CN109100499A - A kind of formula of quality-control product freeze-drying liquid - Google Patents
A kind of formula of quality-control product freeze-drying liquid Download PDFInfo
- Publication number
- CN109100499A CN109100499A CN201810640644.5A CN201810640644A CN109100499A CN 109100499 A CN109100499 A CN 109100499A CN 201810640644 A CN201810640644 A CN 201810640644A CN 109100499 A CN109100499 A CN 109100499A
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- China
- Prior art keywords
- quality
- control product
- formula
- drying liquid
- freeze
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- 238000003908 quality control method Methods 0.000 title claims abstract description 30
- 238000004108 freeze drying Methods 0.000 title claims abstract description 20
- 239000007788 liquid Substances 0.000 title claims abstract description 20
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 12
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 11
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 10
- 239000003755 preservative agent Substances 0.000 claims abstract description 9
- 230000002335 preservative effect Effects 0.000 claims abstract description 9
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 9
- 102000004169 proteins and genes Human genes 0.000 claims abstract description 9
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 claims abstract description 6
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims abstract description 6
- 235000019301 disodium ethylene diamine tetraacetate Nutrition 0.000 claims abstract description 6
- 239000011780 sodium chloride Substances 0.000 claims abstract description 6
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims abstract description 5
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims abstract description 5
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims abstract description 5
- 229940089468 hydroxyethylpiperazine ethane sulfonic acid Drugs 0.000 claims abstract description 3
- JKMHFZQWWAIEOD-UHFFFAOYSA-N 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid Chemical compound OCC[NH+]1CCN(CCS([O-])(=O)=O)CC1 JKMHFZQWWAIEOD-UHFFFAOYSA-N 0.000 claims description 5
- 238000011010 flushing procedure Methods 0.000 claims 1
- 239000004615 ingredient Substances 0.000 abstract description 2
- 102000004190 Enzymes Human genes 0.000 description 4
- 108090000790 Enzymes Proteins 0.000 description 4
- 108010048233 Procalcitonin Proteins 0.000 description 3
- CWCXERYKLSEGEZ-KDKHKZEGSA-N procalcitonin Chemical compound C([C@@H](C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@H](C(=O)N[C@@H](C)C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](C(C)C)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)NCC(O)=O)[C@@H](C)O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCSC)NC(=O)[C@H]1NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)[C@@H](N)CSSC1)[C@@H](C)O)[C@@H](C)O)[C@@H](C)O)C1=CC=CC=C1 CWCXERYKLSEGEZ-KDKHKZEGSA-N 0.000 description 3
- 230000007812 deficiency Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000000338 in vitro Methods 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 241001474374 Blennius Species 0.000 description 1
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical class [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 description 1
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000008139 complexing agent Substances 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 229910001385 heavy metal Inorganic materials 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
Classifications
-
- 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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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Urology & Nephrology (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Biotechnology (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)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
The invention discloses a kind of formulas of quality-control product freeze-drying liquid, it is grouped as by the group that number calculates following by mass percentage: 0.2%~1%4- hydroxyethyl piperazineethanesulfonic acid, 0.4%~2% sodium chloride, 0.5%~5% protein reagent, 0.05%~0.4% disodium EDTA, two water, 0.2%~2% trehalose, 0.02%~0.2% preservative, remaining is water.For the present invention compared to existing product, the appearance plastotype of quality-control product is good, is not in wall built-up phenomenon, and quality-control product stability and homogeneity are good, ingredient is simple and easy to dissolve.
Description
Technical field: the invention belongs in vitro diagnostic reagent technical field, specifically a kind of quality-control product freeze-drying
The formula of liquid.
Background technique: freeze-dried powder is that drug field is that medical fluid is frozen into solid injection in an aseptic environment, in vitro
Dried frozen aquatic products after diagnosis industry freeze-drying liquid freeze-drying will have certain homogeneity, and the stability of dried frozen aquatic products can use well, but existing
With the presence of the very big deficiency of the freeze-drying liquid dried frozen aquatic products that are lyophilized out, quality-control product will appear appearance plastotype difference and hang after using
The ratio of briquetting of phenomena such as wall, freeze-dried powder are low, and stability and homogeneity are general in use, can not meet people to freeze-drying
The demand of liquid effect.
