CN104946616A - General solid stabilizer used for in vitro diagnostic reagent and application method of general solid stabilizer - Google Patents
General solid stabilizer used for in vitro diagnostic reagent and application method of general solid stabilizer Download PDFInfo
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- CN104946616A CN104946616A CN201510238992.6A CN201510238992A CN104946616A CN 104946616 A CN104946616 A CN 104946616A CN 201510238992 A CN201510238992 A CN 201510238992A CN 104946616 A CN104946616 A CN 104946616A
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- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
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- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
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Abstract
The invention provides a general solid stabilizer used for an in vitro diagnostic reagent and an application method of the general solid stabilizer. The general solid stabilizer used for the in vitro diagnostic reagent is characterized by being obtained by lyophilizing raw material aqueous solution, wherein the raw material aqueous solution contains 5-20g/L of bovine serum albumin, 2-15mmol/L of EDTA sodium salt or EDTA potassium salt, 10-20g/L of sucrose or glycine or mannose, 0.1-1g/L of Tween 20 or Tween 40 or Tween 80 or polyvinylpyrrolidone, 1-5g/L of cyclodextrin and 1-5g/L of PEG2000 or PEG6000 or PEG8000. The general solid stabilizer used for the in vitro diagnostic reagent has the advantages that retention time of a reagent can be effectively prolonged, and detection results of the reagent can be stable; besides, the general solid stabilizer used for the in vitro diagnostic reagent is solid, can be stored at normal temperature and is simple and convenient to use.
Description
Technical field
The present invention relates to the general solid stablizer for external diagnosis reagent.
Background technology
The external diagnosis reagent case used clinically is at present mostly containing materials such as enzyme, labile look source, coenzyme, external diagnosis reagent case containing enzyme, most enzyme reagent thermostability is bad, need preserve at 2 ~ 10 DEG C, some enzyme reagent as genetic engineering then need be preserved at-20 DEG C, because enzyme is preserved for a long time easily lose part or all of vigor by temperature, pH of buffer, liquid, cause test kit quality stability to decline or lost efficacy, thus directly having influence on the inaccurate of clinical sample measurement result and mistaken diagnosis.In addition coenzyme, look source etc. are also by the impact of temperature, pH of buffer, liquid long-term storage conditions, easily decompose and cause test kit instability or lost efficacy.
At present about the report of the stability of external diagnosis reagent case be all for stability single of enzyme affect stability because usually considering.A kind of one package stabilizer for Glucose estimation kit that patent CN104195221A mentions; Patent CN200510111883.4 provides a kind of enzyme combining stabilizer and is just studied the stability of several specific single enzyme, does not embody playing a role other unstable constituents comprehensive stabilities of test kit; These stablizers are all liquid component in addition, are not easy to long-term storage and transport.Therefore research and develop a kind of general Pickering agent, external diagnosis reagent case is had to the stablizer of wide spectrum stabilization, be necessary very much.
Summary of the invention
The object of this invention is to provide a kind of general solid stablizer, for external diagnosis reagent, the external diagnosis reagent especially containing unstable constituentss such as enzyme, labile look source or coenzyme, this stablizer is solid, is convenient to long-term preservation, transport and use.
In order to achieve the above object, the invention provides a kind of general solid stablizer for external diagnosis reagent, it is characterized in that, obtain by after aqueous solution of raw material freeze-drying, described aqueous solution of raw material comprises 5-20g/L bovine serum albumin, 2-15mmol/L EDETATE SODIUM salt or EDTA sylvite, 10-20g/L sucrose or glycine or seminose, 0.1-1g/L polysorbas20 or polysorbate40 or tween 80 or polyvinylpyrrolidone, 1-5g/L cyclodextrin and 1-5g/L PEG2000 or PEG6000 or PEG8000.
Preferably, at least one in R1 and the R2 reagent that described external diagnosis reagent is R1 and the R2 reagent in tolal bile acid determination reagent box (Enzymatic cycling), the R2 reagent in R1 and the R2 reagent in creatinine assay test kit (enzyme process), fucoside enzyme reagent kit (CNPF substrate method), high/low density measure R1 and R2 reagent in test kit (homogeneous method) and Creatine kinase MB (CK-MB) measures in test kit.
