CN105481939A - Device for treating cryoprecipitate and method for preparing cryoprecipitate - Google Patents
Device for treating cryoprecipitate and method for preparing cryoprecipitate Download PDFInfo
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- CN105481939A CN105481939A CN201511004902.3A CN201511004902A CN105481939A CN 105481939 A CN105481939 A CN 105481939A CN 201511004902 A CN201511004902 A CN 201511004902A CN 105481939 A CN105481939 A CN 105481939A
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- cryoprecipitate
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
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Abstract
The invention relates to a device for treating cryoprecipitate and a method for preparing cryoprecipitate. Particularly, the device comprises a tray, a mesh knife and a cover plate, wherein a cryoprecipitate containing space is defined in the tray; the mesh knife is matched with the tray, and is suitable to be inserted into the cryoprecipitate containing space; and the cover plate is matched with the tray, and is suitable for sealing the cryoprecipitate containing space. The cryoprecipitate prepared by using the device has the advantages of high uniformity and high quality; and the device ensures the activity of the coagulation factor VIII in the cryoprecipitate.
Description
Technical field
The present invention relates to blood products production technique, be specifically related to a kind of device for the treatment of cryoprecipitate and prepare method and the application thereof of cryoprecipitate.
Background technology
Cryoprecipitate is fresh frozen plasma undissolved white depositions under 1 DEG C of-4 DEG C of condition, wherein mainly contains: the multiple components such as Fibrinogen, platelet cofactor Ⅰ, von Wilebrand factor (vWF), coagulation factor XⅢ, Fiberonectin (Fn).As the raw material of producd fibers proteinogen and platelet cofactor Ⅰ, in cryoprecipitate, the content of Fibrinogen and platelet cofactor Ⅰ and activity directly affect quality and the yield of product.Wherein, platelet cofactor Ⅰ is extremely unstable, by various factors and with to be separated preparation process closely related.
In traditional cold precipitation production process, as patent 201410258903.X " a kind of method and application thereof preparing cryoprecipitate ", blood plasma obtains after cryoprecipitate through centrifugation, use the instrument such as cutter, shovel to cut frustillatum bit by bit, be placed in the container such as disposable PET bottle or sanitation-grade plastics bag and carry out quick-frozen.Use this ordinary method process cryoprecipitate, the acetaldehyde that its releasing agent and decomposition produce can bring harm to cryoprecipitate and pollute; Each collection and shearing need spend the more time, and precipitation open-assembly time is longer; Plastic material poor heat conductivity, freezes slowly, to cause wherein platelet cofactor Ⅰ to be tired and significantly decay; Human users, utensil in shear history, the situation such as easily cause bacterial endotoxin index defective.
For this reason, urgently improve for the treatment of the device of cryoprecipitate and the method for preparing cryoprecipitate.
Summary of the invention
The present invention is intended to solve one of technical problem in correlation technique at least to a certain extent.
According to a first aspect of the invention, the present invention proposes a kind of device for the treatment of cryoprecipitate, comprising: pallet, limits cryoprecipitate spatial accommodation in described pallet; Net cutter, described net cutter mates with described pallet, is suitable for inserting in described cryoprecipitate spatial accommodation; Cover plate, described cover plate mates with described pallet, is suitable for closed described cryoprecipitate spatial accommodation.Described device has following advantage: (1) is easy to cleaning, sterilization; (2) disposable precipitation can be cut into multi-disc, avoid precipitating long-time exposure, time saving and energy saving; (3) avoid using PET bottle or a grade plastics bag of making a living, save cost; (4) the cryoprecipitate size using this device to prepare is homogeneous, quality is high, effectively ensure that the activity of platelet cofactor Ⅰ in cryoprecipitate; (5) avoid releasing agent and decompose the harm and pollution that the acetaldehyde that produces brings cryoprecipitate.
According to some embodiments of the present invention, described net cutter is arranged on the lower surface of described cover plate, optionally, described cover plate upper surface is provided with handle, can vertically net cutter be inserted in pallet by described cover plate, make that net cutter is disposable to be cut thing to be cut, obtain uniform section, and can not extrude, damage thing to be cut.
According to some embodiments of the present invention, the described device for the treatment of cryoprecipitate, comprises: web member further, described web member is connected with pallet with cover plate respectively, buckling piece, and described buckling piece is connected with pallet with cover plate respectively, preferably, described web member is hinge.
According to some embodiments of the present invention, described buckling piece is pressure latch mechanism, and preferably, described pressure latch mechanism comprises: constrictor, and described constrictor is arranged on the sidewall of described pallet; Fixed orifices, described fixed orifices is arranged on described cover sidewall internal surface, and described fixed orifices mates with described compression piece; Optionally, described pressure latch mechanism comprises further: constrictor control piece, and described constrictor control piece is connected with described constrictor.
