follows:
Reagent in color layer includes chromogen, hydrophilic colloid.
Testing principle are as follows: liquid sample is added dropwise in analoids diffusion layer, is uniformly distributed and is transported to reagent layer, on diffusion layer
Surfactant make cholesterol in sample and cholesteryl ester and lipoprotein isolation.Cholesterol esterase is hydrolyzed into cholesteryl ester
Cholesterol, then under the action of cholesterol oxidase, cholesterol oxidation is at ketosteroid and hydrogen peroxide.Finally, hydrogen peroxide
Make the 4-AA and N- ethyl-N- (2- hydroxyl -3- sulphur third in color layer under the catalytic action of peroxidase
Base) -3,5- dimethoxyaniline sodium is oxidized to blue quinonoid compound, under 590nm wavelength, measured through reflective spectrophotometry
The variation of reflectivity calculates the concentration of total cholesterol by standard curve.By reaction temperature control under the conditions of 37 DEG C ± 1 DEG C,
Measurement can be completed in 5 minutes.Sample is added dropwise in diffusion layer, is measured in opposite one side, colored intensity is high, reduces sample-adding end
Measure generate bubble, excess liq, turbidity and caused by interfere.Simultaneously because color layer is hydrophilic colloid, have very high
Develop the color 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, MOPSO buffer, citrate buffer solution, sweet ammonia in reagent layer
Acid buffer, MOPS buffer or phosphate buffer, pH value is 7.0~8.0；
Preferably, the pH value of buffer system is 7.1~7.3；
Preferably, activator is magnesium sulfate；
Preferably, stabilizer is polyethylene glycol-6000；
Preferably, surfactant is polyoxyethylene sorbitan monooleate 80, sodium taurocholate, polyoxyethylene laural
Ether, 3- [3- (gallbladder amido propyl) dimethylamino] propane sulfonic acid inner salt, polyethylene glycol are to one or more of isooctyl phenyl ether.
Preferably, surfactant is polyethylene glycol to isooctyl phenyl ether.
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 polyvinylpyrrolidone.
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, each component is used in color layer
Amount are as follows:
10~100g/m of hydrophilic colloid2；
0.6~30mmol/m of chromogen2。
Preferably, in color layer chromogen by 4-AA and N- ethyl-N- (2- hydroxyl -3- sulfopropyl) -3,5-
Dimethoxyaniline sodium forms, dosage of each component in color layer are as follows:
10~100g/m of hydrophilic colloid2；
0.1~5mmol/m of 4-AA2；
N- ethyl-N- (2- hydroxyl -3- sulfopropyl) 0.5~20mmol/m of -3,5- dimethoxyaniline sodium2；
It is highly preferred that dosage of each component in color layer are as follows:
20~40g/m of hydrophilic colloid2；
0.1~0.5mmol/m of 4-AA2；
N- ethyl-N- (2- hydroxyl -3- sulfopropyl) 0.5~5mmol/m of -3,5- dimethoxyaniline sodium2。
Preferably, diffusion layer by buffer system, hydrophilic high molecular polymer, cholesterol oxidase, cholesterol esterase,
Surfactant 1, surfactant 2, particulate matter；Dosage of each component in diffusion layer are as follows:
Preferably, buffer system is Tris buffer, MOPSO buffer, citrate buffer solution, sweet ammonia in diffusion layer
Acid buffer, MOPS buffer or phosphate buffer, pH value is 7.0~8.0；
Preferably, hydrophilic high molecular polymer be selected from polyurethane, polyamide, sodium carboxymethylcellulose, polyvinyl alcohol,
One of amylopectin, xanthan gum, sodium alginate, gum arabic, peach gum, chitosan, polyvinylacetate are a variety of；Parent
Aqueous polymer has porous structure, can filter out the interfering substance in sample；
Preferably, hydrophilic high molecular polymer is polyurethane；
Preferably, surfactant 1 is polyoxyethylene sorbitan monooleate 80, sodium taurocholate, the polyoxyethylene moon
Osmanthus ether, 3- [3- (gallbladder amido propyl) dimethylamino] propane sulfonic acid inner salt, polyethylene glycol are to one of isooctyl phenyl ether or several
Kind；
Preferably, surfactant 1 is sodium taurocholate.
