CN109916682A - A kind of preparation method of Applications of Cardiac Markers quality-control product - Google Patents
A kind of preparation method of Applications of Cardiac Markers quality-control product Download PDFInfo
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- CN109916682A CN109916682A CN201910187800.1A CN201910187800A CN109916682A CN 109916682 A CN109916682 A CN 109916682A CN 201910187800 A CN201910187800 A CN 201910187800A CN 109916682 A CN109916682 A CN 109916682A
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Abstract
The invention discloses a kind of preparation methods of Applications of Cardiac Markers quality-control product, using normal human serum as matrix liquid, impurity is removed with filter membrane after warm bath 1-3 hours, CK is added in obtained quality-control product matrix liquid, CK-MB, cTnI, cTnT, CRP, BNP, MYO, NT-proBNP, HCY, H-FABP, the Applications of Cardiac Markers positive material such as Dig, height is made, in, low three concentration levels quality-control product solution, suitable preservative is added, it is uniformly mixed after protein protective agent and stabilizer, carry out debugging measurement, after testing result is met the quality standard, it is sub-packed in vial, low-temperature vacuum drying is in 2 ~ 8 DEG C of preservations after freeze-drying state.Quality-control product of the present invention selects normal human serum/human normal plasma/to remove hormone human serum/go lipid human serum as matrix liquid, the stable entry Applications of Cardiac Markers quality-control product of the performance prepared according to clinical practice demand, viscosity is low, redissolution is fast, matrix effect is small, with extraordinary Clinical practicability, it is especially advantageous for clinical popularization and development.
Description
Technical field
The present invention relates to biological products technologies, more particularly, to a kind of preparation method of Applications of Cardiac Markers quality-control product.
Background technique
Applications of Cardiac Markers is current clinical laboratory conventional detection project.Since the structure of most of Applications of Cardiac Markers is unstable
It is fixed, still lack unified standard at present, causes using different detection methods or using the resulting inspection of testing product of different manufacturers
It surveys result and is likely to occur inconsistent adverse consequences.Quality-control product is free of in the detection kit of majority producer production at present, and
Quality-control product is prepared by clinical labororatory oneself to be influenced by factors again, so in clinical laboratory Myocardial marker detection
Quality control situation allow of no optimist, it would be highly desirable to improve.Individual Applications of Cardiac Markers (such as: BNP, NT-proBNP, cTnI) because anti-
The particularity of original structure is easy to be interfered by enzymes various in serum in clinical serum, and stability is bad, so that properties of product
It is not able to satisfy clinical requirement；Some Applications of Cardiac Markers quality-control products are using non-human serum matrix on the market, with clinical sample base
There are notable differences for matter, be easy to cause quality-control product and clinical sample detection trend inconsistent, cause matrix effect.So clinically
It is badly in need of indoor quality of the multinomial compound quality-control product of third party's Applications of Cardiac Markers of commercialization human serum matrix for laboratory to control
And External quality evaluation.
Summary of the invention
The purpose of the present invention is to provide a kind of preparation method of entry Applications of Cardiac Markers quality-control product that performance is stable, with
Meet clinical use.
To achieve the above object, the present invention can take following technical proposals:
The preparation method of Applications of Cardiac Markers quality-control product of the present invention, includes the following steps:
Serum is redissolved after restoring room temperature water-bath 1- at a temperature of 40-60 DEG C using normal human serum as matrix liquid by the first step
3 hours；
The filter membrane in 0.22 μm -0.65 μm of aperture of the serum after first step water-bath is removed impurity, obtains quality-control product base by second step
Matter liquid；
Third step adds following Applications of Cardiac Markers positive material: creatine kinase (CK) 10- in the matrix liquid made from second step
700U/L, creatine kinase isozyme 5-200ng/ml, Troponin I (cTnI) 0-20ng/ml, troponin T (cTnT) 0-
4 μ g/L, C reactive protein (CRP) 0-50mg/L, b-type natriuretic peptide (BNP) 50-3000pg/ml, myoglobins (MYO) 10-
300ng/ml, N-terminal-b-type natriuretic peptide precursor (NT-proBNP) 50-3000pg/ml, homocysteine (HCY) 0-30 μm of ol/
L, cardic fatty acid binding protein (H-FABP) 0-30ng/ml, digoxin (Dig) 0-4ng/ml, be made high, medium and low three it is dense
Spend horizontal quality-control product solution；
Suitable preservative is added in 4th step in the high, medium and low three concentration quality-control product solution that third step is prepared, albumen is protected
It is uniformly mixed after protecting agent and stabilizer；
5th step carries out debugging measurement to high, medium and low three concentration level quality-control products that the 4th step obtains, and testing result meets
It after quality standard, is sub-packed in vial, low-temperature vacuum drying is in 2 ~ 8 DEG C of preservations after freeze-drying state.