According to some embodiments of the present invention, described net cutter is made up of multiple blade, and the multiple grid of described multiple blade formation arranged in a crossed manner, optionally, described multiple grid separately forms square, Polygons or circle; Optionally, described multiple grid separately has the area of 1-6.25 square centimeter; Optionally, described blade comprises horizontal blade and longitudinal blade, described horizontal blade and described longitudinal blade arranged in a crossed manner; Optionally, in described horizontal blade and described longitudinal blade intersection arranged in a crossed manner, described horizontal blade and described longitudinal blade one of are at least formed with otch.Utilize described net cutter disposable thing to be cut can be cut into multi-disc, and obtain uniform section.
According to some embodiments of the present invention, the described device for the treatment of cryoprecipitate, comprises: guide further, and described guide is arranged on the internal surface of described pallet side wall, and the mesh fitting of described guide and described net cutter pre-position.By described guide, net cutter is vertically inserted in pallet, such that net cutter is disposable to be cut thing to be cut, obtain uniform section, and can not extrude, damage thing to be cut.
According to some embodiments of the present invention, described pallet, described net cutter and described cover plate are separately made up of stainless steel, and preferably, described stainless steel is 316 stainless steels.Stainless steel hot conduction efficiency is high, and its precipitation freezing rate is far away higher than the freezing rate of PET bottle or sanitation-grade plastics bag.
According to a second aspect of the invention, the present invention proposes a kind of method preparing cryoprecipitate, comprises the following steps: (1) pre-treatment: after being melted in advance by freezing blood plasma, stir, and keep the blood plasma temperature 0-8 degree Celsius after melting in advance, to obtain pretreated blood plasma; (2) collecting precipitation: by pretreated blood plasma feed liquor speed be 1-2.5L/ platform/point under carry out centrifugal so that obtain precipitation; (3) cutting precipitation: adopt described in the above-mentioned device process for the treatment of cryoprecipitate and precipitate, to obtain the precipitation after cutting; (4) freeze forming: the device containing the precipitation after described cutting is positioned over less than-70 DEG C and carries out freeze forming, to obtain cryoprecipitate.Described method has following advantage: (1) obviously shortens the time of preparation cryoprecipitate compared with ordinary method; (2) avoid using PET bottle or a grade plastics bag of making a living, save cost; (3) the cryoprecipitate size utilizing the method to prepare is homogeneous, quality is high, effectively ensure that the activity of platelet cofactor Ⅰ in cryoprecipitate; (4) avoid releasing agent and decompose the harm and pollution that the acetaldehyde that produces brings cryoprecipitate.
According to some embodiments of the present invention, described step (3) comprises further: (3-1) described precipitation is cut off be laid in above-mentioned for the treatment of in the described pallet in the device of cryoprecipitate; (3-2) to be above-mentionedly positioned over fast on pallet for the treatment of the net cutter in the device of cryoprecipitate, described cover plate to be fastened simultaneously.
According to a third aspect of the invention we, the present invention proposes a kind of method preparing cryoprecipitate, comprise the following steps: (1) pre-treatment: after freezing blood plasma is melted 12-26 hour in advance at-5-5 DEG C, stir, and keep the blood plasma temperature 0-8 DEG C after melting in advance, to obtain pretreated blood plasma; (2) collecting precipitation: feed liquor speed be 1-3.5L/ platform/point, going out liquid temp is, at 0-8 DEG C, pretreated blood plasma is carried out centrifugal 5-15 minute, so as to obtain precipitation; (3) cutting precipitation: adopt described in claim 1-8 for the treatment of cryoprecipitate device process described in precipitate, to obtain the precipitation after cutting; (4) freeze forming: the device containing the precipitation after described cutting is positioned over less than-70 DEG C and carries out freeze forming, to obtain cryoprecipitate.Described method has following advantage: (1) obviously shortens the time of preparation cryoprecipitate compared with ordinary method; (2) avoid using PET bottle or a grade plastics bag of making a living, save cost; (3) the cryoprecipitate size utilizing the method to prepare is homogeneous, quality is high, effectively ensure that the activity of platelet cofactor Ⅰ in cryoprecipitate; (4) avoid releasing agent and decompose the harm and pollution that the acetaldehyde that produces brings cryoprecipitate.
According to some embodiments of the present invention, described step (3) comprises further: (3-1) described precipitation is cut off be laid in above-mentioned for the treatment of in the described pallet in the device of cryoprecipitate; (3-2) be positioned over above-mentioned fast on pallet for the treatment of the net cutter in the device of cryoprecipitate, described cover plate fastened simultaneously.
Accompanying drawing explanation
Fig. 1 is the Longitudinal cross section schematic of the device for the treatment of cryoprecipitate according to an embodiment of the invention;
Fig. 2 is the cross sectional representation of the device for the treatment of cryoprecipitate according to an embodiment of the invention;
Fig. 3 (A) is according to an embodiment of the invention for the treatment of the net knife structure schematic diagram in the device of cryoprecipitate;
Fig. 3 (B) is according to an embodiment of the invention for the treatment of the cover plate in the device of cryoprecipitate and support holder structure schematic diagram;
Fig. 4 is the cross sectional representation of the device for the treatment of cryoprecipitate according to an embodiment of the invention;
Fig. 5 is according to an embodiment of the invention for the treatment of the net knife structure schematic diagram in the device of cryoprecipitate;
Fig. 6 is the cross sectional representation of the device for the treatment of cryoprecipitate according to an embodiment of the invention;
Fig. 7 is the structural representation of the device for the treatment of cryoprecipitate according to an embodiment of the invention;
Fig. 8 is the Longitudinal cross section schematic of the device for the treatment of cryoprecipitate according to an embodiment of the invention;
Fig. 9 is the cross sectional representation of the device for the treatment of cryoprecipitate according to an embodiment of the invention;
Figure 10 is according to an embodiment of the invention for the treatment of the cover plate in the device of cryoprecipitate and net knife structure schematic diagram;
Figure 11 is the structural representation for the treatment of pallet in the device of cryoprecipitate according to an embodiment of the invention.
