CN104248643A - Preparation device and preparation method of universal virus inactivation blood plasma - Google Patents

Preparation device and preparation method of universal virus inactivation blood plasma Download PDF

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Publication number
CN104248643A
CN104248643A CN201410395221.3A CN201410395221A CN104248643A CN 104248643 A CN104248643 A CN 104248643A CN 201410395221 A CN201410395221 A CN 201410395221A CN 104248643 A CN104248643 A CN 104248643A
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universal
blood plasma
riboflavin
plasma
preparation
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CN201410395221.3A
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汪德清
朱立国
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Chinese PLA General Hospital
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Chinese PLA General Hospital
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Abstract

The invention discloses a preparation device and a preparation method of universal virus inactivation blood plasma, the preparation device comprises a blood plasma mixing pool, a riboflavin solution container, a riboflavin reaction pool, a virus inactivation instrument and a centrifuge; the blood plasma mixing pool and the riboflavin solution container are connected with the riboflavin reaction pool by pipelines, and the riboflavin reaction pool is in turn connected with the virus inactivation instrument and the centrifuge. The preparation device and the preparation method can realize the continuous preparation of blood plasma, enhance the preparation efficiency of the blood plasma, can unify protein content specifications, improve the infusion efficiency, can reduce the titer of anti A and anti B two antibodies in the blood plasma, and inactivate all kinds of pathogens in the blood plasma and improve the safety of the blood plasma; and lyophilized powdery universal virus inactivation blood plasma is convenient in storage and transportation.