The normal human serum matrix liquid that the first step uses can be replaced human normal plasma/go hormone human serum/degreasing
Class human serum matrix liquid, HBsAg, HCV-Ab, HIV-Ab, TP results of serological detection therein are feminine gender.
In 4th step, preservative used is Proclin300, gentamicin sulphate, NaN3, Bronidox, 1,2-
One of benzisothiazole-3-ketone, methylisothiazolinone are a variety of.
Protein protective agent used in 4th step is aminopyrine, polyethylene glycol, gelatin or K30, L-lysine salt
Hydrochlorate it is one or more.
Stabilizer used in 4th step is one of trehalose, sucrose, lactose and glucan or a variety of.
Advantages of the present invention may be embodied in the following:
Quality-control product of the present invention selects normal human serum/human normal plasma/to remove hormone human serum/go lipid human serum as matrix
Liquid, the stable entry Applications of Cardiac Markers quality-control product of the performance prepared according to clinical practice demand, viscosity is low, redissolution is fast, base
Mass effect is small, has extraordinary Clinical practicability, is especially advantageous for clinical popularization and development.Meanwhile preparation method of the present invention
Simply, it is consistent as matrix liquid with clinical sample matrix especially with normal human serum, can utmostly reduce matrix
Effect, and uniformity, have good stability, not by transport, the factors such as temperature are influenced, freeze-drying sealing is placed under the conditions of 2 ~ 8 DEG C
Validity period is saved up to 24 months, effect phase stability is longer, redissolves that rear stability is good, and Quality Control detection project is complete, production cost
It is low.
The Internal Quality Control that quality-control product of the present invention can be used for each clinical labororatory's Applications of Cardiac Markers uses, and simultaneously can be used for room
Between quality evaluation organizer carry out Applications of Cardiac Markers External quality evaluation.
Specific embodiment
More detailed explanation is done to the present invention below by specific embodiment, in order to the reason of those skilled in the art
Solution.
Embodiment 1 prepares high, medium and low three horizontal Applications of Cardiac Markers quality-control products
The first step takes sera stock 1000ml, normal human serum of the sera stock from commercialization or removes hormone serum or goes
Lipid human serum, and through detecting, following index is negative: HBsAg, HCV-Ab, HIV-Ab, TP；
Serum is redissolved after restoring room temperature water-bath 1-3 hours at a temperature of 40-60 DEG C；After restoring room temperature, serum background detection knot
Fruit should meet claimed below: CK < 200U/L, CK-MB mass < ng/ml of 0.6ng/ml, CK-MB activity < 25U/L, MYO < 45,
cTnI<0.3ng/ml、cTnT<0.2ug/L、BNP<100pg/ml、NT-proBNP<300pg/ml、CRP<0.5mg/L、H-FABP
<5ng/ml, HCY<15μmol/L,Dig<0.2ng/ml；
The filter membrane in 0.22 μm -0.65 μm of aperture of the serum after first step water-bath is removed impurity, quality-control product base is made by second step
Matter liquid；
Third step is tried in above-mentioned matrix liquid according to the content addition Applications of Cardiac Markers positive high level of following Applications of Cardiac Markers
It tests: 120 U/L of creatine kinase (CK), 400 U/L, 700U/L；2 ng/ml of creatine kinase isozyme (CK-MB), 40 ng/
ml,-200ng/ml；1 ng/ml of Troponin I (cTnI), 4 ng/ml, 10ng/ml；0 μ g/L of troponin T (cTnT)
,2μg/L ,5μg/L；3 mg/L of C reactive protein (CRP), 10 mg/L, 20mg/L；100 pg/ml of b-type natriuretic peptide (BNP)
,1000 pg/ml ,2200pg/ml；50 ng/ml of myoglobins (MYO), 200 ng/ml, 400ng/ml；N-terminal-Type B natriuresis
Peptide precursor (NT-proBNP) 350,1100 pg/ml, 2500pg/ml；0 μm of ol/L of homocysteine (HCY), 5 μm of ol/L
,15μmol/L；Cardic fatty acid binding protein (H-FABP) 3ng/ml, 5ng/ml, 12ng/ml；Dig 1 ng/ml ,2ng/
ml ,5ng/ml；Content range therein refers to amount contained in quality-control product total volume, is configured to high, medium and low three levels
The Applications of Cardiac Markers quality-control product solution of concentration；
4th step is separately added into 0.1-0.5% ammonia in the high, medium and low concentration Applications of Cardiac Markers quality-control product solution that third step is prepared
Ji Bilin, 0.1-0.5%Proclin300,0.1-0.5% gentamicin sulphate, 1-5% trehalose, are debugged after mixing
Measurement；
5th step, the high, medium and low concentration Applications of Cardiac Markers quality-control product solution for meeting the quality standard requirement to testing result are sub-packed in
In vial, every bottle of dispensed loading amount is 2ml or 3ml, then open to add rubber plug, bottle after the freeze-drying of full-automatic vacuum freeze drying machine
Lid, and in Full-automatic chemiluminescence analyzer, fully automatic electric chemical illumination immunity analysis instrument, Access2 immunoassay system, life
Change and detected on analyzer, determines projects target value and term of reference, saved under the conditions of 2 ~ 8 DEG C.