Reference numeral:
100: cover plate, 200: pallet, 300: web member, 400: buckling piece, 500: guide, 600: net cutter, 700: handle
Embodiment
Be described below in detail embodiments of the invention, the example of described embodiment is shown in the drawings, and wherein same or similar label represents same or similar element or has element that is identical or similar functions from start to finish.Be exemplary below by the embodiment be described with reference to the drawings, be intended to for explaining the present invention, and can not limitation of the present invention be interpreted as.
Describe according to an embodiment of the invention for the treatment of the device of cryoprecipitate referring to Fig. 1-Fig. 3 (B).
Device for the treatment of cryoprecipitate according to an embodiment of the invention, comprises cover plate 100, pallet 200 and net cutter 600, wherein, limits cryoprecipitate spatial accommodation in pallet 200; Net cutter 600 mates with pallet 200, is suitable for inserting in described cryoprecipitate spatial accommodation; Cover plate 100 mates with pallet 200, is suitable for closed described cryoprecipitate spatial accommodation.According to a particular embodiment of the invention, the shape of pallet 200 can be long for 40-60cm, wide be 40-60cm, the high rectangular parallelepiped for 4-8cm.
According to a particular embodiment of the invention, the above-mentioned device for the treatment of cryoprecipitate comprises further: web member 300 and buckling piece 400, wherein, web member 300 is connected with pallet 200 with cover plate 100 respectively, can be connected with pallet 200 side with cover plate 100 respectively particularly, and then cover plate 100 can be made can be connected by open-close type with pallet 200.In addition, buckling piece 400 is connected with pallet 200 with cover plate 100 respectively, and then when cover plate 100 is fastened on the opening end of pallet 200, the two to be pinned and close by buckling piece 400.According to a particular embodiment of the invention, web member 300 can be preferably hinge.According to a particular embodiment of the invention, buckling piece 400 preferably can press latch mechanism, and pressure latch mechanism comprises constrictor, and constrictor is arranged on the sidewall of described pallet; Fixed orifices, fixed orifices is arranged on described cover sidewall internal surface, and fixed orifices mates with described compression piece.According to a particular embodiment of the invention, latch mechanism is pressed to comprise further: constrictor control piece, described constrictor control piece is connected with described constrictor.
According to a particular embodiment of the invention, the above-mentioned device for the treatment of cryoprecipitate comprises guide 500 further, and guide 500 is arranged on the internal surface of pallet 200 sidewall, the mesh fitting of guide 500 and net cutter 600 pre-position.
Pallet 200, net cutter 600 are separately made up of stainless steel with cover plate 100 according to a particular embodiment of the invention, and preferably, described stainless steel is 316 stainless steels.
According to a particular embodiment of the invention, net cutter is made up of multiple blade, and the multiple grid of described multiple blade formation arranged in a crossed manner, grid separately forms hexagon, and the area of grid is separately 1-6.25 square centimeter.
Conveniently understand, the use-pattern of the above-mentioned device for the treatment of cryoprecipitate is provided, specific as follows: first, by the above-mentioned precipitation prepared step (1) in the method for cryoprecipitate and (2) and obtain.Secondly, precipitation is cut off and is laid in pallet 200, net cutter 600 is entered in pallet 200 according to the guiding of guide 500, disposable cutting is carried out to described precipitation, guarantee slice size is homogeneous, after making cover plate 100 and pallet 200 be in fixed closed state by buckling piece 400, the described device for the treatment of cryoprecipitate is positioned over-70 DEG C, thus obtains cryoprecipitate.
Describe according to an embodiment of the invention for the treatment of the device of cryoprecipitate referring to Fig. 4-Fig. 5.
