CN106324255A - Special protein liquid compound quality control serum with high stability for biochemistry - Google Patents

Special protein liquid compound quality control serum with high stability for biochemistry Download PDF

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Publication number
CN106324255A
CN106324255A CN201610674109.2A CN201610674109A CN106324255A CN 106324255 A CN106324255 A CN 106324255A CN 201610674109 A CN201610674109 A CN 201610674109A CN 106324255 A CN106324255 A CN 106324255A
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Prior art keywords
control product
quality
biochemistry
stability
strong
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CN201610674109.2A
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Chinese (zh)
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甘宜梧
罗维晓
谭柏清
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Biobase Biodustry Shandong Co Ltd
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Biobase Biodustry Shandong Co Ltd
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Priority to CN201610674109.2A priority Critical patent/CN106324255A/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2496/00Reference solutions for assays of biological material

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Peptides Or Proteins (AREA)

Abstract

The invention relates to a special protein liquid compound quality control serum with high stability for biochemistry, and belongs to the technical field of clinical in-vitro detection. The quality control serum is a compound liquid quality control serum which is mainly prepared from protective substances such as a buffer solution, a metal chelating agent, a surfactant, a protective agent, an ionic equilibrium agent and a preservative, and the quality control serum can detect 12 substances of antistreptococcic O, C reactive protein, a complement C3, a complement C4, IgM, IgA, IgG, prealbumin, rheumatoid factors, transferrin, total protein and albumin. Serving as the quality control serum of the 12 substances, the quality control serum has the advantages of being convenient to use and high in stability.

