CN114688834A - Freeze-drying preparation method of plague FI antibody diagnostic product - Google Patents
Freeze-drying preparation method of plague FI antibody diagnostic product Download PDFInfo
- Publication number
- CN114688834A CN114688834A CN202210255138.0A CN202210255138A CN114688834A CN 114688834 A CN114688834 A CN 114688834A CN 202210255138 A CN202210255138 A CN 202210255138A CN 114688834 A CN114688834 A CN 114688834A
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- Prior art keywords
- vacuum
- cold trap
- drying
- water
- temperature
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- 206010035148 Plague Diseases 0.000 title claims abstract description 22
- 241000607479 Yersinia pestis Species 0.000 title claims abstract description 22
- 238000004108 freeze drying Methods 0.000 title claims abstract description 18
- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 239000012502 diagnostic product Substances 0.000 title claims abstract description 8
- 238000001035 drying Methods 0.000 claims abstract description 20
- 238000007710 freezing Methods 0.000 claims abstract description 8
- 230000008014 freezing Effects 0.000 claims abstract description 8
- 238000005057 refrigeration Methods 0.000 claims abstract description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 33
- 239000013078 crystal Substances 0.000 claims description 6
- 238000010981 drying operation Methods 0.000 claims description 3
- 229920002545 silicone oil Polymers 0.000 claims description 3
- 238000000859 sublimation Methods 0.000 claims description 3
- 230000008022 sublimation Effects 0.000 claims description 3
- 210000003743 erythrocyte Anatomy 0.000 abstract description 7
- 238000000034 method Methods 0.000 abstract description 6
- 239000003153 chemical reaction reagent Substances 0.000 abstract description 5
- 238000003745 diagnosis Methods 0.000 description 5
- 238000004321 preservation Methods 0.000 description 5
- 208000035473 Communicable disease Diseases 0.000 description 4
- 210000004027 cell Anatomy 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 239000013543 active substance Substances 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- 210000000601 blood cell Anatomy 0.000 description 2
- 238000004925 denaturation Methods 0.000 description 2
- 230000036425 denaturation Effects 0.000 description 2
- 230000002779 inactivation Effects 0.000 description 2
- 230000008520 organization Effects 0.000 description 2
- 230000003204 osmotic effect Effects 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 241000193830 Bacillus <bacterium> Species 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 239000003223 protective agent Substances 0.000 description 1
- 206010048282 zoonosis Diseases 0.000 description 1
Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
Abstract
The invention relates to a freeze-drying preparation method of a plague FI antibody diagnostic product, which is characterized by comprising the following steps: 1) pre-freezing; 2) cold trap preparation: starting a vacuum pump, wherein the vacuum does not reach a cold trap, the cold trap is also started for refrigeration, and the temperature of the laminate is kept at the previous set value; 3) vacuum of a cavity: respectively opening a valve between the cold trap and the vacuum pump and a valve between the cavity and the cold trap; once the vacuum degree of the cavity reaches a set value, the vacuum is kept at the value; according to the hardware configuration of the equipment, vacuum control is completed through a valve between the cold trap and the vacuum pump or an air leakage valve on the cavity; 4) primary drying; 5) and (5) secondary drying. The invention has the advantages that: the preparation method is convenient, the integrity of the red blood cells can be improved, the freeze-drying storage condition is optimized, the plague diagnostic reagent which is easy to store and transport and has long shelf life can be prepared, and new reagents do not need to be prepared every year, so that the workload is reduced, and the method has good popularization prospect and commercial value.
Description
Technical Field
The invention relates to a freeze-drying preparation method of a plague FI antibody diagnostic product.
Background
Plague is an acute virulent infectious disease of zoonosis caused by plague bacillus, and has the characteristics of acute morbidity, short disease course, strong infectivity, high mortality and the like. The infectious diseases control law of the people's republic of China lists plague as a class A infectious disease, and the world health organization lists plague as an international quarantine infectious disease. The earlier and faster the diagnosis, the greater the potential to control the spread of plague. At present, plague diagnosis methods are numerous, but plague serology is one of the most main standard diagnosis methods, the method has the advantages of simple operation, short time consumption and accurate and reliable result, is one of the recommended diagnosis methods of the world health organization, is used all the time in China, most of plague FI antibody sensitized blood cells for plague serology diagnosis prepared in Qinghai province are liquid preparations, no erythrocyte protective agent is added, the integrity of erythrocytes is not high, the effective period is short, the cells are 1 year, the cells are required to be stored in a refrigerator at 4 ℃, the cells are not suitable to be stored in special environments such as cold, dry heat and the like, long-distance transportation is easy to damage, and how to solve the problems becomes the research direction. The freeze drying preservation technology is a potential, effective and economic red blood cell long-term preservation method, and is widely applied to preservation of human red blood cells at present. The plague FI antibody sensitized blood cells prepared by the erythrocyte freeze-drying preservation technology prolong the effective period of the reagent on the premise of ensuring that the experiment requirements are met, are convenient to transport, do not need special preservation and can meet the field work requirements.