Device for the treatment of cryoprecipitate according to an embodiment of the invention, comprises cover plate 100, pallet 200 and net cutter 600, wherein, limits cryoprecipitate spatial accommodation in pallet 200; Net cutter 600 mates with pallet 200, is suitable for inserting in described cryoprecipitate spatial accommodation; Cover plate 100 mates with pallet 200, is suitable for closed described cryoprecipitate spatial accommodation.According to a particular embodiment of the invention, the shape of pallet 200 can be the rectangular parallelepiped of long 40-60cm, wide 40-60cm, high 4-8cm
According to a particular embodiment of the invention, the above-mentioned device for the treatment of cryoprecipitate comprises further: web member 300 and buckling piece 400, wherein, web member 300 is connected with pallet 200 with cover plate 100 respectively, can be connected with pallet 200 side with cover plate 100 respectively particularly, and then cover plate 100 can be made can be connected by open-close type with pallet 200.In addition, buckling piece 400 is connected with pallet 200 with cover plate 100 respectively, and then when cover plate 100 is fastened on the opening end of pallet 200, the two to be pinned and close by buckling piece 400.According to a particular embodiment of the invention, web member 300 can be preferably hinge.According to a particular embodiment of the invention, buckling piece 400 preferably can press latch mechanism, and pressure latch mechanism comprises constrictor, and constrictor is arranged on the sidewall of described pallet; Fixed orifices, fixed orifices is arranged on described cover sidewall internal surface, and fixed orifices mates with described compression piece.According to a particular embodiment of the invention, latch mechanism is pressed to comprise further: constrictor control piece, described constrictor control piece is connected with described constrictor.
According to a particular embodiment of the invention, the above-mentioned device for the treatment of cryoprecipitate comprises guide 500 further, and guide 500 is arranged on the internal surface of pallet 200 sidewall, the mesh fitting of guide 500 and net cutter 600 pre-position.
Pallet 200, net cutter 600 are separately made up of stainless steel with cover plate 100 according to a particular embodiment of the invention, and preferably, described stainless steel is 316 stainless steels.
According to a particular embodiment of the invention, net cutter is made up of multiple blade, and the multiple grid of described multiple blade formation arranged in a crossed manner, grid separately forms square, and grid separately has the area of 1-6.25 square centimeter.According to a particular embodiment of the invention, blade comprises horizontal blade and longitudinal blade, horizontal blade and longitudinal blade arranged in a crossed manner; In described horizontal blade and described longitudinal blade intersection arranged in a crossed manner, described horizontal blade and described longitudinal blade one of are at least formed with otch, such as horizontal blade has otch, longitudinal blade does not have otch, longitudinal blade by make through horizontal blade otch horizontal blade and longitudinal blade arranged in a crossed manner.Or horizontal blade does not have otch, longitudinal blade has otch, horizontal blade by make through longitudinal blade otch horizontal blade and longitudinal blade arranged in a crossed manner.Or horizontal blade has otch, longitudinal blade has otch, horizontal blade otch mate with longitudinal blade otch make horizontal blade and longitudinal blade arranged in a crossed manner.
Conveniently understand, the use-pattern of the above-mentioned device for the treatment of cryoprecipitate is provided, specific as follows: first, by the above-mentioned precipitation prepared step (1) in the method for cryoprecipitate and (2) and obtain.Secondly, precipitation is cut off and is laid in pallet 200, net cutter 600 is entered in pallet 200 according to the guiding of guide 500, disposable cutting is carried out to described precipitation, guarantee slice size is homogeneous, after making cover plate 100 and pallet 200 be in fixed closed state by buckling piece 400, the described device for the treatment of cryoprecipitate is positioned over-70 DEG C, thus obtains cryoprecipitate.
Describe according to an embodiment of the invention for the treatment of the device of cryoprecipitate referring to Fig. 6-Fig. 7.
Device for the treatment of cryoprecipitate according to an embodiment of the invention, comprises cover plate 100, pallet 200 and net cutter 600, wherein, limits cryoprecipitate spatial accommodation in pallet 200; Net cutter 600 mates with pallet 200, is suitable for inserting in described cryoprecipitate spatial accommodation; Cover plate 100 mates with pallet 200, is suitable for closed described cryoprecipitate spatial accommodation.According to a particular embodiment of the invention, the shape of pallet 200 can be the rectangular parallelepiped of long 40-60cm, wide 40-60cm, high 4-8cm.
According to a particular embodiment of the invention, net cutter 600 is arranged on the lower surface of cover plate 100, and net cutter 600 and cover plate 100 link together.
According to a particular embodiment of the invention, the above-mentioned device for the treatment of cryoprecipitate comprises further: web member 300 and buckling piece 400, wherein, web member 300 is connected with pallet 200 with cover plate 100 respectively, can be connected with pallet 200 side with cover plate 100 respectively particularly, and then cover plate 100 can be made can be connected by open-close type with pallet 200.In addition, buckling piece 400 is connected with pallet 200 with cover plate 100 respectively, and then when cover plate 100 is fastened on the opening end of pallet 200, the two to be pinned and close by buckling piece 400.According to a particular embodiment of the invention, web member 300 can be preferably hinge.According to a particular embodiment of the invention, buckling piece 400 preferably can press latch mechanism, and pressure latch mechanism comprises constrictor, and constrictor is arranged on the sidewall of described pallet; Fixed orifices, fixed orifices is arranged on described cover sidewall internal surface, and fixed orifices mates with described compression piece.According to a particular embodiment of the invention, latch mechanism is pressed to comprise further: constrictor control piece, described constrictor control piece is connected with described constrictor.
Pallet 200, net cutter 600 are separately made up of stainless steel with cover plate 100 according to a particular embodiment of the invention, and preferably, described stainless steel is 316 stainless steels.