Preferably, surfactant 2 is polyoxyethylene sorbitan monooleate 80, sodium taurocholate, the polyoxyethylene moon
Osmanthus ether, 3- [3- (gallbladder amido propyl) dimethylamino] propane sulfonic acid inner salt, polyethylene glycol are to one of isooctyl phenyl ether or several
Kind；
Preferably, surfactant 2 is polyethylene glycol to isooctyl phenyl ether.
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, the surface of 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, peroxidase, activator, surfactant, steady
Determine agent；Dosage of each component are as follows:
Reagent in color layer includes chromogen, hydrophilic colloid.
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 total cholesterol concentration.The desiccation
Learning analoids includes four laminations, is followed successively by support layer, color layer, reagent layer and diffusion layer；Reagent in reagent layer includes slow
Rush system, hydrophilic colloid, peroxidase, activator, surfactant, stabilizer；Reagent in color layer include chromogen,
Hydrophilic colloid；Reagent in diffusion layer includes buffer system, hydrophilic high molecular polymer, cholesterol oxidase, cholesterol
Esterase, surfactant, particulate matter.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 haemolysis, bilirubin and ascorbic acid sample obviously do not do measurement result
It disturbs.
(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 total cholesterol concentration of the present invention, detection knot
Fruit accuracy is high, and precision is good, and specificity is good, and stability is good, and long shelf-life is easy to operate, applied widely, is not necessarily to professional people
The advantages that member, supplements the shortcoming of wet chemistry method well, and accuracy of measurement and precision are already close to wet chemical determination
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 total cholesterol concentration, this fields
Technical staff can use for reference present disclosure, be suitably modified realization of process parameters.In particular, it should be pointed out that all similar replacements
Apparent to those skilled in the art with changing, they are considered as being included in the present invention.Method of the invention
And application is described by preferred embodiment, related personnel can obviously not depart from the content of present invention, spirit and model
Enclose it is interior method described herein and application are modified or appropriate changes and combinations, carry out implementation and application the technology of the present invention.
Agents useful for same in dry chemistry reagent piece of quantitative determination total cholesterol concentration provided by the invention and preparation method thereof
Or instrument is available on the market.
Below with reference to embodiment, the present invention is further explained:
Embodiment 1: the preparation method of total cholesterol dry chemistry reagent piece of the present invention
Transparent support layer material uses polyethylene terephthalate material, with a thickness of 0.178mm, length 30cm,
Width is 20cm.Surface is handled by ultraviolet irradiation, irradiation distance 10cm, and irradiation time 60 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.10mm is cut to strip cutting machine
The test-paper of × 10mm size, is sealed with aluminium foil bag.
Detection method: 8 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 total cholesterol 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: with commercially available total cholesterol detection kit (GOD-PAP method) 4:1 liquid reagent in Hitachi 7080
It is detected on automatic clinical chemistry analyzer, 2.0 μ L samples, reagent one 160 μ L, 2 40 μ of reagent is added by automatic clinical chemistry analyzer
L, 37 DEG C are reacted 10 minutes, and the absorbance value of 590nm is measured, and the concentration of total cholesterol in sample is calculated according to standard curve.
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 0.9933, 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 total cholesterol concentration of table (10 times) and standard rate (coefficient of variation)
The results show that standard rate is 1.88%, 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 total cholesterol sample (9mmol/L)；
Total cholesterol sample is diluted to 6 different concentration, be followed successively by 0mmol/L, 1.25mmol/L, 2.5mmol/L,
5.0mmol/L, 7.5mmol/L, 9mmol/L carry out each concentration of above-mentioned sample 2 times using the detection method of embodiment 1
Detection, calculates coefficient R value, and testing result is shown in Table 3.
3 linear test result of table
The results show that it is bordering on 1 for 0.9992 according to the calculated R value of testing result that 1 detection method of embodiment obtains, table
Bright the method for the invention has the good linearity in the range of 0.0mmol/L-9mmol/L.
Embodiment 5: the preparation method of total cholesterol dry chemistry reagent piece of the present invention
Transparent support layer material uses ethylene glycol terephthalate material, with a thickness of 0.20mm, length 30cm, width
For 30cm.Surface pass through sided corona treatment, corona intensity 600W, the corona time 5 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, 35 DEG C dry 10 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.12mm is cut to strip cutting machine
The test-paper of × 12mm size, is sealed with aluminium foil bag.