Disclosure of Invention
The invention aims to provide a freeze-drying preparation method of a plague FI antibody diagnostic product, which aims to solve the problems in the background technology.
In order to solve the technical problems, the technical scheme provided by the invention is as follows: a freeze-drying preparation method of a plague FI antibody diagnostic product is characterized by comprising the following steps:
1) pre-freezing: the equipment sets the temperature of the laminate according to the optimized freeze-drying condition and operates to the set temperature; after the operation reaches the set temperature, continuously keeping the set temperature for a certain time; the pre-freezing stage may also cause osmotic pressure changes, pH shift, etc. due to solute concentration, resulting in protein denaturation, active substance inactivation, and some chemical changes of the sample; therefore, the temperature setting at the stage is particularly critical to the pre-freezing time;
2) cold trap preparation: starting a vacuum pump, wherein the vacuum does not reach a cold trap, the cold trap is also started for refrigeration, and the temperature of the laminate is kept at the previous set value;
3) vacuum of a cavity: respectively opening a valve between the cold trap and the vacuum pump and a valve between the cavity and the cold trap; once the vacuum degree of the cavity reaches a set value, the vacuum is kept at the value; according to the hardware configuration of the equipment, vacuum control is completed through a valve between the cold trap and the vacuum pump or an air leakage valve on the cavity;
4) primary drying: performing main drying according to the set value of the optimized freeze-drying condition; at this stage, after prefreezing, the water is present in the following form: free water, adsorbed water, and bound water; removing free water corresponding to the primary drying in the later period; secondary drying, removing adsorbed water and bound water, primary drying, removing ice by a sublimation mode, and operating the temperature and vacuum numerical values to a set value at a limit speed; the system then maintains the set temperature and vacuum values until the user changes the set values;
5) secondary drying: this option performs a secondary drying operation; removing the absorbed water and the crystal water of the amorphous phase, and reducing the absorbed water and the crystal water from 20% to 1%; starting the electric heater and the silicone oil circulating pump, and enabling the temperature of the laminate to reach and maintain a laminate temperature set value; at this stage, the vacuum is not controlled, but to a limit value.
The invention has the advantages that: the preparation method is convenient, the integrity of the red blood cells can be improved, the freeze-drying storage condition is optimized, the plague diagnostic reagent which is easy to store and transport and has long shelf life can be prepared, and new reagents do not need to be prepared every year, so that the workload is reduced, the storage condition does not need to be considered in the detection of plague laboratories or the field fixed monitoring of plague, and the popularization prospect and the commercial value are good.
Detailed Description
The invention is illustrated below by means of specific examples, without being restricted thereto.
Examples
A freeze-drying preparation method of a plague FI antibody diagnostic product is characterized by comprising the following steps:
1) pre-freezing: the equipment sets the temperature of the laminate according to the optimized freeze-drying condition and operates to the set temperature; after the operation reaches the set temperature, continuously keeping the set temperature for a certain time; the pre-freezing stage may also cause osmotic pressure changes, pH shift, etc. due to solute concentration, resulting in protein denaturation, active substance inactivation, and some chemical changes of the sample; therefore, the temperature setting and pre-freezing time at the stage are particularly critical;
2) cold trap preparation: starting a vacuum pump, wherein the vacuum does not reach a cold trap, the cold trap is also started for refrigeration, and the temperature of the laminate is kept at the previous set value;
3) vacuum of a cavity: respectively opening a valve between the cold trap and the vacuum pump and a valve between the cavity and the cold trap; once the vacuum degree of the cavity reaches a set value, the vacuum is kept at the value; according to the hardware configuration of the equipment, vacuum control is completed through a valve between the cold trap and the vacuum pump or an air leakage valve on the cavity;
4) primary drying: performing main drying according to the set value of the optimized freeze-drying condition; at this stage, after prefreezing, the water is present in the following form: free water, adsorbed water, and bound water; removing free water corresponding to the primary drying in the later period; secondary drying, removing adsorbed water and bound water, primary drying, removing ice by a sublimation mode, and operating the temperature and vacuum numerical values to a set value at a limit speed; the system then maintains the set temperature and vacuum values until the user changes the set values;
5) secondary drying: this option performs a secondary drying operation; removing the absorbed water and the crystal water of the amorphous phase, and reducing the absorbed water and the crystal water from 20% to 1%; starting the electric heater and the silicone oil circulating pump, and enabling the temperature of the laminate to reach and maintain a laminate temperature set value; at this stage, the vacuum is not controlled, but reaches a limit value.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.