According to a particular embodiment of the invention, net cutter is made up of multiple blade, and the multiple grid of described multiple blade formation arranged in a crossed manner, grid separately forms square, and grid separately has the area of 1-6.25 square centimeter.According to a particular embodiment of the invention, blade comprises horizontal blade and longitudinal blade, horizontal blade and longitudinal blade arranged in a crossed manner; In described horizontal blade and described longitudinal blade intersection arranged in a crossed manner, described horizontal blade and described longitudinal blade one of are at least formed with otch.Such as horizontal blade has otch, and longitudinal blade does not have otch, longitudinal blade by make through horizontal blade otch horizontal blade and longitudinal blade arranged in a crossed manner.Or horizontal blade does not have otch, longitudinal blade has otch, horizontal blade by make through longitudinal blade otch horizontal blade and longitudinal blade arranged in a crossed manner.Or horizontal blade has otch, longitudinal blade has otch, horizontal blade otch mate with longitudinal blade otch make horizontal blade and longitudinal blade arranged in a crossed manner.
Conveniently understand, the use-pattern of the above-mentioned device for the treatment of cryoprecipitate is provided, specific as follows: first, by the above-mentioned precipitation prepared step (1) in the method for cryoprecipitate and (2) and obtain.Secondly, precipitation is cut off and is laid in pallet 200, by rotating plate 100, net cutter 600 is inserted in pallet 200, disposable cutting is carried out to described precipitation, guarantee slice size is homogeneous, after making cover plate 100 and pallet 200 be in fixed closed state by buckling piece 400, the described device for the treatment of cryoprecipitate is positioned over-70 DEG C, thus obtains cryoprecipitate.
Describe according to an embodiment of the invention for the treatment of the device of cryoprecipitate referring to Fig. 8-Figure 11.
Device for the treatment of cryoprecipitate according to an embodiment of the invention, comprises cover plate 100, pallet 200 and net cutter 600, wherein, limits cryoprecipitate spatial accommodation in pallet 200; Net cutter 600 mates with pallet 200, is suitable for inserting in described cryoprecipitate spatial accommodation; Cover plate 100 mates with pallet 200, is suitable for closed described cryoprecipitate spatial accommodation.According to a particular embodiment of the invention, the shape of pallet 200 can be the rectangular parallelepiped of long 40-60cm, wide 40-60cm, high 4-8cm.
According to a particular embodiment of the invention, net cutter 600 is arranged on the lower surface of cover plate 100, and net cutter 600 and cover plate 100 link together.According to a particular embodiment of the invention, cover plate 100 upper surface is provided with handle 700.
According to a particular embodiment of the invention, the above-mentioned device for the treatment of cryoprecipitate comprises further: buckling piece 400, buckling piece 400 is connected with pallet 200 with cover plate 100 respectively, and then when cover plate 100 is fastened on the opening end of pallet 200, the two to be pinned and close by buckling piece 400.According to a particular embodiment of the invention, buckling piece 400 preferably can press latch mechanism, and pressure latch mechanism comprises constrictor, and constrictor is arranged on the sidewall of described pallet; Fixed orifices, fixed orifices is arranged on described cover sidewall internal surface, and fixed orifices mates with described compression piece.According to a particular embodiment of the invention, latch mechanism is pressed to comprise further: constrictor control piece, described constrictor control piece is connected with described constrictor.
Pallet 200, net cutter 600 are separately made up of stainless steel with cover plate 100 according to a particular embodiment of the invention, and preferably, described stainless steel is 316 stainless steels.
According to a particular embodiment of the invention, net cutter is made up of multiple blade, and the multiple grid of described multiple blade formation arranged in a crossed manner, grid separately forms square, and grid separately has the area of 1-6.25 square centimeter.According to a particular embodiment of the invention, blade comprises horizontal blade and longitudinal blade, horizontal blade and longitudinal blade arranged in a crossed manner; In described horizontal blade and described longitudinal blade intersection arranged in a crossed manner, described horizontal blade and described longitudinal blade one of are at least formed with otch.Such as horizontal blade has otch, and longitudinal blade does not have otch, longitudinal blade by make through horizontal blade otch horizontal blade and longitudinal blade arranged in a crossed manner.Or horizontal blade does not have otch, longitudinal blade has otch, horizontal blade by make through longitudinal blade otch horizontal blade and longitudinal blade arranged in a crossed manner.Or horizontal blade has otch, longitudinal blade has otch, horizontal blade otch mate with longitudinal blade otch make horizontal blade and longitudinal blade arranged in a crossed manner.
Conveniently understand, the use-pattern of the above-mentioned device for the treatment of cryoprecipitate is provided, specific as follows: first, by the above-mentioned precipitation prepared step (1) in the method for cryoprecipitate and (2) and obtain.Secondly, precipitation is cut off and is laid in pallet 200, directly net cutter 600 is inserted in pallet 200 by cover plate 100, disposable cutting is carried out to described precipitation, guarantee slice size is homogeneous, after making cover plate 100 and pallet 200 be in fixed closed state by buckling piece 400, the described device for the treatment of cryoprecipitate is positioned over-70 DEG C, thus obtains cryoprecipitate.