Description

The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product
Technical field
The biochemistry special proteins liquid that the present invention relates to a kind of stability strong is combined quality-control product, belongs to clinical vitro detection Technical field.
Background technology
Biochemistry special proteins quality-control product refers to carrying out special proteins detection project in clinical biochemical detection use process In a kind of quality control material of detecting system being held and controlling;Clinic uses widely, faces at biochemistry Bed detection in special proteins detection project the most, common are streptococcus O, alpha-fetoprotein, c reactive protein, Complement C_3, The multiple biochemical projects such as Complement C4, immunoglobulin IGA, immunoglobulin IGG, immunoglobulin IGM, prealbumin;At present The Quality Control of the special proteins used mostly is man-to-man single project, or the quality-control product of the special proteins being combined for dry powder, and Seldom there is the quality-control product of the compound special proteins of liquid, and the compound calibration object of liquid is owing to comprising the thing of multiple special proteins Matter, the process that can carry out early stage directly uses, and saves cost and the operation of configuration, also greatly facilitates clinic simultaneously Operate with, but owing to different special proteins project performances is different, stable condition is also not quite similar, liquid Mix under state and be very susceptible to decay or cross reaction, it is impossible to preserve for a long time;Therefore, it is possible to invention one is stable The special proteins of liquid be combined quality-control product, there is extraordinary Clinical practicability, be also very beneficial for the popularization of clinic and send out Exhibition.
Therefore according to these problems, the compound of a kind of highly stable liquid comprising 12 kinds of special proteins materials has been invented Quality-control product.
Summary of the invention
The biochemistry special proteins liquid that the present invention relates to a kind of stability strong is combined quality-control product.
The present invention is obtained through the following steps:
It is as follows that the biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product constituent:
Quality-control product constituent:
Buffer 50mmol/L
Metal-chelator 1 1mmol/L-5mmol/L
Metal-chelator 2 0.1ml/L-0.5 ml/L
Surfactant 1 1ml/L-3ml/L
Surfactant 2 0.5ml/L-1 ml/L
Protective agent 1 30g/L-50g/L
Protective agent 2 7.5mmol/L-10mmol/L
Protective agent 3 1mmol/L-3mmol/L
Ionic equilibrium agent 1 10g/L-20g/L
Ionic equilibrium agent 2 0.5g/L-1g/L
Preservative 0.5g/L-1g/L
Streptococcus O 250KU/L-300kU/K
C reactive protein 50mg/L-55mg/L
Complement C_3 140mg/dL-148mg/dL
Complement C4 30.0mg/dL-35mg/dL
IgM 185mg/dL-190mg/dL
IgA 240mg/dL-250mg/dL
IgG 12g/L-15g/L
Prealbumin 30mg/dL-50mg/dL
Rheumatoid factor 55U/mL-60u/mL
Transferrins 260mg/dL-280mg/dL.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, and in described reagent R, buffer is 25 DEG C, pH It it is " piperazine-1,4-two ethanesulfonic acid buffer of the 50mmol/L of 7.0.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, metal ion chelation agent in described quality-control product 1 is EDTA.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, metal ion chela described in described quality-control product Mixture 2 is 1-hydroxy ethylidene-1,1-diphosphonic acid.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, and described quality-control product surfactant 1 is bent La Tong-100.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, surfactant described in described quality-control product 2 is alkyl polyglucoside.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, and in described quality-control product, protective agent 1 is Sanguis Bovis seu Bubali Pure albumen.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, and in described quality-control product, protective agent 2 is MgSO4.7H2O。
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, and in described quality-control product, protective agent 3 is two sulfur Threitol.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, and described quality-control product intermediate ion poising agent 1 is Sodium chloride.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, and described quality-control product intermediate ion poising agent 2 is Potassium chloride.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, and in described quality-control product, preservative is that methyl is different Thiazolinone.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, and described reagent is liquid.
Beneficial effects of the present invention:
1) present invention is to comprise the compound liquid special proteins Quality Control of 10 kinds of special proteins and two kinds of routine protein (ALB and TP) Product;
2) prioritizing selection of the present invention biological buffer PIPES buffer is as buffer system, can not only effectively stablize matter The pH value of control product, but also can effectively prevent the buffer impact on various special proteins;
3) in invention, the interpolation of two metal ion species chelating agen effectively prevents the heavy metal ion impact on special proteins, to not Qualitative have bigger help, and the interpolation of surfactant effectively prevents quality-control product muddiness in use, and protectant adds Add the stability of the most extraordinary raising product.
Accompanying drawing explanation
Accompanying drawing 1 is the stability trendgram of seven kinds of special proteins of CRP, C3, C4, IGM, IGA, PALB, TRF;
Accompanying drawing 2 is the stability trendgram of tri-kinds of albumen of TP, ALB, IGG;
Accompanying drawing 3 is two kinds of special proteins stability trendgrams of ASO, RF.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further described.
Embodiment 1
It is as follows that the biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product constituent:
Quality-control product constituent:
PIPES 50mmol/L
EDTA 1mmol/L
1-hydroxy ethylidene-1,1-diphosphonic acid 0.1ml/L
TritonX-100 1ml/L
Alkyl polyglucoside 0.5ml/L
Bovine serum albumin 30g/L
7 Magnesium sulfate heptahydrate 7.5mmol/L
Dithiothreitol, DTT 1mmol/L
Sodium chloride 10g/L
Potassium chloride 0.5g/L
Methylisothiazolinone 0.5g/L
Streptococcus O 250KU/L
C reactive protein 50mg/L
Complement C_3 140mg/dL
Complement C4 30.0mg/dL
IgM 185mg/dL
IgA 240mg/dL
IgG 12g/L
Prealbumin 30mg/dL
Rheumatoid factor 55U/mL
Transferrins 260mg/dL.
Embodiment 2
What the present embodiment described is that the biochemistry special proteins liquid that a kind of stability after a kind of material increases is strong is combined Quality Control Product constituent is as follows:
Quality-control product constituent:
Buffer 50mmol/L
Metal-chelator 1 5mmol/L
Metal-chelator 2 0.5 ml/L
Surfactant 1 3ml/L
Surfactant 21 ml/L
Protective agent 1 50g/L
Protective agent 2 10mmol/L
Protective agent 3 3mmol/L
Ionic equilibrium agent 1 20g/L
Ionic equilibrium agent 2 1g/L
Preservative 1g/L
Streptococcus O 300kU/K
C reactive protein 55mg/L
Complement C_3 148mg/dL
Complement C4 35mg/dL
IgM 190mg/dL
IgA 250mg/dL
IgG 15g/L
Prealbumin 50mg/dL
Rheumatoid factor 60u/mL
Transferrins 80mg/dL.
Embodiment 3
Originally execute that example describes is the verification method of the stability of the quality-control product of the compounded special albumen that the stability of the present invention is strong,
Concrete verification method and step are as follows:
Configuration is completed in embodiment 1 or embodiment 2 the quality-control product of liquid be divided into 13 parts respectively, be stored in 2-8 DEG C In environment, choose correspondence total protein, albumin, streptococcus O, c reactive protein, Complement C_3, Complement C4, IgA, IgM, IgG, (12 kinds of reagent are selected from the Shandong Boke limited public affairs of biological industry for prealbumin, rheumatoid factor, 12 kinds of biochemical reagents of transferrins The test kit that department produces), first automatic clinical chemistry analyzer device is calibrated, and after calibrating successfully, every month detects enforcement respectively The quality-control product configured in example 1 and embodiment 2, continuous detecting 13 months, observe the situation of change of the result of quality-control product, and shape Become quality-control product stability tracing figure.

