CN109239065A - A kind of stable urine total protein quality-control product and its preparation method and application - Google Patents
A kind of stable urine total protein quality-control product and its preparation method and application Download PDFInfo
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- CN109239065A CN109239065A CN201811037359.0A CN201811037359A CN109239065A CN 109239065 A CN109239065 A CN 109239065A CN 201811037359 A CN201811037359 A CN 201811037359A CN 109239065 A CN109239065 A CN 109239065A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
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Abstract
A kind of stable urine total protein quality-control product and its preparation method and application, belong to the outer diagnostic field of medical instrument biochemical precursor, solve the problems, such as in urine existing for existing urine total protein quality-control product total protein content is low and easy generation decays, can not long-term preservation, stability it is poor.Urine total protein quality-control product of the invention is made of the following components: 1~20mmol/L of buffer;5~15g/L of salt;First protective agent 0.1~1 ‰;Second protective agent 0.1~5%;0.1~2mL/L of surfactant;Purified water 1L;106~226mg/L of albumin (low value);34~74mg/L of globulin (low value);Or 317~468mg/L of albumin (high level);103~153mg/L of globulin (high level);PH is 7.2~7.4.The present invention reaches 24 months the effect phase, and stability is high, noiseless to total protein.
Description
Technical field
The invention belongs to medical instrument biochemistry vitro diagnostic techniques fields, and in particular to a kind of stable urine total protein Quality Control
Product and its preparation method and application.
Background technique
Urine total protein assay kit (kit based on total protein content in turbidimetry principle detection urine) is main
Content for total protein in Quantitative in vitro detection human urine sample.Albuminuria is that the common important clinical of nephrotic shows it
One, protein quantification has certain significance for the diagnosis, treatment and prognosis of renal lesions in urine.When kidney goes out
When existing glomerulus, renal tubular disease, Urine proteins are presented exception and increase state.Quantity of proteinuria is that nephrotic is indispensable for 24 hours
Necessary one of check.
When biochemistry refers to the total protein detection project in carrying out urine with urine total protein quality-control product, make in clinical biochemical detection
With a kind of quality control substance matter held and controlled to detection system in the process, the application in clinic is very extensive.
Urine total protein quality-control product used at present is mostly liquid dosage form, can directly use without carrying out the processing of early period, save and match
The cost and process of system, while operating with for clinic is also greatly facilitated, but total protein content is low in urine and is easy to happen
Decaying, can not long-term preservation.Therefore, a kind of long-acting stable liquid urine total protein quality-control product can be invented, is had extraordinary
Clinical practicability is also especially advantageous for clinical popularization and development.
Summary of the invention
In order to solve, total protein content in urine existing for existing urine total protein quality-control product is low and easy generation decaying, Wu Fachang
Phase saves, the problem of stability difference, and the present invention provides a kind of stable urine total protein quality-control product and its preparation method and application.
Used technical solution is as follows in order to solve the technical problem by the present invention:
A kind of stable urine total protein quality-control product of the invention, is made of the following components:
1~20mmol/L of buffer;
5~15g/L of salt;
First protective agent 0.1~1 ‰;
Second protective agent 0.1~5%;
0.1~2mL/L of surfactant;
Purified water 1L;
106~226mg/L of albumin;
34~74mg/L of globulin;
The PH of the quality-control product is 7.2~7.4;
Or, being made of the following components:
1~20mmol/L of buffer;
5~15g/L of salt;
First protective agent 0.1~1 ‰;
Second protective agent 0.1~5%;
0.1~2mL/L of surfactant;
Purified water 1L;
317~468mg/L of albumin;
103~153mg/L of globulin;
The PH of the quality-control product is 7.2~7.4.
As preferred embodiment, the buffer be selected from HEPES buffer solution, PIPES buffer, MOPS buffer,
One of disodium hydrogen phosphate-citrate buffer solution, phosphate buffer, barbital sodium-hydrochloride buffer are a variety of.
As preferred embodiment, the salt is selected from NaCL, KCL, MgCl2One of or it is a variety of.
As preferred embodiment, first protective agent is selected from sodium azide, proclin 300, P-hydroxybenzoic acid
One of ethyl ester, trehalose, sucrose, polyvinylpyrrolidone, mannose, ethylene glycol.
As preferred embodiment, second protective agent is selected from sodium azide, proclin 300, P-hydroxybenzoic acid
One of ethyl ester, trehalose, sucrose, polyvinylpyrrolidone, mannose, ethylene glycol.
As preferred embodiment, the surfactant be selected from polyoxyethylene laurel ether, triton x-100,
One of BRIJ35, EMULGEN 24B, Tween-20, Tween-80, sorbester p18 are a variety of.