Claims (1)
1. A freeze-drying preparation method of a plague FI antibody diagnostic product is characterized by comprising the following steps:
1) pre-freezing: the equipment sets the temperature of the laminate according to the optimized freeze-drying conditions and operates to the set temperature; after the operation reaches the set temperature, continuously keeping the set temperature for a certain time;
2) cold trap preparation: starting a vacuum pump, wherein the vacuum does not reach a cold trap, the cold trap is also started for refrigeration, and the temperature of the laminate is kept at the previous set value;
3) vacuum of a cavity: respectively opening a valve between the cold trap and the vacuum pump and a valve between the cavity and the cold trap; once the vacuum degree of the cavity reaches a set value, the vacuum is kept at the value; according to the hardware configuration of the equipment, vacuum control is completed through a valve between the cold trap and the vacuum pump or an air leakage valve on the cavity;
4) primary drying: performing main drying according to a set value input by optimized freeze-drying conditions; at this stage, after prefreezing, the water is present in the following form: free water, adsorbed water, and bound water; removing free water corresponding to the primary drying in the later period; secondary drying, removing adsorbed water and bound water, primary drying, removing ice by a sublimation mode, and operating the temperature and vacuum numerical values to a set value at a limit speed; the system then maintains the set temperature and vacuum values until the user changes the set values;
5) secondary drying: this option performs a secondary drying operation; removing the absorbed water and the crystal water of the amorphous phase, and reducing the absorbed water and the crystal water from 20% to 1%; starting the electric heater and the silicone oil circulating pump, and enabling the temperature of the laminate to reach and maintain a laminate temperature set value; at this stage, the vacuum is not controlled, but to a limit value.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210255138.0A CN114688834A (en) | 2022-03-15 | 2022-03-15 | Freeze-drying preparation method of plague FI antibody diagnostic product |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210255138.0A CN114688834A (en) | 2022-03-15 | 2022-03-15 | Freeze-drying preparation method of plague FI antibody diagnostic product |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114688834A true CN114688834A (en) | 2022-07-01 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210255138.0A Pending CN114688834A (en) | 2022-03-15 | 2022-03-15 | Freeze-drying preparation method of plague FI antibody diagnostic product |
Country Status (1)
| Country | Link |
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| CN (1) | CN114688834A (en) |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002162160A (en) * | 2000-11-22 | 2002-06-07 | Airaa Chino:Kk | Freezing dryer |
| JP2005224219A (en) * | 2004-02-16 | 2005-08-25 | Toyo Kohan Co Ltd | Spongy body, cell-culturing medium and method for producing them |
| CN101196366A (en) * | 2006-12-07 | 2008-06-11 | 上海理工大学 | Low-temperature freeze dryer for experiment |
| CN101614469A (en) * | 2009-07-30 | 2009-12-30 | 上海东富龙科技股份有限公司 | A kind of full-automatic intelligent vacuum freeze dryer |
| CN101680714A (en) * | 2007-06-14 | 2010-03-24 | 株式会社爱发科 | Vacuum freeze-drying apparatus and method of vacuum freeze drying |
| CN102091045A (en) * | 2010-12-30 | 2011-06-15 | 江苏奥赛康药业有限公司 | Hydrochloride diltiazem composition for injection and preparation method thereof |
| CN104880035A (en) * | 2015-04-16 | 2015-09-02 | 青岛永合创信电子科技有限公司 | Small vacuum freezing dryer with two cold traps |
| KR101821261B1 (en) * | 2017-02-07 | 2018-01-24 | 주식회사 오페론어드밴텍 | Lyophilization equipment |
| CN210569543U (en) * | 2019-10-14 | 2020-05-19 | 广州御延堂生物科技有限公司 | Freeze dryer |
-
2022
- 2022-03-15 CN CN202210255138.0A patent/CN114688834A/en active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002162160A (en) * | 2000-11-22 | 2002-06-07 | Airaa Chino:Kk | Freezing dryer |
| JP2005224219A (en) * | 2004-02-16 | 2005-08-25 | Toyo Kohan Co Ltd | Spongy body, cell-culturing medium and method for producing them |
| CN101196366A (en) * | 2006-12-07 | 2008-06-11 | 上海理工大学 | Low-temperature freeze dryer for experiment |
| CN101680714A (en) * | 2007-06-14 | 2010-03-24 | 株式会社爱发科 | Vacuum freeze-drying apparatus and method of vacuum freeze drying |
| CN101614469A (en) * | 2009-07-30 | 2009-12-30 | 上海东富龙科技股份有限公司 | A kind of full-automatic intelligent vacuum freeze dryer |
| CN102091045A (en) * | 2010-12-30 | 2011-06-15 | 江苏奥赛康药业有限公司 | Hydrochloride diltiazem composition for injection and preparation method thereof |
| CN104880035A (en) * | 2015-04-16 | 2015-09-02 | 青岛永合创信电子科技有限公司 | Small vacuum freezing dryer with two cold traps |
| KR101821261B1 (en) * | 2017-02-07 | 2018-01-24 | 주식회사 오페론어드밴텍 | Lyophilization equipment |
| CN210569543U (en) * | 2019-10-14 | 2020-05-19 | 广州御延堂生物科技有限公司 | Freeze dryer |
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Application publication date: 20220701 |
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