Description

Preparation facilities of a kind of universal virus inactivated plasma and preparation method thereof
Technical field
The present invention relates to blood plasma preparing technical field, in particular to a kind of preparation facilities and preparation method thereof of universal virus inactivated plasma, this preparation facilities and preparation method utilize riboflavin photochemical method Viral inactivation techniques to realize the preparation of universal virus inactivated plasma or universal inactivation of virus frozen dry blood plasma.
Background technology
In field of medical technology, inactivation of virus, mainly according to physics or chemical means dissolved destruction virus fat peplos or destroy the copying and transcribing of nucleic acid, loses appeal and destructive power to make virus.At present, modal blood-plasma virus killing has physics and chemistry two class methods, and wherein chemical classes method has: S/D method, methylene blue method (MB method), psoralen method and riboflavin photochemical method.Except S/D method, its blood plasma handled by excess-three kind method is all unit blood plasma.
In prior art, S/D method is only only applicable to the preparation of pooled plasma, and the method is invalid to fraction virus wherein, therefore cannot ensure all inactivation of virus, cause still likely there is virus in the blood plasma adopting S/D method to prepare, it is lower in the safety of medical field.
In prior art, although MB method is applied comparatively wide at home, the method is only only applicable to the inactivation of virus of single pocket type, and the loss of proteins of the method in viral inactivation steps is higher, has side effect, cannot meet the needs of medical field practical application.
The principle of the virus in riboflavin photochemical method deactivation blood plasma is: riboflavin is because of architectural characteristic, can embed in the nucleic acid of virus, under ultraviolet radiation, excite the transfer of its electronics, guanine residue on oxidation nucleic acid, the nucleic acid of virus is impaired by modifying, and can not carry out copying and repairing again, thus reach the effect of inactivation of viruses.
In prior art, based on riboflavin photochemical method, viral inactivation treatment is carried out to blood plasma, usual employing unit becomes the mode of bag to process blood plasma, pending blood plasma to be transferred in special illumination bag before treatment, in special environment, add riboflavin and be mixed evenly, pave to certain thickness, be placed in viral inactivation treatment equipment and carry out viral inactivation treatment, the blood plasma after viral inactivation treatment also will be shifted out and could use from illumination bag.The shortcoming of this kind of method is: complex operation, the continous way preparation of polynary blood plasma cannot be realized, lower to the efficiency of blood-plasma virus killing process, in medical practice, when needing the blood plasma after providing large batch of viral inactivation treatment, or when needing the autologous plasma of patient to feed back after inactivation of virus to patient, said method cannot meet the demand of practical application.
In sum, the blood plasma preparation facilities of prior art and preparation method cannot realize the continous way preparation of polynary blood plasma, and preparation efficiency is lower, can not meet the demand of medical field practical application.
Summary of the invention
An object of the present invention is the above-mentioned defect for prior art, provides a kind of preparation facilities of universal virus inactivated plasma.
Two of object of the present invention is the above-mentioned defects for prior art, provides a kind of preparation method of universal virus inactivated plasma.
The preparation facilities of universal virus inactivated plasma provided by the invention comprises blood plasma mixing pit, riboflavin solution container, riboflavin reaction tank, virus inactivation instrument and centrifuge;
Described blood plasma mixing pit is all connected with described riboflavin reaction tank by pipeline with described riboflavin solution container, and described riboflavin reaction tank is connected with described virus inactivation instrument and described centrifuge successively by pipeline.
Preferably, described preparation facilities also comprises the racking machine and freeze dryer that are connected successively by pipeline and described centrifuge.
Preferably, the bottom of described blood plasma mixing pit is provided with the first agitator; The bottom of riboflavin reaction tank is provided with the second agitator.
The preparation facilities described in preparation method employing of universal virus inactivated plasma provided by the invention, this preparation method comprises the steps:
A type, Type B and AB type three kinds of blood plasma Homogeneous phase mixing in blood plasma mixing pit is obtained liquid universal blood plasma, and this universal blood plasma flows to riboflavin reaction tank by blood plasma mixing pit;