A kind of preparation method of stable urine total protein quality-control product of the invention, comprising the following steps:
Purified water is added into container, buffer, salt, the first protective agent, second are then sequentially added into purified water
Protective agent, surfactant, stirring is to being completely dissolved;It is primary with 0.22um membrane filtration;In the case where temperature is 20 ± 0.5 DEG C, use
Dilute hydrochloric acid solution or 0.1% sodium hydroxide solution adjust pH value to 7.2~7.4;Albumin and ball are added into acquired solution
Albumen obtains urine total protein quality-control product.
A kind of stable urine total protein quality-control product of the invention is mainly used for evaluating a kind of based on turbidimetry principle detection urine
The accuracy of the kit of total protein content in liquid.
The beneficial effects of the present invention are:
1) present invention has selected buffer, and wide adaptability is capable of the pH value of effectively stable quality-control product, and can be avoided pair
Albumen generates reaction, noiseless to total protein.
2) additional amount of strict control salt of the present invention, can effectively improve the thermal stability of albumen, avoid environment temperature
Quality-control product is had an impact.
3) addition of surfactant improves the permeability of quality-control product, can effectively avoid quality-control product from generating muddy.
4) two kinds of protective agent combinations have spectrum antibacterial activity, and applicable PH range is wide, can be avoided microorganism to quality-control product
Caused by destroy, thus avoid albumen decaying, even failure and so on, the addition of salt improves ionic strength and heat
Stability, and combine with protective agent the stability to improve product.
5) existing urine total albumin quality-control product effect phase is generally 12 months at present, and urine total protein quality-control product of the invention
The effect phase can reach 24 months.
Detailed description of the invention
Fig. 1 is that 25 months high low value urinates total protein quality-control product measured value stability tracing figure.
Fig. 2 is that 25 months high low value urinates total protein quality-control product attenuation change figure.
Fig. 3 is that high low value urinates total protein quality-control product high temperature acceleration 7 days, 11 days, 15 days effect phase speeding-up simulation attenuation changes.
Fig. 4 is to freeze effect phase analog attenuation variation in 6,8 days under the conditions of high low value urinates -20 DEG C of total protein quality-control product.
Fig. 5 is that high low value urinates 31 days Kaifeng test results of total protein quality-control product.
Specific embodiment
A kind of stable urine total protein quality-control product of the invention is divided into low value urine total protein quality-control product and high level urine total protein
Two kinds of quality-control product.
Low value urine total protein quality-control product is made of the following components:
1~20mmol/L of buffer;
5~15g/L of salt;
First protective agent 0.1~1 ‰;
Second protective agent 0.1~5%;
0.1~2mL/L of surfactant;
Purified water 1L;
106~226mg/L of albumin;
34~74mg/L of globulin;
The PH of the quality-control product is 7.2~7.4.
High level urine total protein quality-control product is made of the following components:
1~20mmol/L of buffer;
5~15g/L of salt;
First protective agent 0.1~1 ‰;
Second protective agent 0.1~5%;
0.1~2mL/L of surfactant;
Purified water 1L;
317~468mg/L of albumin;
103~153mg/L of globulin;
The PH of the quality-control product is 7.2~7.4.
Used buffer is selected from HEPES buffer solution, PIPES buffer, MOPS buffer, disodium hydrogen phosphate-lemon
One of acid buffer, phosphate buffer, barbital sodium-hydrochloride buffer are a variety of.
Used salt is selected from NaCL, KCL, MgCl2One of or it is a variety of.
Used first protective agent is selected from sodium azide, proclin 300, ethyl-para-hydroxybenzoate, trehalose, sugarcane
One of sugar, polyvinylpyrrolidone, mannose, ethylene glycol.
Used second protective agent is selected from sodium azide, proclin 300, ethyl-para-hydroxybenzoate, trehalose, sugarcane
One of sugar, polyvinylpyrrolidone, mannose, ethylene glycol.
Used surfactant be selected from polyoxyethylene laurel ether, triton x-100, BRIJ35, EMULGEN 24B,
One of Tween-20, Tween-80, sorbester p18 are a variety of.
A kind of preparation method of stable urine total protein quality-control product of the invention, comprising the following steps:
Purified water is added into container, buffer, salt, the first protective agent, second are then sequentially added into purified water
Protective agent, surfactant, stirring is to being completely dissolved;It is primary with 0.22um membrane filtration;The condition for being 20 ± 0.5 DEG C in temperature
Under, pH value is adjusted to 7.2~7.4 with the sodium hydroxide solution of dilute hydrochloric acid solution or 0.1%;Albumin is added into acquired solution
And globulin, obtain urine total protein quality-control product.