Present invention also offers the using method of the above-mentioned general solid stablizer for external diagnosis reagent, it is characterized in that, comprise and join in external diagnosis reagent by the above-mentioned general solid stablizer being used for external diagnosis reagent, the described weight of general solid stablizer and the ratio of the volume of external diagnosis reagent are 0.1-1g/L.
Compared with prior art, the invention has the beneficial effects as follows:
The present invention effectively can extend the shelf time of reagent, and the detected result of described reagent can be made more stable.This stablizer is solid in addition, can preserve by normal temperature, easy to use.
Embodiment
Below in conjunction with specific embodiment, set forth the present invention further.Should be understood that these embodiments are only not used in for illustration of the present invention to limit the scope of the invention.In addition should be understood that those skilled in the art can make various changes or modifications the present invention, and these equivalent form of values fall within the application's appended claims limited range equally after the content of having read the present invention's instruction.
R1 and R2 reagent in R2 reagent in R1 and R2 reagent in tolal bile acid determination reagent box (Enzymatic cycling) used in following embodiment, R1 and the R2 reagent in creatinine assay test kit (enzyme process), fucoside enzyme reagent kit (CNPF substrate method), high/low density mensuration test kit (homogeneous method) and Creatine kinase MB (CK-MB) R1 and the R2 reagent measured in test kit are all commercially available prod, are produced by Jun Shi biotechnology (Shanghai) Co., Ltd..
Embodiment
For a general solid stablizer for external diagnosis reagent, obtain by after aqueous solution of raw material freeze-drying, the component of described aqueous solution of raw material and concentration corresponding to each component as follows:
| Component | Concentration |
| Bovine serum albumin | 5g/L |
| EDETATE DISODIUM | 15mmol/L |
| Sucrose | 10g/L |
| Tween 80 | 1g/L |
| Polyvinylpyrrolidone | 1g/L |
| Cyclodextrin | 5g/L |
| PEG2000 | 5g/L |
The preparation method of the described general solid stablizer for external diagnosis reagent is: after said components at normal temperatures purified water stirring and dissolving, filters, obtains aqueous solution of raw material, then freeze-drying, can obtain the general solid stablizer for external diagnosis reagent.
Respectively the above-mentioned general solid stablizer being used for external diagnosis reagent is joined TOTAL BILE ACID (TBA) and measure R1 and R2 reagent in test kit (Enzymatic cycling), creatinine (CRE) measures R1 and the R2 reagent in test kit (enzyme process), R2 reagent in fucosidase (AFU) test kit (CNPF substrate method), high/low density (HDL-C/LDL-C) measures R1 and R2 reagent in test kit (homogeneous method) and Creatine kinase MB (CK-MB) measures in R1 and the R2 reagent in test kit, the ratio of the weight of described general solid stablizer and the volume of each external diagnosis reagent is 0.1g/L.Get simultaneously do not add general solid stablizer each external diagnosis reagent in contrast.
Get corresponding quality control product and carry out following measuring stability respectively:
Above-mentioned each quality control product is respectively RANDOX, ROCHE, Bole company, the real biological production of fine horse.Quality control product is divided into Quality Control 1 (normal value) and Quality Control 2 (pathology value) 2 concentration.
International clinical chemistry association is the sample or the solution that are specifically designed to quality control object to quality control product definition, can not be used for calibration.Require high to difference between stability, bottle.Divide definite value and underrange two kinds.When selecting control product, should select several concentration, concentration range wider distribution, preferably medical science decision level, the quality control product that has Reportable range scope to be upper lower limit value.
Landau biochemistry quality control product comprise TBA (definite value) project; Roche routine biochemistry quality control product comprises CRE (definite value) project; The lipid quality control product that Bole company produces comprises HDL/LDL (definite value) project; Landau company produces the special quality control product of CK-MB (definite value).
(1), 2-8 degree stability test:
Hitachi 7600 automatic clinical chemistry analyzer adopt Quality Control 1 and Quality Control 2 to measure according to each test kit specification sheets.