Being added to by riboflavin solution in riboflavin solution container flows in the universal blood plasma of riboflavin reaction tank, and the universal blood plasma after interpolation riboflavin solution flows in riboflavin reaction tank, embeds in the nucleic acid of the pathogen in universal blood plasma at riboflavin reaction tank Riboflavin as photosensitizer;
Utilize virus inactivation instrument to carry out viral inactivation treatment by the mode of ultraviolet radiation to universal blood plasma and obtain universal virus inactivated plasma, and this universal virus inactivated plasma flows in centrifuge;
Utilize centrifuge to carry out centrifugal treating to the universal virus inactivated plasma obtained after viral inactivation treatment, to remove the antigenantibody complex in pooled plasma, obtain liquid universal virus inactivated plasma finished product.
Preferably, described preparation method also comprises the steps:
Utilize racking machine that the universal virus inactivated plasma finished product of the liquid state obtained after centrifugal treating is carried out subpackage;
Utilize the universal virus inactivated plasma finished product of freeze dryer to the liquid state after subpackage to carry out frozen dried, obtain pulverous universal inactivation of virus frozen dry blood plasma finished product.
Preferably, the volume ratio of A type, Type B and AB type blood plasma mixing is 6.5:2.5:1.
Preferably, temperature during the three kinds of blood plasma mixing of A type, Type B and AB type is 22 DEG C.
Preferably, utilize the first agitator bottom blood plasma mixing pit to make the three kinds of plasma uniform mixing of A type, Type B and AB type by the mode stirred, and the time be uniformly mixed is 1 hour.
Preferably, utilize the second agitator bottom riboflavin reaction tank to make riboflavin and universal blood plasma Homogeneous phase mixing by the mode stirred, and the time of stirring is 10min; After riboflavin and universal blood plasma Homogeneous phase mixing, the concentration of riboflavin reaction tank Riboflavin is 60 μm of ol/L.
Preferably, during viral inactivation treatment, adopt UVA ultraviolet and UVB ultraviolet to irradiate universal blood plasma, the intensity of illumination of ultraviolet radiation is 6mW/cm simultaneously 2, and the time of ultraviolet radiation be 10min.
The present invention has following beneficial effect:
Compare with preparation method with the blood plasma preparation facilities of prior art, described preparation facilities of the present invention and preparation method can realize the continous way preparation of blood plasma, improve the preparation efficiency of blood plasma; Protein content specification can be unified, improve engraftment efficiency; Tiring and all kinds of pathogen in deactivation blood plasma of anti-A and anti-B two kinds of antibody in blood plasma can be reduced, improve the safety of blood plasma; Pulverous universal inactivation of virus frozen dry blood plasma after frozen dried is convenient to store and transport.
Accompanying drawing explanation
The schematic diagram of the preparation facilities of the universal virus inactivated plasma that Fig. 1 provides for the embodiment of the present invention.
Detailed description of the invention
Below in conjunction with drawings and Examples, summary of the invention of the present invention is further described.
As shown in Figure 1, the preparation facilities of universal virus inactivated plasma that the present embodiment provides comprises blood plasma mixing pit 1, riboflavin solution container 2, riboflavin reaction tank 3, virus inactivation instrument 4 and centrifuge 5.Blood plasma mixing pit 1 is all connected with riboflavin reaction tank 3 by pipeline with riboflavin solution container 2, and riboflavin reaction tank 3 is connected with virus inactivation instrument 4 and centrifuge 5 successively by pipeline.Preferably, the bottom of blood plasma mixing pit 1 is provided with the first agitator (not shown), and the bottom of riboflavin reaction tank 3 is provided with the second agitator (not shown).
In a kind of preferred implementation of the present embodiment, described preparation facilities also comprises the racking machine 6 and freeze dryer 7 that are connected successively by pipeline and centrifuge 5.
Blood plasma mixing pit 1 is for being mixed to get liquid universal blood plasma for A type, Type B and AB type three kinds of plasma uniforms.Riboflavin solution container 2 is for holding riboflavin solution.Riboflavin reaction tank 3 is for embedding in the nucleic acid of the pathogen in pooled plasma as photosensitizer for riboflavin.Virus inactivation instrument 4 obtains universal virus inactivated plasma for carrying out viral inactivation treatment by the mode of ultraviolet radiation to pooled plasma.Centrifuge 5, for carrying out centrifugal treating to the universal virus inactivated plasma obtained after viral inactivation treatment, to remove the antigenantibody complex in pooled plasma, obtains liquid universal virus inactivated plasma finished product.Racking machine 6 carries out subpackage for the universal virus inactivated plasma finished product of the liquid state will obtained after centrifugal treating.Freeze dryer 7 is for carrying out frozen dried to the universal virus inactivated plasma finished product of the liquid state after subpackage.The mode be used for by stirring of the first agitator bottom blood plasma mixing pit 1 makes the three kinds of plasma uniform mixing of A type, Type B and AB type.The mode that the second agitator bottom riboflavin reaction tank 3 is used for by stirring makes riboflavin and universal blood plasma Homogeneous phase mixing.
