Method for rapidly extracting plasma of COVID-19 patient in rehabilitation period by automatic separation system

A COVID-19, separation system technology, applied in the preparation methods of peptides, chemical instruments and methods, from serum immunoglobulins, etc., can solve the problems of donors' intolerance of blood collection activities and unfavorable donors' plasma collection work.

Active Publication Date: 2021-01-15
深圳博雅感知药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method has great limitations: first, donors need to go to a single blood collection station for registration, which is not conducive to donors in remote areas for plasma collection; second, during the plasma collection process, donors need to inject blood anticoagulants In order to prevent the collected blood from clotting outside the body; moreover, the collection time of blood components is generally 2 to 3 hours. During the process of blood collection and blood separation, the donor needs to maintain a fixed posture throughout the process. The relatively long time makes some donors unable to bear It is also one of the main reasons for blood collection failure

Method used

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  • Method for rapidly extracting plasma of COVID-19 patient in rehabilitation period by automatic separation system
  • Method for rapidly extracting plasma of COVID-19 patient in rehabilitation period by automatic separation system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Example 1, rapid separation of plasma from convalescent patients with COVID-19

[0054] 1. Peripheral blood (more than 250mL) donated by a COVID-19 patient (in this paper, the patient is marked as patient X) collected by venipuncture during the recovery period is placed in a blood collection bag (the collection bag is filled with anticoagulant citrate Natrate), put the blood collection bag on a horizontal shaker and mix well for 15 minutes; Recovered persons after confirmation of antibody titer / serum neutralizing antibody titer]

[0055] 2. Using ThermoGenesis Corp.'s closed multicomponent automated cell separation system, namely Multicomponent Automated Cell Separation System (MACSS), insert the plastic needle of the disposable separation cup into the sterile interface on the blood collection bag, and insert the blood collection bag Hang it up so that 60ml of blood naturally flows into the central compartment in the separation cup; 0.6ml of separation aid is pre-add...

Embodiment 2

[0066] Embodiment 2, the separation process of preparing component I+II+III and component II and component I+III from raw plasma,

[0067] 1. Preparation of buffer solution:

[0068] ①Ph4.75 0.15mol / L phosphate buffer: Na required per 1kg 2 HPO 4 12H 2 O is 53g, glacial acetic acid 27mL adjusts pH to 4.75, and the buffer solution that obtains is called Buffer A for short;

[0069] ②Ph5.25 0.5mol / L phosphate buffer: Na required per 1kg 2 HPO 4 12H 2 O is 160.6g, 24mL of glacial acetic acid adjusts pH to 5.25, and the damping fluid that obtains is called for short Buffer B;

[0070] ③ Component I+III balance liquid for pressure filtration: 0.13kg of 95% ethanol, Na 2 HPO 4 12H 2 O is 1.9g, 0.39mL of glacial acetic acid;

[0071] ④1mol / L sodium chloride solution: 58.5g of NaCl is required for every 1kg, add water to 1kg;

[0072] ⑤1mol / L sodium bicarbonate solution: 84.0g of NaCl is required for every 1kg, add water to 1kg;

[0073] ⑥1mol / L HCL solution: make 10.0L ...

Embodiment 3

[0085] Example 3, Precipitation and Dissolution of Component II and Purification of Immunoglobulin G by Column Chromatography

[0086] 1. Preparation of buffer solution:

[0087] ① Chromatographic equilibrium solution: add Na per 1kg 2 HPO 4 12H 2 O 3g, glacial acetic acid 0.27mL, add low-temperature water for injection to dissolve and adjust pH to 6.6-7.0, conductivity 1.3-1.5ms / cm, temperature 0-0.5°C;

[0088] ②Ph4.0 phosphate buffer: add Na per 1kg 2 HPO 4 12H 2 O 17.9g, NaCl 29.2g, glacial acetic acid about 1.5mL, dissolved in low-temperature water for injection;

[0089] ③pH4.0 acetic acid eluent: add NaAc·3H per 1kg 2 O 20.7g, NaCl 58.5g, glacial acetic acid 20.5mL, add water for injection to adjust pH=4.0;

[0090] 2. Dissolve and dilute the component II precipitate obtained in Example 2 with 10 times water for injection, the dissolution temperature is 0-4°C, and the dissolution time is ≥2h. After dissolution, adjust the pH to 6.6-7.0, conductivity 1.4ms, and...

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Abstract

The invention relates to a method for rapidly extracting plasma of a COVED-19 patient in a rehabilitation period by an automatic separation system. The method comprises the following steps of: separating peripheral blood taken from a human body into three component layers, namely an erythrocyte layer, a cell concentration layer and a plasma layer, by using a closed multi-cell component automatic separation system, performing virus inactivation on the obtained plasma, and optionally cryopreserving the plasma to obtain the plasma which can be used for preparing intravenous immunoglobulin G. Theinvention also comprises a method for preparing an intravenous immunoglobulin G preparation. The method comprises the following steps: obtaining a plasma component by the method, precipitating the plasma by a low-temperature ethanol method to obtain components I + II + III, separating a component II from a component I + III, respectively preparing an immunoglobulin G semi-finished product 1 and animmunoglobulin G semi-finished product 2, performing sterilization and virus inactivation to obtain an immunoglobulin G stock solution. and further preparing the intravenous immunoglobulin G preparation for intravenous injection. The method provided by the invention achieves excellent technical effects as described in the specification.

Description

technical field [0001] The invention belongs to the field of medical biotechnology, and in particular relates to a method for rapidly separating plasma components from whole blood to prepare intravenous COVID-19 immunoglobulin. In particular, it relates to a method for rapidly extracting convalescent plasma from COVID-19 patients using a closed automated separation system for multicellular fractions. In particular, it involves the use of a closed multicomponent automated cell separation system, the Multicomponent Automated Cell Separation System (MACSS, ThermoGenesis Corp.), to rapidly separate component plasma from whole blood for preparation of intravenous COVID-19 immunoglobulin G, such as Used to prepare hyperimmune globulin for intravenous injection. The intravenous injection of COVID-19 immune globulin can be used for the treatment of patients infected with the novel coronavirus COVID-19. Background technique [0002] Coronavirus disease 2019 (Coronavirus Disease 201...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/10C07K16/06C07K1/36C07K1/34C07K1/30C07K1/16A61K9/08A61K47/02A61K39/42A61P31/14
CPCC07K16/10C07K16/065A61K9/0019A61K9/08A61K47/02A61K39/42A61P31/14C07K2317/76C07K2317/35
Inventor 魏卿肖海蓉刘庆喜
Owner 深圳博雅感知药业有限公司
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