2-8 degree result
Can be analyzed by upper table data, the kit measurement quality control product not adding and add stablizer under 2-8 degree preservation condition does not have difference substantially.
Stability test in (2) 37 DEG C, 5 days: the above-mentioned each external diagnosis reagent adding Pickering agent and do not add Pickering agent was put into 37 DEG C of biochemical cultivation cases after 5 days simultaneously, on Hitachi 7600 automatic clinical chemistry analyzer, measure quality control product respectively at 37 DEG C according to each test kit specification sheets, result is as follows:
37 degree of 5 days results
Can be analyzed by upper table data, can analyze in 37 degree of placements, 5 days measurement results, the test kit quality control product adding stablizer measures the test kit being obviously better than not adding.
(3) 12 month long-term stable experiments:
The above-mentioned each external diagnosis reagent adding Pickering agent and do not add Pickering agent is put into 2-8 degree environment 12 months, its stability of results of regular determination simultaneously, and result is as follows:
By upper table interpretation of result, the permanent stability adding the reagent of stablizer are better than the reagent not adding stablizer, and from Quality Control, the quality control product not adding the reagent of stablizer is out of control at 12 months, not up to standard.Therefore the stability that stablizer can improve reagent is added.
Source stability of checking colors is tested:
Test kit AFU/HDL/LDL contains coloured source, respectively at reagent A FU:R2; HDL/LDL-C:R1; Add stablizer in CRE:R1 and do not add stablizer, carry out stability test in above-mentioned 37 DEG C, 5 days, test-results is as follows:
By upper table interpretation of result, do not add the test kit of stablizer, Quality Control declines.
To the stability test of coenzyme, test kit TBA:R1; CK-MB:R2 is respectively containing coenzyme, and at the reagent TBA:R1 containing coenzyme, add stablizer and do not add stablizer in CK-MB:R2, carry out stability test in above-mentioned 37 DEG C, 5 days, test-results is as follows:
The above-mentioned general solid stablizer for external diagnosis reagent is adopted to measure its permanent stability under room temperature preservation condition, at room temperature preserve after 12 months, join in R1 and the R2 reagent in TBA and CRE test kit, carry out stability test in above-mentioned 37 DEG C, 5 days, prove the stability of stablizer, result is as follows:
As can be seen from the above table, stablizer is in room temperature preservation after 12 months, and join in test kit, stabilizing effect does not change.
Claims (3)
1. the general solid stablizer for external diagnosis reagent, it is characterized in that, obtain by after aqueous solution of raw material freeze-drying, described aqueous solution of raw material comprises 5-20g/L bovine serum albumin, 2-15mmol/L EDETATE SODIUM salt or EDTA sylvite, 10-20g/L sucrose or glycine or seminose, 0.1-1g/L polysorbas20 or polysorbate40 or tween 80 or polyvinylpyrrolidone, 1-5g/L cyclodextrin and 1-5g/L PEG2000 or PEG6000 or PEG8000.
2. as claimed in claim 1 for the general solid stablizer of external diagnosis reagent, it is characterized in that, described external diagnosis reagent is at least one in R1 and the R2 reagent in the R2 reagent in R1 and the R2 reagent in tolal bile acid determination reagent box, R1 and the R2 reagent in creatinine assay test kit, fucoside enzyme reagent kit, R1 and the R2 reagent in high/low density mensuration test kit and Creatine kinase MB mensuration test kit.