Summary of the invention:
The object of the present invention is to provide a kind of formulas of quality-control product freeze-drying liquid, to solve the deficiency of existing equipment.
A kind of formula of quality-control product freeze-drying liquid of the invention, is grouped as by the group that number calculates following by mass percentage:
0.2%~1%4- hydroxyethyl piperazineethanesulfonic acid, 0.4%~2% sodium chloride, 0.5%~5% protein reagent,
0.05%~0.4% disodium EDTA, two water, 0.2%~2% trehalose, 0.02%~0.2% preservative, remaining
For water.
Most preferably, the 4- hydroxyethyl piperazineethanesulfonic acid is buffer, maintains stable pH value.
Most preferably, the mass fraction of the 4- hydroxyethyl piperazineethanesulfonic acid is most preferably 0.48%.
Most preferably, the mass fraction of the sodium chloride is most preferably 0.88%.
Most preferably, the mass fraction of the protein reagent is most preferably 2%, and protein reagent is BSA, and BSA is enzyme
Stabilizer prevents the decomposition and non-specific adsorption of enzyme, after BSA is added, can play protection or carrier function, enzyme adds BSA
After its activity can be made to increase substantially.
Most preferably, the mass fraction of two water of disodium EDTA is most preferably 0.2%, ethylenediamine tetrem
Acid disodium salt is a kind of complexing agent, can be used for heavy-metal ion removal to the inhibiting effect of enzyme.
Most preferably, the mass fraction of the trehalose is most preferably 1%, and the stability of freeze-dried reagent can be improved, with
And form the shape of freeze-dried reagent more preferably, have the function of stable protein structure and resist drying.
Most preferably, the mass fraction of the preservative is most preferably 0.05%, and preservative is Proclin-300 anti-corrosion
Agent.
The beneficial effects of the present invention are: the present invention is compared to existing product, the appearance plastotype of quality-control product is good, is not in
Wall built-up phenomenon, and quality-control product stability and homogeneity are good, ingredient is simple and easy to dissolve.
Specific embodiment:
The present invention is further described below with reference to embodiment.
Embodiment 1
Liquid is lyophilized to prepare: the 4- hydroxyethyl piperazineethanesulfonic acid of 0.48% mass fraction, the sodium chloride of 0.88% mass fraction,
The protein reagent of 2% mass fraction, two water of disodium EDTA of 0.2% mass fraction, the seaweed of 1% mass fraction
Sugar, the Proclin-300 preservative of 0.05% mass fraction be dissolved in the water mass fraction be 100%, complete prepare.
Embodiment 2
Procalcitonin quality-control product: 2 sets of quality-control products of remelt, it is a set of to be accelerated stability, a set of 4 degree of placement 1-15 after doing remelt
The stability in week, quality-control product luminous value have no obvious drop range；
| Quality-control product QC1 | Quality-control product QC2 | |
| Incipient melting | 3364 | 483834 |
| 37 degree are placed 1 week | 3517 | 479901 |
| 4 degree are placed 1 week | 3431 | 477661 |
| 4 degree are placed 2 weeks | 3263 | 463331 |
| 4 degree are placed 3 weeks | 3195 | 467789 |
| 4 degree are placed 4 weeks | 3397 | 496767 |
| 4 degree are placed 5 weeks | 3498 | 458554 |
| 4 degree are placed 6 weeks | 3395 | 468108 |
| 4 degree are placed 7 weeks | 3229 | 491991 |
| 4 degree are placed 8 weeks | 3330 | 487214 |
| 4 degree are placed 9 weeks | 3532 | 501545 |
| 4 degree are placed 10 weeks | 3197 | 487214 |
| 4 degree are placed 11 weeks | 3534 | 477654 |
| 4 degree are placed 12 weeks | 3454 | 496788 |
| 4 degree are placed 13 weeks | 3403 | 485429 |
| 4 degree are placed 14 weeks | 3475 | 453778 |
| 4 degree are placed 15 weeks | 3582 | 483460 |
| Average value | 3392 | 480070 |
| CV | 4% | 3% |
Embodiment 3
Procalcitonin quality-control product: the quality-control product of this freeze-drying formula of liquid of 3 different batches is done, has no obvious difference between batch；
Embodiment 4
Procalcitonin quality-control product: the quality-control product of this freeze-drying formula of liquid between the different bottles an of batch is done, has no obvious batch
Between it is poor.