Embodiment
Embodiment 1:
1, plasma screening: screen the refrigerated plasma of outbound, picks out damaged blood plasma, and damaged blood plasma will be chosen in time.The blood plasma screened is put into-5-5 DEG C of blood plasma and is melted freezer in advance.
2, first purified water washing below 37 DEG C, then through 75% ethanol disinfection (soak 2 ~ 5 minutes and rock).Then this plasma bags is reaped on sink.Use less than the 37 DEG C abundant drip washing plasma bags surfaces of water for injection again.
3, on throwing slurry dish, pick up plasma bags side on the other hand, make it slightly toward having a down dip, plasma bags is cut off from edge, lower end by another hand-held scissors, collects blood plasma.The scissors collected will wash once with water for injection every 15 minutes.
4, collect 500L blood plasma altogether, centrifugation under 0-8 DEG C of condition (whizzer GQ142, Shanghai centrifugal machine institute), feed liquor speed is: 1-3.5L/ platform/point, go out liquid temp and control at 0-8 DEG C.
5, keep whizzer running 5-15 minute after stopping feed liquor, collect cryoprecipitate.Cryoprecipitate thickness is about 1cm, and No. 1 whizzer adopts treatment process of the present invention, takes out the cryoprecipitate in centrifugal reel, cuts off and be laid in storage trays, be then positioned over fast on pallet by cutting square, simultaneously fixed rotating shaft and buckle.Cutting square mesh is 1.0cm*1.0cm.No. 2 whizzers adopt ordinary method, use spader that cryoprecipitate is cut into bulk, are positioned in sanitation-grade plastics bag.
6, after pallet closing lid, be positioned in less than-70 DEG C refrigerators.
7, observe cryoprecipitate and freeze shaping required time, treatment process gained cryoprecipitate of the present invention due to heat conduction very fast, suitable size, freeze shaping, and ordinary method is just freezed shaping after 4.5 hours after 1.5 hours.
Embodiment 2
1, plasma screening: screen the refrigerated plasma of outbound, picks out damaged blood plasma, and damaged blood plasma will be chosen in time.The blood plasma screened is put into-5-5 DEG C of blood plasma and is melted freezer in advance.
2, first purified water washing below 37 DEG C, then through 75% ethanol disinfection (soak 2 ~ 5 minutes and rock).Then this plasma bags is reaped on sink.Use less than the 37 DEG C abundant drip washing plasma bags surfaces of water for injection again.
3, on throwing slurry dish, pick up plasma bags side on the other hand, make it slightly toward having a down dip, plasma bags is cut off from edge, lower end by another hand-held scissors, collects blood plasma.The scissors collected will wash once with water for injection every 15 minutes.
4, collect 800L blood plasma centrifugation under 0-8 DEG C of condition (whizzer GQ142, Shanghai centrifugal machine institute) altogether, feed liquor speed is: 1-3.5L/ platform/point, go out liquid temp and control at 0-8 DEG C.
5, keep whizzer running 5-15 minute after stopping feed liquor, collect cryoprecipitate.Cryoprecipitate thickness is about 1.8cm, and No. 1 whizzer adopts treatment process of the present invention, takes out the cryoprecipitate in centrifugal reel, cuts off and be laid in storage trays, be then positioned over fast on pallet by cutting square, simultaneously fixed rotating shaft and buckle.Cutting square mesh is 1.5cm*1.5cm.No. 2 whizzers adopt ordinary method, use spader that cryoprecipitate is cut into bulk, are positioned in sanitation-grade plastics bag.
6, after pallet closing lid, be positioned in less than-70 DEG C refrigerators.
7, observe cryoprecipitate and freeze shaping required time, treatment process gained cryoprecipitate of the present invention due to heat conduction very fast, suitable size, freeze shaping, and ordinary method is just freezed shaping after 5 hours after 2 hours.
Embodiment 3
1, plasma screening: screen the refrigerated plasma of outbound, picks out damaged blood plasma, and damaged blood plasma will be chosen in time.The blood plasma screened is put into-5-5 DEG C of blood plasma and is melted freezer in advance.
2, first purified water washing below 37 DEG C, then through 75% ethanol disinfection (soak 2 ~ 5 minutes and rock).Then this plasma bags is reaped on sink.Use less than the 37 DEG C abundant drip washing plasma bags surfaces of water for injection again.
3, on throwing slurry dish, pick up plasma bags side on the other hand, make it slightly toward having a down dip, plasma bags is cut off from edge, lower end by another hand-held scissors, collects blood plasma.The scissors collected will wash once with water for injection every 15 minutes.
4, collect 1100L blood plasma centrifugation under 0-8 DEG C of condition (whizzer GQ142, Shanghai centrifugal machine institute) altogether, feed liquor speed is: 1-3.5L/ platform/point, go out liquid temp and control at 0-8 DEG C.
5, keep whizzer running 5-15 minute after stopping feed liquor, collect cryoprecipitate.Cryoprecipitate thickness is about 2.5cm, and No. 1 whizzer adopts treatment process of the present invention, takes out the cryoprecipitate in centrifugal reel, cuts off and be laid in storage trays, be then positioned over fast on pallet by cutting square, simultaneously fixed rotating shaft and buckle.Cutting square mesh is 1.8cm*1.8cm.No. 2 whizzers adopt ordinary method, use spader that cryoprecipitate is cut into bulk, are positioned in sanitation-grade plastics bag.