Claims (8)

1. it is as follows that the biochemistry special proteins liquid that a stability is strong is combined quality-control product constituent:
Buffer 50mmol/L
Metal-chelator 1 1mmol/L-5mmol/L
Surfactant 1 1ml/L-3ml/L
Protective agent 1 30g/L-50g/L
Protective agent 3 1mmol/L-3 mmol/L
Ionic equilibrium agent 1 10g/L-20g/L
Streptococcus O 250KU/L-300kU/K
C reactive protein 50mg/L-55mg/L
Complement C_3 140mg/dL-148mg/dL
IgM 185mg/dL-190mg/dL
IgA 240mg/dL-250mg/dL
IgG 12g/L-15g/L
Prealbumin 30mg/dL-50mg/dL
Rheumatoid factor 55U/mL-60u/mL
Transferrins 260mg/dL-280mg/dL.
2. being combined quality-control product according to the biochemistry special proteins liquid that stability a kind of described in claim 1 is strong, its feature exists In quality-control product, buffer is 25 DEG C, and pH is " piperazine-Isosorbide-5-Nitrae-two ethanesulfonic acid buffer of the 50mmol/L of 7.0.
3. being combined quality-control product according to the biochemistry special proteins liquid that stability a kind of described in claim 1 is strong, its feature exists In quality-control product, metal ion chelation agent is respectively EDTA and 1-hydroxy ethylidene-1,1-diphosphonic acid, is used in conjunction with.
4. being combined quality-control product according to the biochemistry special proteins liquid that stability a kind of described in claim 1 is strong, its feature exists It is TritonX-100 and for alkyl polyglucoside in quality-control product surfactant, is used in conjunction with.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, it is characterised in that In quality-control product, protective agent is respectively bovine serum albumin, MgSO4.7H2O and dithiothreitol, DTT, is used in conjunction with.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, it is characterised in that Quality-control product intermediate ion poising agent is sodium chloride and potassium chloride, is used in conjunction with.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, it is characterised in that In quality-control product, preservative is Methylisothiazolinone.
The biochemistry special proteins liquid that a kind of stability is strong is combined quality-control product, it is characterised in that Quality-control product is liquid.
CN201610674109.2A 2016-08-17 2016-08-17 Special protein liquid compound quality control serum with high stability for biochemistry Pending CN106324255A (en)