| Quality-control product QC1 | Quality-control product QC2 | |
| 1 | 3377 | 487790 |
| 2 | 3723 | 479890 |
| 3 | 3466 | 482445 |
| Average value | 3522 | 483375 |
| CV | 5% | 1% |
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, without departing from the technical principles of the invention, freeze-drying purpose is realized, other selections of the optimal accounting of component are also answered
It is considered as protection scope of the present invention.
Claims (8)
1. a kind of formula of quality-control product freeze-drying liquid, it is characterised in that: be grouped as by the group that number calculates following by mass percentage:
0.2%~1%4- hydroxyethyl piperazineethanesulfonic acid, 0.4%~2% sodium chloride, 0.5%~5% protein reagent, 0.05%~
0.4% disodium EDTA, two water, 0.2%~2% trehalose, 0.02%~0.2% preservative, remaining is water.
2. a kind of formula of quality-control product freeze-drying liquid according to claim 1, wherein the 4- hydroxyethyl piperazineethanesulfonic acid is slow
Fliud flushing maintains stable pH value.
3. a kind of formula of quality-control product freeze-drying liquid according to claim 1, wherein the matter of the 4- hydroxyethyl piperazineethanesulfonic acid
Measuring score is most preferably 0.48%.
4. the formula of liquid is lyophilized in a kind of quality-control product according to claim 1, wherein the mass fraction of sodium chloride is most preferably
0.88%.
5. a kind of formula of quality-control product freeze-drying liquid according to claim 1, wherein the mass fraction of the protein reagent is optimal
It is selected as 2%, and protein reagent is BSA.
6. a kind of formula of quality-control product freeze-drying liquid according to claim 1, wherein two water of the disodium EDTA
Mass fraction be most preferably 0.2%.
7. a kind of formula of quality-control product freeze-drying liquid according to claim 1, wherein the mass fraction of the trehalose is most preferably
It is 1%.
8. a kind of formula of quality-control product freeze-drying liquid according to claim 1, wherein the mass fraction of the preservative is most preferably
It is 0.05%, and preservative is Proclin-300 preservative.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810640644.5A CN109100499A (en) | 2018-06-21 | 2018-06-21 | A kind of formula of quality-control product freeze-drying liquid |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810640644.5A CN109100499A (en) | 2018-06-21 | 2018-06-21 | A kind of formula of quality-control product freeze-drying liquid |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109100499A true CN109100499A (en) | 2018-12-28 |
Family
ID=64844972
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810640644.5A Pending CN109100499A (en) | 2018-06-21 | 2018-06-21 | A kind of formula of quality-control product freeze-drying liquid |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109100499A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109900541A (en) * | 2018-12-29 | 2019-06-18 | 广东云天抗体生物科技有限公司 | One kind containing trehalose freeze-drying liquid and its application |
| CN114209662A (en) * | 2021-12-10 | 2022-03-22 | 南京浦光生物科技有限公司 | Method for preventing deliquescence of freeze-dried preparation, freeze-dried liquid and preparation method of freeze-dried liquid |
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| CN108089016A (en) * | 2017-12-01 | 2018-05-29 | 北京北检·新创源生物技术有限公司 | A kind of lyophilized quality-control product of stabilization |
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2018
- 2018-06-21 CN CN201810640644.5A patent/CN109100499A/en active Pending
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| CN102128917A (en) * | 2010-12-07 | 2011-07-20 | 江西特康科技有限公司 | Clinical biochemical quality control products and preparation process thereof |
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| CN114209662A (en) * | 2021-12-10 | 2022-03-22 | 南京浦光生物科技有限公司 | Method for preventing deliquescence of freeze-dried preparation, freeze-dried liquid and preparation method of freeze-dried liquid |
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