A kind of stable urine total protein quality-control product of the invention is mainly used for evaluating a kind of based on turbidimetry principle detection urine
The accuracy of the kit of total protein content in liquid.
Invention is further described in detail with reference to embodiments.
Laboratory apparatus: high-density polyethylene drum or bottle, 100,000 grades of electronic balances, PH meter and mating calibration buffer,
1000mL graduated cylinder, dedicated filter.
The preparation of 1 low value of embodiment urine total protein quality-control product
The component and content that low value urine total protein quality-control product in the present embodiment is included are as shown in the table.
Process for preparation is as follows:
To clean with the purified water that full batch is added in container, full batch is then sequentially added in order thereto
Phosphate buffer, sodium chloride, Proclin 300, mannose, Tween-20, stirring is to being completely dissolved;With 0.22um filter membrane mistake
Filter is primary;Under conditions of temperature is 20 ± 0.5 DEG C, with the NaOH solution of dilute HCl solution or 0.1% adjust pH value to 7.2~
7.4, albumin and globulin are added into acquired solution by concentration calculation, makes the concentration low value for urinating total protein quality-control product:
205mg/L obtains low value urine total protein quality-control product;It is dispensed according to 1ml/ bottles of specification.
The preparation of 2 high level of embodiment urine total protein quality-control product
The component and content that high level urine total protein quality-control product in the present embodiment is included are as shown in the table.
Process for preparation is as follows:
To clean with the purified water that full batch is added in container, full batch is then sequentially added in order thereto
Phosphate buffer, sodium chloride, Proclin 300, mannose, Tween-20, stirring is to being completely dissolved;With 0.22um filter membrane mistake
Filter is primary;Under conditions of temperature is 20 ± 0.5 DEG C, with the NaOH solution of dilute HCl solution or 0.1% adjust pH value to 7.2~
7.4, albumin and globulin are added into acquired solution by concentration calculation, makes the concentration high level for urinating total protein quality-control product:
550mg/L obtains high level urine total protein quality-control product;It is dispensed according to 1ml/ bottles of specification.
The performance evaluation of the urine total protein quality-control product of embodiment 3
Low value urinates total protein quality-control product and high level urine total protein quality-control product is carried out according to following tests respectively.
Prepared urine total protein quality-control product is divided into 24 parts respectively, is stored in 2~8 DEG C of environment, urine is chosen
(kit based on total protein content in turbidimetry principle detection urine, producer is the auspicious medical treatment of enlightening to liquid total protein assay kit
Science and Technology Co., Ltd.), CS-1200 automatic clinical chemistry analyzer device is calibrated with Roche urine albumen calibration object first,
After calibrating successfully, to prepared urine total protein quality-control product examinations, continuous detection 25 months, total egg is urinated in observation within every 3 months
The situation of change of the result of white quality-control product, and urine total protein quality-control product stability aircraft pursuit course is formed, as shown in Figure 1;And respectively
It is tested under zero-time channel, calculates decaying, and form attenuation change curve, as shown in Figure 2;High temperature accelerates 7 days, 11 days, 15
Its effect phase speeding-up simulation, as a result as shown in Figure 3;The simulation of 6,8 days effect phases is freezed under the conditions of -20 DEG C, as a result as shown in Figure 4;31 days
Kaifeng test, as a result as shown in Figure 5.
It does not change in conclusion quality-control product of the invention can at least stablize 24 months performances in 2~8 DEG C of storages, 37
DEG C can at least stablize 15 days performances does not change, and -20 DEG C can at least stablize 6 days performances and not change, 2~8 DEG C of tear strips
30 days performances can at least be stablized under part not change, urine total protein quality-control product of the invention can be applied to full-automatic biochemical analysis
Instrument.
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 (8)
1. a kind of stable urine total protein quality-control product, which is characterized in that be made of the following components:
1~20mmol/L of buffer;
5~15g/L of salt;
First protective agent 0.1~1 ‰;
Second protective agent 0.1~5%;
0.1~2mL/L of surfactant;
Purified water 1L;
106~226mg/L of albumin;
34~74mg/L of globulin;
The PH of the quality-control product is 7.2~7.4;
Or, being made of the following components:
1~20mmol/L of buffer;
5~15g/L of salt;
First protective agent 0.1~1 ‰;
Second protective agent 0.1~5%;
0.1~2mL/L of surfactant;
Purified water 1L;
317~468mg/L of albumin;
103~153mg/L of globulin;
The PH of the quality-control product is 7.2~7.4.
2. a kind of stable urine total protein quality-control product according to claim 1, which is characterized in that the buffer is selected from
HEPES buffer solution, PIPES buffer, MOPS buffer, disodium hydrogen phosphate-citrate buffer solution, phosphate buffer, bar ratio
One of appropriate sodium-hydrochloride buffer is a variety of.