Detection method: 8 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 total cholesterol 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 total cholesterol 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 glass fibre.Color layer, conversion zone and diffusion layer are separately immersed in colour developing
In liquid, reaction solution and diffusion liquid, takes out, strike off after soaking completely.It is put into 20-30 DEG C of drying box, takes out, will show after dry
Chromatograph is pasted 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 2.0mmol/L；
N- ethyl-N- (2- hydroxyl -3- sulfopropyl) -3,5- dimethoxyaniline sodium 6.0mmol/L；
The formula of reaction solution reagent is as follows:
The formula of diffusion liquid reagent is as follows:
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 total cholesterol 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 total cholesterol concentration of table (10 times) and standard rate (coefficient of variation)
The results show that standard rate is 3.92%, hence it is evident that be greater than embodiment standard rate 1.88%, 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 total cholesterol sample (9mmol/L)；
Total cholesterol sample is diluted to 6 different concentration, be followed successively by 0mmol/L, 1.25mmol/L, 2.5mmol/L,
5.0mmol/L, 7.5mmol/L, 9mmol/L carry out each concentration of above-mentioned sample 2 times using the detection method of comparative example 1
Detection, calculates coefficient R value, and testing result is shown in Table 7.
7 linear test result of table
The results show that being 0.9988 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 0.0mmol/L-9.0mmol/L for the R value 0.9992 closer to 1 of example 1
The good 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 total cholesterol concentration, which is characterized in that include four laminations, be followed successively by branch
Hold layer, color layer, reagent layer and diffusion layer；
Reagent in the reagent layer includes buffer system, hydrophilic colloid, peroxidase, activator, surfactant, steady
Determine agent；Dosage of each component are as follows:
Reagent in the color layer includes chromogen, hydrophilic colloid.
2. dry chemistry reagent piece according to claim 1, which is characterized in that in the reagent layer, buffer system Tris
Buffer, MOPSO buffer, citrate buffer solution, glycine buffer, MOPS buffer or phosphate buffer, pH value exist
7.0~8.0；Activator is magnesium sulfate；Stabilizer is polyethylene glycol-6000；Surfactant is polyethenoxy sorbitan
Monoleate 80, sodium taurocholate, polyoxyethylene laurel ether, 3- [3- (gallbladder amido propyl) dimethylamino] propane sulfonic acid inner salt, poly- second two
Alcohol is to one or more of isooctyl phenyl ether.
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, dosage of each component in the color layer are as follows:
10~100g/m of hydrophilic colloid2；
0.6~30mmol/m of chromogen2。
6. dry chemistry reagent piece according to claim 1, which is characterized in that the diffusion layer is by buffer system, hydrophily
High molecular polymer, cholesterol oxidase, cholesterol esterase, surfactant 1, surfactant 2, particulate matter；Diffusion layer
Middle dosage of each component are as follows:
7. dry chemistry reagent piece according to claim 6, which is characterized in that in the diffusion layer, the buffer system is
Tris buffer, MOPSO buffer, citrate buffer solution, glycine buffer, MOPS buffer or phosphate buffer, pH
Value is 7.0~8.0；
The hydrophilic high molecular polymer be selected from polyurethane, polyamide, sodium carboxymethylcellulose, polyvinyl alcohol, amylopectin,
One of xanthan gum, sodium alginate, gum arabic, peach gum, chitosan, polyvinylacetate are a variety of；
The surfactant 1 is polyoxyethylene sorbitan monooleate 80, sodium taurocholate, polyoxyethylene laurel ether, 3- [3-
(gallbladder amido propyl) dimethylamino] propane sulfonic acid inner salt, polyethylene glycol is to one or more of isooctyl phenyl ether；
The surfactant 2 is polyoxyethylene sorbitan monooleate 80, sodium taurocholate, polyoxyethylene laurel ether, 3- [3-
(gallbladder amido 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, peroxidase, activator, surfactant, steady
Determine agent；Dosage of each component are as follows:
Reagent in the color layer includes chromogen, hydrophilic colloid.
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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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110632331A (en) * | 2019-10-31 | 2019-12-31 | 无锡锦帛诚医疗器械科技有限公司 | Dry tablet reagent for quantitative detection of total cholesterol |
| CN113138220A (en) * | 2021-04-23 | 2021-07-20 | 广州万孚生物技术股份有限公司 | Electrochemical biosensor and preparation method thereof |
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| CN113138220A (en) * | 2021-04-23 | 2021-07-20 | 广州万孚生物技术股份有限公司 | Electrochemical biosensor and preparation method thereof |
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