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107505460A (en) * 2017-08-07 2017-12-22 嘉兴博泰生物科技发展有限公司 C reactive protein quality for POCT controls the preparation method of product
CN107703314A (en) * 2017-11-15 2018-02-16 迈克生物股份有限公司 A kind of corticotropin solution and its application
CN108107224A (en) * 2017-12-18 2018-06-01 郑州安图生物工程股份有限公司 A kind of ProGRP assays liquid calibration object
CN109298176A (en) * 2018-10-29 2019-02-01 深圳天深医疗器械有限公司 Myocarditis quality-control product and preparation method thereof, myocarditis detection kit and myocarditis detection device
CN109298173A (en) * 2018-09-19 2019-02-01 南京金域医学检验所有限公司 Immunofluorescence project mixes quality-control product and its preparation method and application
CN109406796A (en) * 2018-12-11 2019-03-01 迈克生物股份有限公司 Rheumatoid factor detection reagent box and its detection method
CN109613263A (en) * 2018-12-28 2019-04-12 山东博科生物产业有限公司 A kind of blood-lipoids and the compound quality-control product of special proteins
CN109781991A (en) * 2018-12-26 2019-05-21 深圳开立生物医疗科技股份有限公司 A kind of c reactive protein saves liquid, calibration object, quality-control product and detection kit
CN110780082A (en) * 2019-11-04 2020-02-11 上海昆涞实业发展有限公司 Total complement activity quality control product, reagent, preparation method and application
CN110857905A (en) * 2018-08-22 2020-03-03 湖南爱威医疗科技有限公司 Quality control material of excrement analyzer and preparation method thereof
CN113234154A (en) * 2021-04-29 2021-08-10 四川携光生物技术有限公司 Rheumatoid factor IgG, IgM and IgA composite quality control product and preparation method and application thereof

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Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107505460A (en) * 2017-08-07 2017-12-22 嘉兴博泰生物科技发展有限公司 C reactive protein quality for POCT controls the preparation method of product
CN107703314A (en) * 2017-11-15 2018-02-16 迈克生物股份有限公司 A kind of corticotropin solution and its application
CN107703314B (en) * 2017-11-15 2018-11-20 迈克生物股份有限公司 A kind of corticotropin solution and its application
CN108107224A (en) * 2017-12-18 2018-06-01 郑州安图生物工程股份有限公司 A kind of ProGRP assays liquid calibration object
CN110857905A (en) * 2018-08-22 2020-03-03 湖南爱威医疗科技有限公司 Quality control material of excrement analyzer and preparation method thereof
CN109298173A (en) * 2018-09-19 2019-02-01 南京金域医学检验所有限公司 Immunofluorescence project mixes quality-control product and its preparation method and application
CN109298176A (en) * 2018-10-29 2019-02-01 深圳天深医疗器械有限公司 Myocarditis quality-control product and preparation method thereof, myocarditis detection kit and myocarditis detection device
CN109406796A (en) * 2018-12-11 2019-03-01 迈克生物股份有限公司 Rheumatoid factor detection reagent box and its detection method
CN109781991A (en) * 2018-12-26 2019-05-21 深圳开立生物医疗科技股份有限公司 A kind of c reactive protein saves liquid, calibration object, quality-control product and detection kit
CN109781991B (en) * 2018-12-26 2022-06-24 深圳开立生物医疗科技股份有限公司 C-reactive protein preserving fluid, calibrator, quality control product and detection kit
CN109613263A (en) * 2018-12-28 2019-04-12 山东博科生物产业有限公司 A kind of blood-lipoids and the compound quality-control product of special proteins
CN110780082A (en) * 2019-11-04 2020-02-11 上海昆涞实业发展有限公司 Total complement activity quality control product, reagent, preparation method and application
CN110780082B (en) * 2019-11-04 2023-05-12 上海昆涞实业发展有限公司 Total complement activity quality control product, reagent, preparation method and application
CN113234154A (en) * 2021-04-29 2021-08-10 四川携光生物技术有限公司 Rheumatoid factor IgG, IgM and IgA composite quality control product and preparation method and application thereof

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