CN109239057A - A kind of stable digoxin quality-control product and preparation method - Google Patents
A kind of stable digoxin quality-control product and preparation method Download PDFInfo
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- CN109239057A CN109239057A CN201811211663.2A CN201811211663A CN109239057A CN 109239057 A CN109239057 A CN 109239057A CN 201811211663 A CN201811211663 A CN 201811211663A CN 109239057 A CN109239057 A CN 109239057A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/76—Chemiluminescence; Bioluminescence
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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Abstract
The invention discloses a kind of stable digoxin quality-control product, including matrix liquid, the digoxin of 0.4 μ of μ g/L ~ 3.0 g/L, protein protective agent, preservative and carbohydrate.Preparation method are as follows: a certain amount of glycerol is added in matrix liquid first, is formed after mixing and saves liquid；Then digoxin is added into preservation liquid, digoxin high level solution is obtained after mixing；Digoxin high level solution is diluted with matrix liquid, obtains the digoxin solution of high, medium and low various concentration；Definite value is carried out respectively with chemical illumination immunity analysis instrument；Protein protective agent, preservative and carbohydrate are added in high, medium and low concentration digoxin solution, and definite value is carried out to high, medium and low digoxin solution respectively with chemical illumination immunity analysis instrument, obtains high, medium and low digoxin quality-control product.Preparation method of the present invention is simple, and uniformity has good stability, not by transport, the factors such as temperature are influenced, and the performance of quality-control product is stablized.
Description
Technical field
The present invention relates to quality-control products, and more particularly, to a kind of stable digoxin quality-control product, the invention further relates to the Quality Controls
The preparation method of product.
Background technique
Digoxin is middle effect cardiac glycosides drug, and patient shows as positive inotropic action to action of the heart in treatment,
Can reducing heart rate, inhibit cardiac conduction.It is clinically widely used in treatment chronic cardiac insufficiency, auricular fibrillation and auricular flutter,
It is the drug of clinically routine monitoring blood concentration.Therapeutic drug monitoring has played very your writing in terms of poisoning by digoxin occurs in prevention
With.
Since digoxin is there are clinical application safe range is narrow, individual difference is big, and therapeutic dose and dosis toxica are overlapped
Pharmacokinetic properties just must make blood concentration caused by given maintenance dose normal to guarantee drug safety
Blood concentration within the scope of.The instrument and the reagent amount of progress used when can be to detection of drug concentration using digoxin quality-control product
The quality of change controls, and guarantees the accurate and reliable of testing result.
Summary of the invention
The purpose of the present invention is to provide a kind of stable digoxin quality-control products, and the present invention also provides the preparations of the quality-control product
Method.
To achieve the above object, the present invention can take following technical proposals:
Stable digoxin quality-control product of the present invention, including matrix liquid, the digoxin of 0.4 μ of μ g/L ~ 3.0 g/L, albumen are protected
Protect agent, preservative and carbohydrate.
The matrix liquid is normal human serum, human normal plasma, phosphate buffer, trishydroxymethylaminomethane salt buffer
One in liquid, borate buffer solution, citrate buffer, glycine-HCI buffer or phthalic acid-hydrochloride buffer
Kind.
The protein protective agent is one of aminopyrine, polyethylene glycol, gelatin or K30.
The preservative is Proclin300, gentamicin sulphate, NaN3, Bronidox, 1,2- benzisothiazole -3-
One of ketone, methylisothiazolinone are a variety of.
The carbohydrate is one of trehalose, sucrose, lactose and glucan.
The preparation method of digoxin quality-control product of the present invention includes the following steps:
1 ~ 10% glycerol is added in matrix liquid, is formed after mixing and saves liquid for the first step；Then high to addition ground in liquid is saved
It is pungent, the digoxin high level solution of 100000 μ of μ g/L ~ 10000000 g/L is obtained after mixing；
Second step obtains the digoxin of high, medium and low various concentration with the digoxin high level solution in the matrix liquid dilution first step
Solution；Definite value is carried out to high, medium and low digoxin solution respectively with chemical illumination immunity analysis instrument；
Protein protective agent, preservative and carbohydrate are added in high, medium and low concentration digoxin solution, and uses chemiluminescence for third step
Immunity analysis instrument carries out definite value to high, medium and low digoxin solution respectively, obtains high, medium and low digoxin quality-control product.
