Preparation process of freeze-dried powder for detecting novel coronavirus

A technology of freeze-dried powder and preparation process, applied in the field of new coronavirus detection, can solve the problems of difficult removal of product moisture, easy collapse and shrinkage of the structure, long freeze-drying cycle, etc., to meet the performance of the positive and negative coincidence rate, and shorten the freeze-drying time. , the effect of high pass rate

Active Publication Date: 2021-04-09
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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  • Preparation process of freeze-dried powder for detecting novel coronavirus
  • Preparation process of freeze-dried powder for detecting novel coronavirus
  • Preparation process of freeze-dried powder for detecting novel coronavirus

Examples

Experimental program
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Embodiment 1

[0033] 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 the convective heat transfer method 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 960min; (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; within 2min, the vacuum is evacuated to 0mbar 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

[0035] 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 the convective heat transfer method 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 kept for 2h; within 2min, the vacuum is evacuated to 0mbar 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.

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Abstract

The invention discloses a preparation process of freeze-dried powder for detecting novel coronavirus. The preparation process comprises the following freeze-drying steps: (1) freezing control: a pre-freeze-dried product is put into a freeze dryer, and frozen at T1 temperature to completely freeze water in the pre-freeze-dried product; (2) primary drying: two stages are included, the first stage is in a vacuum state, and the state is maintained for 20-60 min at T1; and the second stage is in a vacuum state, the temperature is increased to subzero 32 DEG C and kept for 16-19 h; and (3) desorbing and drying: the temperature is increased in a vacuum environment according to preset conditions, and kept for 2-3 h until the residual moisture in the freeze-dried product is controlled to be 0.1%-4%. The freeze-drying process of the freeze-dried powder for detecting novel coronavirus is suitable for industrial mass production, the yield of the obtained product is high, the freeze-drying time can be shortened, and the cost is saved. The freeze-dried powder for detecting the novel coronavirus, prepared by the process, is complete and uniform in appearance, free of collapse, low in residual water content and stable in performance, and can be transported for a long distance 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 Applications(China)
IPC IPC(8): C12Q1/70C12Q1/6806C12R1/93
CPCC12Q1/701C12Q1/6806C12Q2527/101C12Q2527/125
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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