The performance measurement of the quality-control product of 2 embodiment 1 of embodiment preparation
1, detected value
Each level of quality-control product is detected with corresponding reagent box in the detection system claimed, as a result see the table below 1.
Table 1
Table 1 statistics indicate that, the above results are in given range.Prove that each detection system testing result consistency is preferable.
2, uniformity
Each 10 bottles of horizontal quality-control product of same lot number is taken, every bottle of quality-control product uses corresponding reagent box to test respectively 1 time, calculates 10 tests
As a result average value () and standard deviation S1；
Separately with 1 bottle of follow-on test 10 times in above-mentioned 10 bottles of quality-control products, calculate 10 test results average value () and mark
Quasi- difference S2；The coefficient of variation CV, CV (%) should be less than 10% between bottle is calculated according to the following formula.
Formula 1,
Formula 2,
Formula 3,
Formula 4,
Work as S1<S2When, enable CVBetween bottle=0
In formula:
----average value；
S---- standard deviation；
N---- pendulous frequency；
Xi---- specifies i-th measured value of parameter.
Test result see the table below 2.
Table 2
It can be seen that the high, medium and low three horizontal quality-control products of cardiac muscle prepared by the present invention from 2 test result of table and fully meet and want
It asks.
3, stability
It saves 7 days, 37 DEG C of state of freeze-drying and accelerates 14 days for 2-8 DEG C after high, medium and low three horizontal quality-control products are successively redissolved, and it is new
The quality-control product of corkage is compared, and the range of decrease is calculated.Its test data see the table below 3:
Table 3
Conclusion: quality-control product saves 7 days, 37 DEG C in 2-8 DEG C of redissolution accelerates 14 days, compared with the quality-control product newly opened, each project
The range of decrease meets the requirements within 15%.
Claims (5)
1. a kind of preparation method of Applications of Cardiac Markers quality-control product, it is characterised in that: include the following steps:
Serum is redissolved after restoring room temperature water-bath 1- at a temperature of 40-60 DEG C using normal human serum as matrix liquid by the first step
3 hours；
The filter membrane in 0.22 μm -0.65 μm of aperture of the serum after first step water-bath is removed impurity, obtains quality-control product base by second step
Matter liquid；
Third step adds following Applications of Cardiac Markers positive material: creatine kinase 10-700U/ in the matrix liquid made from second step
L, creatine kinase isozyme 5-200ng/ml, Troponin I 0-20ng/ml, troponin T 0-4 μ g/L, C reactive protein
0-50mg/L, b-type natriuretic peptide 50-3000pg/ml, myoglobins 10-300ng/ml, N-terminal-b-type natriuretic peptide precursor 50-
3000pg/ml, 0-30 μm of ol/L of homocysteine, cardic fatty acid binding protein 0-30ng/ml, digoxin 0-4ng/
High, medium and low three concentration levels quality-control product solution is made at least one of ml；
Suitable preservative is added in 4th step in the high, medium and low three concentration quality-control product solution that third step is prepared, albumen is protected
It is uniformly mixed after protecting agent and stabilizer；
5th step carries out debugging measurement to high, medium and low three concentration level quality-control products that the 4th step obtains, and testing result meets
It after quality standard, is sub-packed in vial, low-temperature vacuum drying is in 2 ~ 8 DEG C of preservations after freeze-drying state.
2. the preparation method of Applications of Cardiac Markers quality-control product according to claim 1, it is characterised in that: the first step uses
Normal human serum matrix liquid can be replaced human normal plasma's/removing hormone human serum/and go lipid human serum matrix liquid, it is therein
HBsAg, HCV-Ab, HIV-Ab, TP results of serological detection are feminine gender.
3. the preparation method of Applications of Cardiac Markers quality-control product according to claim 1, it is characterised in that: institute in the 4th step
Preservative is Proclin300, gentamicin sulphate, NaN3, Bronidox, 1,2-benzisothiazolin-3-one, methyl
One of isothiazolinone is a variety of.
4. the preparation method of Applications of Cardiac Markers quality-control product according to claim 1, it is characterised in that: institute in the 4th step
Protein protective agent be aminopyrine, polyethylene glycol, gelatin or K30, L lysine HCL it is one or more.
5. the preparation method of Applications of Cardiac Markers quality-control product according to claim 1, it is characterised in that: institute in the 4th step
Stabilizer is one of trehalose, sucrose, lactose and glucan or a variety of.
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| CN114324891A (en) * | 2021-12-20 | 2022-04-12 | 南京诺唯赞医疗科技有限公司 | cTnI/MYO/CK-MB composite quality control product and preparation method thereof |
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Application publication date: 20190621 |