The advantage of the invention is that the digoxin quality-control product stable according to the performance that clinical practice demand is prepared, has non-
Often good Clinical practicability is especially advantageous for clinical popularization and development.Meanwhile preparation method of the present invention is simple, especially with
Normal human serum is consistent as matrix liquid with clinical sample matrix, can utmostly reduce matrix effect, and uniformly
Property, have good stability, not by transport, the factors such as temperature are influenced, and the performance of quality-control product is stablized.
The Internal Quality Control that quality-control product of the present invention can be used for each medical laboratory's digoxin project uses, and simultaneously can be used for room
Between quality evaluation organizer carry out digoxin 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 prepare high (3.0 μ g/L), in (1.0 μ g/L), low (0.4 μ g/L) three kinds of concentration digoxin Quality Control
Product, the specific steps are that:
The glycerol of 0.5mL is added in the first step in the normal human serum of 10mL, is formed after mixing and saves liquid；Add to saving in liquid
Enter 1mg digoxin, the digoxin high level solution of 1000000 μ g/L is obtained after mixing；
Second step, saving liquid to digoxin concentration with the normal human serum dilution of 50mL is 0.4 μ g/L, obtains low concentration digoxin
Solution；Saving liquid to digoxin concentration with the normal human serum dilution of 50mL is 1.0 μ g/L, obtains middle concentration digoxin solution；
Saving liquid to digoxin concentration with the normal human serum dilution of 50mL is 3.0 μ g/L, obtains Gaoxin solution in high concentration；And with entirely
Robotics luminescence immunoassay instrument to low concentration digoxin solution, middle concentration digoxin solution and in high concentration Gaoxin solution into
Row definite value；
Third step is separately added into 0.1% aminopyrine, 0.1% in the high, medium and low concentration digoxin solution that second step is prepared
Proclin300,0.1% gentamicin sulphate, 5% trehalose, and it is to low concentration high with Full-automatic chemiluminescence immunoassay analysis meter
Pungent solution, middle concentration digoxin solution and Gaoxin solution carries out definite value in high concentration, can be obtained high (3.0 μ g/L), in (1.0 μ g/
L), the stable digoxin quality-control product of low (0.4 μ g/L) three kinds of concentration.
When practical preparation, in addition to normal human serum, human normal plasma, phosphate buffer, three hydroxyls are also can be used in matrix liquid
Aminomethane salt buffer, borate buffer solution, citrate buffer, glycine-HCI buffer or O-phthalic
One of acid-hydrochloride buffer.
Equally, protein protective agent can also use polyethylene glycol, gelatin or K30；Preservative can also use NaN3、
One of Bronidox, 1,2-benzisothiazolin-3-one, methylisothiazolinone are a variety of；Carbohydrate also can be used sucrose,
Lactose or glucan.
The performance test of the quality-control product prepared by the present invention of embodiment 2
1, uniformity detects
Digoxin quality-control product prepared by embodiment 1 is detected using Full-automatic chemiluminescence immunoassay analysis meter.Each level
It is random to take out 10 bottles and random number 1-10, it detects 3 times respectively for every bottle on the detection system.Consider the measuring system factors such as at any time
Caused random variation, 3 measurements are adopted and are carried out in differing order, for example, 1,3,5,7,9,2,4,6,8,10,10,9,8,7,
6,5,4,3,2,1,2,4,6,8,10,1,3,5,7,9.Each level is evaluated with one-way analysis of variance (F inspection) to detection data
Uniformity, data are as follows:
1 uniformity testing result of table (μ g/L)
Interpretation of result:
Remarks: SSAlways: variance, MS: square.
It looks into F table and obtains critical valueF 0.05 (9,20)=2.39,3 horizontal homogeneity inspection results are shown: without bright between bottle in bottle
Significant difference is different, and digoxin quality-control product content prepared by example 1 is uniform.
2, Detection of Stability
2.1 corkage Detection of Stability
Digoxin quality-control product described in embodiment 1 is dispensed according to 1mL/ bottles, is saved after corkage in 2-8 DEG C, every 3
Its detection 1 time, is repeated 3 times every time, is averaged, and is carried out continuously 30 days and monitors, data are as follows:
2.2 effect phase Detection of Stability
Digoxin quality-control product described in embodiment 1 is dispensed according to 1mL/ bottles, saves in 0 DEG C or less, monthly measures 1 time, every time weight
It is 3 times multiple, it is averaged, data are as follows:
As can be seen from the above table, the digoxin quality-control product that prepared by embodiment 1 has good stability.