3. the using method of the general solid stablizer for external diagnosis reagent according to claim 1, it is characterized in that, comprise and join in external diagnosis reagent by the general solid stablizer for external diagnosis reagent according to claim 1, the described weight of general solid stablizer and the ratio of the volume of external diagnosis reagent are 0.1-1g/L.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105603049A (en) * | 2016-01-18 | 2016-05-25 | 沈阳百创特生物科技有限公司 | Compound stabilizer and kit for in vitro diagnosis reagents |
| CN106282308A (en) * | 2016-08-29 | 2017-01-04 | 湖南海源医疗科技有限公司 | A kind of in-vitro diagnosis biochemical reagents stabilizer |
| CN106399459A (en) * | 2016-09-30 | 2017-02-15 | 广州鸿琪光学仪器科技有限公司 | Vaginal secretion detection kit and preparation method thereof |
| CN106568976A (en) * | 2016-11-04 | 2017-04-19 | 江苏福隆生物技术有限公司 | Neuron-specific enolase stabilizer and preparation method thereof |
| CN109856383A (en) * | 2019-03-05 | 2019-06-07 | 湖北泰康医疗设备有限公司 | A kind of immunochemistry staining kit for cervical carcinoma auxiliary diagnosis |
| CN111537736A (en) * | 2020-05-18 | 2020-08-14 | 中国农业大学 | Indirect ELISA (enzyme-linked immunosorbent assay) detection kit and detection method for mycoplasma gallisepticum antibody |
| CN111826417A (en) * | 2020-08-04 | 2020-10-27 | 武汉生之源生物科技股份有限公司 | N-acetyl-beta-D-glucosaminidase detection kit with good stability, preparation method and application |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1986785A (en) * | 2005-12-23 | 2007-06-27 | 上海复星长征医学科学有限公司 | Enzyme combining stabilizer |
| CN101553504A (en) * | 2006-12-11 | 2009-10-07 | 豪夫迈·罗氏有限公司 | Abeta antibody parenteral formulation |
| CN104195222A (en) * | 2014-08-18 | 2014-12-10 | 苏州康铭诚业医用科技有限公司 | Compound stabilizer for total cholesterol measurement kits |
-
2015
- 2015-05-12 CN CN201510238992.6A patent/CN104946616A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1986785A (en) * | 2005-12-23 | 2007-06-27 | 上海复星长征医学科学有限公司 | Enzyme combining stabilizer |
| CN101553504A (en) * | 2006-12-11 | 2009-10-07 | 豪夫迈·罗氏有限公司 | Abeta antibody parenteral formulation |
| CN104195222A (en) * | 2014-08-18 | 2014-12-10 | 苏州康铭诚业医用科技有限公司 | Compound stabilizer for total cholesterol measurement kits |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105603049A (en) * | 2016-01-18 | 2016-05-25 | 沈阳百创特生物科技有限公司 | Compound stabilizer and kit for in vitro diagnosis reagents |
| CN105603049B (en) * | 2016-01-18 | 2017-03-15 | 沈阳百创特生物科技有限公司 | A kind of compound stabilizer and kit for external diagnosis reagent |
| CN106282308A (en) * | 2016-08-29 | 2017-01-04 | 湖南海源医疗科技有限公司 | A kind of in-vitro diagnosis biochemical reagents stabilizer |
| CN106399459A (en) * | 2016-09-30 | 2017-02-15 | 广州鸿琪光学仪器科技有限公司 | Vaginal secretion detection kit and preparation method thereof |
| CN106568976A (en) * | 2016-11-04 | 2017-04-19 | 江苏福隆生物技术有限公司 | Neuron-specific enolase stabilizer and preparation method thereof |
| CN106568976B (en) * | 2016-11-04 | 2018-05-22 | 江苏福隆生物技术有限公司 | A kind of neuronspecific enolase stabilizer and preparation method thereof |
| CN109856383A (en) * | 2019-03-05 | 2019-06-07 | 湖北泰康医疗设备有限公司 | A kind of immunochemistry staining kit for cervical carcinoma auxiliary diagnosis |
| CN111537736A (en) * | 2020-05-18 | 2020-08-14 | 中国农业大学 | Indirect ELISA (enzyme-linked immunosorbent assay) detection kit and detection method for mycoplasma gallisepticum antibody |
| CN111826417A (en) * | 2020-08-04 | 2020-10-27 | 武汉生之源生物科技股份有限公司 | N-acetyl-beta-D-glucosaminidase detection kit with good stability, preparation method and application |
| CN111826417B (en) * | 2020-08-04 | 2023-01-17 | 武汉生之源生物科技股份有限公司 | N-acetyl-beta-D-glucosaminidase detection kit with good stability, preparation method and application |
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Application publication date: 20150930 |