6, after pallet closing lid, be positioned in less than-70 DEG C refrigerators.
7, observe cryoprecipitate and freeze shaping required time, treatment process gained cryoprecipitate of the present invention due to heat conduction very fast, suitable size, freeze shaping, and ordinary method is just freezed shaping after 6 hours after 2.5 hours.
Embodiment 4
1, plasma screening: screen the refrigerated plasma of outbound, picks out damaged blood plasma, and damaged blood plasma will be chosen in time.The blood plasma screened is put into-5-5 DEG C of blood plasma and is melted freezer in advance.
2, first purified water washing below 37 DEG C, then through 75% ethanol disinfection (soak 2 ~ 5 minutes and rock).Then this plasma bags is reaped on sink.Use less than the 37 DEG C abundant drip washing plasma bags surfaces of water for injection again.
3, on throwing slurry dish, pick up plasma bags side on the other hand, make it slightly toward having a down dip, plasma bags is cut off from edge, lower end by another hand-held scissors, collects blood plasma.The scissors collected will wash once with water for injection every 15 minutes.
4, collect blood plasma 4000L altogether, centrifugation under 0-8 DEG C of condition (whizzer GQ142, Shanghai centrifugal machine institute), feed liquor speed is: 1-3.5L/ platform/point, go out liquid temp and control at 0-8 DEG C.
5, keep whizzer running 5-15 minute after stopping feed liquor, collect cryoprecipitate.No. 1 whizzer adopts treatment process of the present invention, takes out the cryoprecipitate in centrifugal reel, cuts off and be laid in storage trays, be then positioned over fast on pallet by cutting square, simultaneously fixed rotating shaft and buckle.No. 2 whizzers adopt ordinary method, use spader that cryoprecipitate is cut into bulk, are positioned in sanitation-grade plastics bag.Both are all positioned in less than-70 DEG C refrigerators.
The cryoprecipitate of 6, getting above-mentioned two kinds for the treatment of process gained respectively detects tires, and titration method is with reference to human blood coagulation factors VIII Determination method (first phase method) in " Chinese Pharmacopoeia " version annex in 2010.Detected result is as follows:
7, according to comparing result, adopt treatment process of the present invention obviously to shorten due to the treatment time, gained cryoprecipitate is tired higher than ordinary method, effectively ensure that the activity of platelet cofactor Ⅰ in cryoprecipitate.
Embodiment 5
1, each 20kg of the cryoprecipitate for the treatment of process of the present invention and ordinary method gained is adopted in Example 4 respectively.
2, dissolve respectively with water for injection (volume ratio of cryoprecipitate and water for injection is 1:5-1:10); Ordinary method gained cryoprecipitate dissolution time is about 2 hours, and treatment process of the present invention is about 1 hour; 2% aluminium hydroxide 108g is added, precipitated impurities albumen by often liter of lysate.
3, GQ-142 type whizzer (producer: Shanghai centrifugal machine institute) is used to carry out centrifugal 1 ~ 3 hour with the speed of 10000-16000rpm to gained solution;
4, get supernatant liquor, according to " blood products removal/inactivation of viruses technological method and verification guide principle ", carry out S/D inactivation of virus, inactivator is 1% Polysorbate 80,0.3% tributyl phosphate, processes at least 6 hours after being added into centrifuged supernatant at 25 DEG C;
5, the liquid after inactivation of virus is through sepharose separation and purification.Loading and washing, elution flow rate are 1.0 ~ 3.0L/ minute, obtain human blood coagulation factors VIII stoste through washing wash-out.
The human blood coagulation factors VIII stoste that the cryoprecipitate of 6, getting two kinds of different treatment methods obtains measures tires, and result is as follows:
7, to sum up, in preparation process, treatment process gained cryoprecipitate of the present invention is when dissolving, block little, conveniently feed intake, large with lysate contact area, dissolution time is obviously fast than conventional treatment method gained cryoprecipitate, shortens the process time, decay of tiring is few, in addition cryoprecipitate itself is tired higher, and therefore income earner's platelet cofactor Ⅰ stoste is tired height, and average yield improves 24%.
In describing the invention, it will be appreciated that, term " " center ", " longitudinal direction ", " transverse direction ", " length ", " width ", " thickness ", " on ", D score, " front ", " afterwards ", " left side ", " right side ", " vertically ", " level ", " top ", " end " " interior ", " outward ", " clockwise ", " counterclockwise ", " axis ", " radial direction ", orientation or the position relationship of the instruction such as " circumference " are based on orientation shown in the drawings or position relationship, only the present invention for convenience of description and simplified characterization, instead of indicate or imply that the device of indication or element must have specific orientation, with specific azimuth configuration and operation, therefore limitation of the present invention can not be interpreted as.