Claims (6)
1. a kind of stable digoxin quality-control product, it is characterised in that: the quality-control product includes matrix liquid, 0.4 μ of μ g/L ~ 3.0 g/L
Digoxin, protein protective agent, preservative and carbohydrate.
2. stable digoxin quality-control product according to claim 1, it is characterised in that: the matrix liquid is normal person's blood
Clearly, human normal plasma, phosphate buffer, trishydroxymethylaminomethane salt buffer, borate buffer solution, Citrate buffer
One of liquid, glycine-HCI buffer or phthalic acid-hydrochloride buffer.
3. stable digoxin quality-control product according to claim 1, it is characterised in that: the protein protective agent is amino ratio
One of woods, polyethylene glycol, gelatin or K30.
4. stable digoxin quality-control product according to claim 1, it is characterised in that: the preservative is
Proclin300, gentamicin sulphate, NaN3, Bronidox, 1,2-benzisothiazolin-3-one, in methylisothiazolinone
It is one or more.
5. stable digoxin quality-control product according to claim 1, it is characterised in that: the carbohydrate be trehalose, sucrose,
One of lactose and glucan.
6. the preparation method of digoxin quality-control product described in claim 1, it is characterised in that: include the following steps:
1 ~ 10% glycerol is added in matrix liquid, is formed after mixing and saves liquid for the first step；Then high to addition ground in liquid is saved
It is pungent, the digoxin high level solution of 100000 μ of μ g/L ~ 10000000 g/L is obtained after mixing；
Second step obtains the digoxin of high, medium and low various concentration with the digoxin high level solution in the matrix liquid dilution first step
Solution；Definite value is carried out to high, medium and low digoxin solution respectively with chemical illumination immunity analysis instrument；
Protein protective agent, preservative and carbohydrate are added in high, medium and low concentration digoxin solution, and uses chemiluminescence for third step
Immunity analysis instrument carries out definite value to high, medium and low digoxin solution respectively, obtains high, medium and low digoxin quality-control product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811211663.2A CN109239057A (en) | 2018-10-18 | 2018-10-18 | A kind of stable digoxin quality-control product and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811211663.2A CN109239057A (en) | 2018-10-18 | 2018-10-18 | A kind of stable digoxin quality-control product and preparation method |
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| CN109239057A true CN109239057A (en) | 2019-01-18 |
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| CN201811211663.2A Pending CN109239057A (en) | 2018-10-18 | 2018-10-18 | A kind of stable digoxin quality-control product and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109916682A (en) * | 2019-03-13 | 2019-06-21 | 郑州标源生物科技有限公司 | A kind of preparation method of Applications of Cardiac Markers quality-control product |
| CN110964783A (en) * | 2019-12-10 | 2020-04-07 | 郑州标源生物科技有限公司 | Quality control product of mitochondria aspartate aminotransferase and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102323419A (en) * | 2011-08-31 | 2012-01-18 | 内蒙古科慧生物科技有限责任公司 | Kit and detection method for quantitative determination of digoxin |
-
2018
- 2018-10-18 CN CN201811211663.2A patent/CN109239057A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102323419A (en) * | 2011-08-31 | 2012-01-18 | 内蒙古科慧生物科技有限责任公司 | Kit and detection method for quantitative determination of digoxin |
Non-Patent Citations (4)
| Title |
|---|
| 任华益: "《药学"三基"训练 上册 药学基础理论》", 30 April 2008 * |
| 凌树森: "《治疗药物监测新理论与新方法》", 30 April 2002 * |
| 孙东坡 等: "蛋白质冷冻干燥制品中的保护剂及其保护机制", 《药学进展》 * |
| 韩志钧: "《临床化学常用项目自动分析法》", 31 August 2005 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109916682A (en) * | 2019-03-13 | 2019-06-21 | 郑州标源生物科技有限公司 | A kind of preparation method of Applications of Cardiac Markers quality-control product |
| CN110964783A (en) * | 2019-12-10 | 2020-04-07 | 郑州标源生物科技有限公司 | Quality control product of mitochondria aspartate aminotransferase and preparation method thereof |
| CN110964783B (en) * | 2019-12-10 | 2023-08-29 | 郑州标源生物科技有限公司 | Quality control product of mitochondrial aspartic acid aminotransferase and preparation method thereof |
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