3. a kind of stable urine total protein quality-control product according to claim 1, which is characterized in that the salt is selected from
NaCL、KCL、MgCl2One of or it is a variety of.
4. a kind of stable urine total protein quality-control product according to claim 1, which is characterized in that the first protective agent choosing
From sodium azide, proclin 300, ethyl-para-hydroxybenzoate, trehalose, sucrose, polyvinylpyrrolidone, mannose, second two
One of alcohol.
5. a kind of stable urine total protein quality-control product according to claim 1, which is characterized in that the second protective agent choosing
From sodium azide, proclin 300, ethyl-para-hydroxybenzoate, trehalose, sucrose, polyvinylpyrrolidone, mannose, second two
One of alcohol.
6. a kind of stable urine total protein quality-control product according to claim 1, which is characterized in that the surfactant choosing
Selfpolyoxyethylene laurel ether, triton x-100, BRIJ35, EMULGEN 24B, Tween-20, Tween-80, one in sorbester p18
Kind is a variety of.
7. preparing a kind of method of stable urine total protein quality-control product, feature described in any one of claim 1 to 6 to exist
In, comprising the following steps:
Purified water is added into container, buffer, salt, the first protective agent, the second protection are then sequentially added into purified water
Agent, surfactant, stirring is to being completely dissolved;It is primary with 0.22um membrane filtration;In the case where temperature is 20 ± 0.5 DEG C, with dilute salt
Acid solution or 0.1% sodium hydroxide solution adjust pH value to 7.2~7.4;Albumin and globulin are added into acquired solution,
Obtain urine total protein quality-control product.
8. a kind of purposes of stable urine total protein quality-control product as described in any one of claim 1 to 6, feature exist
In for evaluating a kind of accuracy based on the kit of total protein content in turbidimetry principle detection urine.
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Cited By (8)
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CN109900887A (en) * | 2019-04-03 | 2019-06-18 | 深圳市安帝宝科技有限公司 | A kind of pretreatment liquid of urine specimen |
CN110333356A (en) * | 2019-05-30 | 2019-10-15 | 桂林优利特医疗电子有限公司 | A kind of compound Quality Control object of urine special proteins and preparation method |
CN110331186A (en) * | 2019-07-18 | 2019-10-15 | 迪瑞医疗科技股份有限公司 | A kind of 5'-NT quality-control product |
CN112067398A (en) * | 2020-09-18 | 2020-12-11 | 郑州安图生物工程股份有限公司 | Urine chemical analysis quality control product |
CN112067399A (en) * | 2020-09-18 | 2020-12-11 | 郑州安图生物工程股份有限公司 | Preparation method of urine chemical analysis quality control product |
CN112858690A (en) * | 2021-01-21 | 2021-05-28 | 宁波职业技术学院 | Urine albumin/urine creatinine composite quality control product and preparation method thereof |
CN113249367A (en) * | 2021-06-03 | 2021-08-13 | 上海蓝园生物工程有限公司 | Liquid pyranose oxidase preservation preparation and application thereof |
CN114354304A (en) * | 2021-12-07 | 2022-04-15 | 安徽惠邦生物工程有限公司 | Easily degradable protein preservation matrix liquid and application thereof |
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CN109900887A (en) * | 2019-04-03 | 2019-06-18 | 深圳市安帝宝科技有限公司 | A kind of pretreatment liquid of urine specimen |
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CN110331186A (en) * | 2019-07-18 | 2019-10-15 | 迪瑞医疗科技股份有限公司 | A kind of 5'-NT quality-control product |
CN112067398B (en) * | 2020-09-18 | 2023-11-03 | 郑州安图生物工程股份有限公司 | Urine chemical analysis quality control product |
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CN112858690A (en) * | 2021-01-21 | 2021-05-28 | 宁波职业技术学院 | Urine albumin/urine creatinine composite quality control product and preparation method thereof |
CN112858690B (en) * | 2021-01-21 | 2023-11-10 | 宁波职业技术学院 | Urine albumin/urine creatinine composite quality control product and preparation method thereof |
CN113249367A (en) * | 2021-06-03 | 2021-08-13 | 上海蓝园生物工程有限公司 | Liquid pyranose oxidase preservation preparation and application thereof |
CN113249367B (en) * | 2021-06-03 | 2024-04-02 | 上海蓝园生物工程有限公司 | Liquid pyranose oxidase preservation preparation and application thereof |
CN114354304A (en) * | 2021-12-07 | 2022-04-15 | 安徽惠邦生物工程有限公司 | Easily degradable protein preservation matrix liquid and application thereof |
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