The preparation method of the universal virus inactivated plasma that the present embodiment provides adopts above-mentioned preparation facilities, and this preparation method comprises the steps:
S1: A type, Type B and AB type three kinds of blood plasma Homogeneous phase mixing in blood plasma mixing pit 1 is obtained liquid universal blood plasma, and this universal blood plasma flows to riboflavin reaction tank 3 by blood plasma mixing pit 1; Preferably, the volume ratio of A type, Type B and AB type blood plasma mixing is 6.5:2.5:1; Temperature during the three kinds of blood plasma mixing of A type, Type B and AB type is 22 DEG C; Utilize the first agitator bottom blood plasma mixing pit 1 to make the three kinds of plasma uniform mixing of A type, Type B and AB type by the mode stirred, and the time be uniformly mixed is 1 hour;
S2: the riboflavin solution in riboflavin solution container 2 is added to and flows in the universal blood plasma of riboflavin reaction tank 3, and the universal blood plasma after interpolation riboflavin solution flows in riboflavin reaction tank 3, embeds in the nucleic acid of the pathogen in universal blood plasma at riboflavin reaction tank 3 Riboflavin as photosensitizer; Preferably, utilize the second agitator bottom riboflavin reaction tank 3 to make riboflavin and universal blood plasma Homogeneous phase mixing by the mode stirred, and the time of stirring is 10min; After riboflavin and universal blood plasma Homogeneous phase mixing, the concentration of riboflavin reaction tank 3 Riboflavin is 60 μm of ol/L;
S3: utilize virus inactivation instrument 4 to carry out viral inactivation treatment by the mode of ultraviolet radiation to universal blood plasma and obtain universal virus inactivated plasma, and this universal virus inactivated plasma flows in centrifuge 5; Preferably, during viral inactivation treatment, adopt UVA ultraviolet and UVB ultraviolet to irradiate universal blood plasma, the intensity of illumination of ultraviolet radiation is 6mW/cm simultaneously 2, and the time of ultraviolet radiation be 10min (i.e. the illumination dose of 3.6J);
S4: the universal virus inactivated plasma obtained after utilizing centrifuge 5 pairs of viral inactivation treatment carries out centrifugal treating, to remove the antigenantibody complex in pooled plasma, obtains liquid universal virus inactivated plasma finished product.
Preferably, described preparation method also comprises the steps:
S5: utilize racking machine 6 that the universal virus inactivated plasma finished product of the liquid state obtained after centrifugal treating is carried out subpackage; Such as, the universal virus inactivated plasma finished product of the liquid state obtained after centrifugal treating is packed or bottling;
S6: utilize the universal virus inactivated plasma finished product of the liquid state after freeze dryer 7 pairs of subpackages to carry out frozen dried, obtains pulverous universal inactivation of virus frozen dry blood plasma finished product.
It should be noted that, pipeline is provided with multiple controlled valve, is convenient to the preparation process controlling universal virus inactivated plasma in real time.
Compare with preparation method with the blood plasma preparation facilities of prior art, the described preparation facilities of the present embodiment and preparation method can realize the continous way preparation of blood plasma, improve the preparation efficiency of blood plasma; Protein content specification can be unified, improve engraftment efficiency; Tiring and all kinds of pathogen in deactivation blood plasma of anti-A and anti-B two kinds of antibody in blood plasma can be reduced, improve the safety of blood plasma; Pulverous universal inactivation of virus frozen dry blood plasma after frozen dried is convenient to store and transport.
Should be appreciated that above is illustrative and not restrictive by preferred embodiment to the detailed description that technical scheme of the present invention is carried out.Those of ordinary skill in the art can modify to the technical scheme described in each embodiment on the basis of reading description of the present invention, or carries out equivalent replacement to wherein portion of techniques feature; And these amendments or replacement, do not make the essence of appropriate technical solution depart from the spirit and scope of various embodiments of the present invention technical scheme.

