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A kind of preparation technology of detecting new coronavirus freeze-dried powder

A technology of freeze-dried powder and preparation process, which is applied in the field of detection of new coronaviruses, can solve the problems of difficult removal of product moisture, easy collapse and shrinkage of the structure, and low pass rate, and achieves satisfactory performance of negative and positive coincidence rates, shortens freeze-drying time, The effect of low residual moisture

Active Publication Date: 2022-02-18
上海捷诺圣华生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the problems that the freeze-dried powder reaction reagents in the existing novel coronavirus detection kits have a low qualified rate in actual industrial production, the product moisture is difficult to remove, the structure is easy to collapse and shrink, and the freeze-drying cycle is long, etc., the present invention provides an industrial large-scale Production, high product qualification rate, shortened freeze-drying time, stable product quality and performance of the preparation process for the detection of new coronavirus freeze-dried powder

Method used

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  • A kind of preparation technology of detecting new coronavirus freeze-dried powder
  • A kind of preparation technology of detecting new coronavirus freeze-dried powder

Examples

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Effect test

Embodiment 1

[0032] Place the eight-tube pre-freeze-dried product on the hollowed-out freeze-drying mold in the freeze-dryer in a half-jammed state, and use convective heat transfer to freeze-dry: (1) During freezing control, the temperature drops to - within 60 minutes Keep at 45°C for 2 hours, so that the water in the product is completely frozen; (2) When drying once, vacuumize to 0.2mbar within 2min, and keep at -45°C for 30min; then keep the vacuum at 0.2mbar, within 20min Raise the temperature to -32°C and keep it for 960 minutes; (3) When analyzing and drying, in an environment with a vacuum degree below 0.39mbar, the temperature is raised to 20°C within 100min and kept for 2h; the vacuum is evacuated to 0mbar within 2min and kept for 10min. After analysis and drying, carry out negative pressure plugging under the condition of extreme vacuum in the freeze dryer, and after the plugging is completed, take out the material and store it at a low temperature of 2-8°C.

Embodiment 2

[0034] Place the eight-tube pre-freeze-dried product on the hollowed-out freeze-drying mold in the freeze-dryer in a half-jammed state, and use convective heat transfer to freeze-dry: (1) During freezing control, the temperature drops to - within 60 minutes Keep at 45°C for 2 hours, so that the water in the product is completely frozen; (2) When drying once, vacuumize to 0.2mbar within 2min, and keep at -45°C for 30min; then keep the vacuum at 0.2mbar, within 20min Raise the temperature to -32°C and keep it for 1110min; (3) When analyzing and drying, in an environment with a vacuum degree below 0.39mbar, the temperature is raised to 20°C within 100min, and keep for 2h; vacuumize to 0mbar within 2min, and keep for 10min. After analysis and drying, carry out negative pressure plugging under the condition of extreme vacuum in the freeze dryer, and after the plugging is completed, take out the material and store it at a low temperature of 2-8°C.

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Abstract

The invention discloses a preparation process of a freeze-dried powder for detecting the new coronavirus, which includes the following steps of freeze-drying: (1) Freeze control: place the pre-lyophilized product in a freeze dryer to freeze at T1 temperature, so that the pre-freeze-dried product The moisture in the freeze-dried product is completely frozen; (2) primary drying: including 2 stages, the first stage is under vacuum state, keep at T1 for 20-60min; the second stage is under vacuum state, heat up to -32°C and Keep for 16‑19 hours; (3) Analytical drying: raise the temperature in a vacuum environment according to preset conditions, and keep for 2 to 3 hours until the residual moisture in the freeze-dried product is controlled at 0.1‑4%. The freeze-drying process for detecting the freeze-dried powder of the new coronavirus provided by the present invention is suitable for large-scale industrial production, has a high qualified rate of products, can shorten the freeze-drying time, and saves costs. The freeze-dried powder for detecting the new coronavirus prepared by this process has a complete and uniform appearance without collapse, low residual moisture, stable performance, and can be transported over long distances or stored for a long time.

Description

technical field [0001] The invention relates to the technical field of novel coronavirus detection, in particular to a preparation process for detecting a novel coronavirus freeze-dried powder. Background technique [0002] The detection methods of the new coronavirus mainly include nucleic acid detection, antibody detection, antigen detection and other methods. Nucleic acid detection is currently the "gold standard" for the detection of new coronaviruses, which has the characteristics of early diagnosis, high sensitivity and specificity. In order to help the quarantine and prevention and control of the pneumonia epidemic caused by the new coronavirus, since the outbreak, nucleic acid detection kits for the new coronavirus have emerged at home and abroad. There are two commonly used nucleic acid diagnostic methods for the new coronavirus: viral nucleic acid specific Genetic testing and viral genome sequencing. The most common method for detecting novel coronavirus-specific...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12Q1/70C12Q1/6806C12R1/93
CPCC12Q1/701C12Q1/6806
Inventor 陆陈杰夏小凯朱丽媛程天龄杜金凤
Owner 上海捷诺圣华生物科技有限公司
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