Claims (10)

1. a preparation facilities for universal virus inactivated plasma, is characterized in that, this preparation facilities comprises blood plasma mixing pit, riboflavin solution container, riboflavin reaction tank, virus inactivation instrument and centrifuge;
Described blood plasma mixing pit is all connected with described riboflavin reaction tank by pipeline with described riboflavin solution container, and described riboflavin reaction tank is connected with described virus inactivation instrument and described centrifuge successively by pipeline.
2. the preparation facilities of universal virus inactivated plasma according to claim 1, is characterized in that, described preparation facilities also comprises the racking machine and freeze dryer that are connected successively by pipeline and described centrifuge.
3. the preparation facilities of universal virus inactivated plasma according to claim 1 and 2, is characterized in that, the bottom of described blood plasma mixing pit is provided with the first agitator; The bottom of riboflavin reaction tank is provided with the second agitator.
4. a preparation method for universal virus inactivated plasma, this preparation method adopts the preparation facilities according to any one of claim 1-3, and it is characterized in that, this preparation method comprises the steps:
A type, Type B and AB type three kinds of blood plasma Homogeneous phase mixing in blood plasma mixing pit is obtained liquid universal blood plasma, and this universal blood plasma flows to riboflavin reaction tank by blood plasma mixing pit;
Being added to by riboflavin solution in riboflavin solution container flows in the universal blood plasma of riboflavin reaction tank, and the universal blood plasma after interpolation riboflavin solution flows in riboflavin reaction tank, embeds in the nucleic acid of the pathogen in universal blood plasma at riboflavin reaction tank Riboflavin as photosensitizer;
Utilize virus inactivation instrument to carry out viral inactivation treatment by the mode of ultraviolet radiation to universal blood plasma and obtain universal virus inactivated plasma, and this universal virus inactivated plasma flows in centrifuge;
Utilize centrifuge to carry out centrifugal treating to the universal virus inactivated plasma obtained after viral inactivation treatment, to remove the antigenantibody complex in pooled plasma, obtain liquid universal virus inactivated plasma finished product.
5. the preparation method of universal virus inactivated plasma according to claim 4, is characterized in that, described preparation method also comprises the steps:
Utilize racking machine that the universal virus inactivated plasma finished product of the liquid state obtained after centrifugal treating is carried out subpackage;
Utilize the universal virus inactivated plasma finished product of freeze dryer to the liquid state after subpackage to carry out frozen dried, obtain pulverous universal inactivation of virus frozen dry blood plasma finished product.
6. the preparation method of the universal virus inactivated plasma according to claim 4 or 5, is characterized in that, the volume ratio of A type, Type B and AB type blood plasma mixing is 6.5:2.5:1.
7. the preparation method of the universal virus inactivated plasma according to claim 4 or 5, is characterized in that, temperature during the three kinds of blood plasma mixing of A type, Type B and AB type is 22 DEG C.
8. the preparation method of the universal virus inactivated plasma according to claim 4 or 5, it is characterized in that, utilize the first agitator bottom blood plasma mixing pit to make the three kinds of plasma uniform mixing of A type, Type B and AB type by the mode stirred, and the time be uniformly mixed is 1 hour.
9. the preparation method of the universal virus inactivated plasma according to claim 4 or 5, it is characterized in that, utilize the second agitator bottom riboflavin reaction tank to make riboflavin and universal blood plasma Homogeneous phase mixing by the mode stirred, and the time of stirring is 10min; After riboflavin and universal blood plasma Homogeneous phase mixing, the concentration of riboflavin reaction tank Riboflavin is 60 μm of ol/L.
10. the preparation method of the universal virus inactivated plasma according to claim 4 or 5, is characterized in that, during viral inactivation treatment, adopt UVA ultraviolet and UVB ultraviolet to irradiate universal blood plasma, the intensity of illumination of ultraviolet radiation is 6mW/cm simultaneously 2, and the time of ultraviolet radiation be 10min.
CN201410395221.3A 2014-08-12 2014-08-12 Preparation device and preparation method of universal virus inactivation blood plasma Pending CN104248643A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106492245A (en) * 2016-12-23 2017-03-15 中国人民解放军***南京总医院 Bloodborne pathogens inactivating device
CN107496950A (en) * 2017-08-18 2017-12-22 广州市众为生物技术有限公司 A kind of viral method in UV irradiation inactivation protein solution
CN109966574A (en) * 2016-02-02 2019-07-05 汪相伯 A kind for the treatment of of blood products system based on riboflavin photochemical method

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109966574A (en) * 2016-02-02 2019-07-05 汪相伯 A kind for the treatment of of blood products system based on riboflavin photochemical method
CN106492245A (en) * 2016-12-23 2017-03-15 中国人民解放军***南京总医院 Bloodborne pathogens inactivating device
CN107496950A (en) * 2017-08-18 2017-12-22 广州市众为生物技术有限公司 A kind of viral method in UV irradiation inactivation protein solution
CN107496950B (en) * 2017-08-18 2021-02-02 广州市众为生物技术有限公司 Method for inactivating virus in protein solution by ultraviolet irradiation

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Application publication date: 20141231