In addition, term " first ", " second " only for describing object, and can not be interpreted as instruction or hint relative importance or imply the quantity indicating indicated technical characteristic.Thus, be limited with " first ", the feature of " second " can express or impliedly comprise at least one this feature.In describing the invention, the implication of " multiple " is at least two, such as two, three etc., unless otherwise expressly limited specifically.
In the present invention, unless otherwise clearly defined and limited, the term such as term " installation ", " being connected ", " connection ", " fixing " should be interpreted broadly, and such as, can be fixedly connected with, also can be removably connect, or integral; Can be mechanical connection, also can be electrical connection; Can be directly be connected, also indirectly can be connected by intermediary, can be the connection of two element internals or the interaction relationship of two elements, unless otherwise clear and definite restriction.For the ordinary skill in the art, above-mentioned term concrete meaning in the present invention can be understood as the case may be.
In the present invention, unless otherwise clearly defined and limited, fisrt feature second feature " on " or D score can be that the first and second features directly contact, or the first and second features are by intermediary indirect contact.And, fisrt feature second feature " on ", " top " and " above " but fisrt feature directly over second feature or oblique upper, or only represent that fisrt feature level height is higher than second feature.Fisrt feature second feature " under ", " below " and " below " can be fisrt feature immediately below second feature or tiltedly below, or only represent that fisrt feature level height is less than second feature.
In the description of this specification sheets, specific features, structure, material or feature that the description of reference term " embodiment ", " some embodiments ", " example ", " concrete example " or " some examples " etc. means to describe in conjunction with this embodiment or example are contained at least one embodiment of the present invention or example.In this manual, to the schematic representation of above-mentioned term not must for be identical embodiment or example.And the specific features of description, structure, material or feature can combine in one or more embodiment in office or example in an appropriate manner.In addition, when not conflicting, the feature of the different embodiment described in this specification sheets or example and different embodiment or example can carry out combining and combining by those skilled in the art.
Although illustrate and describe embodiments of the invention above, be understandable that, above-described embodiment is exemplary, can not be interpreted as limitation of the present invention, and those of ordinary skill in the art can change above-described embodiment within the scope of the invention, revises, replace and modification.
Claims (10)
1. for the treatment of a device for cryoprecipitate, it is characterized in that, comprising:
Pallet, limits cryoprecipitate spatial accommodation in described pallet;
Net cutter, described net cutter mates with described pallet, is suitable for inserting in described cryoprecipitate spatial accommodation;
Cover plate, described cover plate mates with described pallet, is suitable for closed described cryoprecipitate spatial accommodation.
2. the device for the treatment of cryoprecipitate according to claim 1, is characterized in that, described net cutter is arranged on the lower surface of described cover plate, and optionally, described cover plate upper surface is provided with handle.
3. the device for the treatment of cryoprecipitate according to claim 1 and 2, is characterized in that, comprise further:
Web member, described web member is connected with pallet with cover plate respectively,
Buckling piece, described buckling piece is connected with pallet with cover plate respectively,
Preferably, described web member is hinge.
4. the device for the treatment of cryoprecipitate according to any one of claim 1-3, is characterized in that, described net cutter is made up of multiple blade, and the multiple grid of described multiple blade formation arranged in a crossed manner,
Optionally, described multiple grid separately forms square, Polygons or circle;
Optionally, described multiple grid separately has the area of 1-6.25 square centimeter;
Optionally, described blade comprises horizontal blade and longitudinal blade, described horizontal blade and described longitudinal blade arranged in a crossed manner;
Optionally, in described horizontal blade and described longitudinal blade intersection arranged in a crossed manner, described horizontal blade and described longitudinal blade one of are at least formed with otch.
5., according to the device for the treatment of cryoprecipitate described in claim 4, it is characterized in that, comprise further:
Guide, described guide is arranged on the internal surface of described pallet side wall, and the described mesh fitting of described guide and described net cutter pre-position.
6. the device for the treatment of cryoprecipitate according to any one of claim 1-5, is characterized in that, described pallet, described net cutter and described cover plate are separately made up of stainless steel, and preferably, described stainless steel is 316 stainless steels.
7. prepare a method for cryoprecipitate, it is characterized in that, comprise the following steps:
(1) pre-treatment: after freezing blood plasma is melted in advance, stir, and keep the blood plasma temperature 0-8 degree Celsius after melting in advance, to obtain pretreated blood plasma;
(2) collecting precipitation: by pretreated blood plasma feed liquor speed be 1-2.5L/ platform/point under carry out centrifugal so that obtain precipitation;
(3) cutting precipitation: adopt described in any one of claim 1-6 for the treatment of cryoprecipitate device process described in precipitate, to obtain the precipitation after cutting;
(4) freeze forming: the device containing the precipitation after described cutting is positioned over less than-70 DEG C and carries out freeze forming, to obtain cryoprecipitate.
8. method according to claim 7, is characterized in that, described step (3) comprises further:
(3-1) described precipitation is cut off be laid in described in any one of claim 1-6 for the treatment of in the described pallet in the device of cryoprecipitate;
(3-2) by being positioned over fast on pallet for the treatment of the net cutter in the device of cryoprecipitate described in any one of claim 1-6, described cover plate is fastened simultaneously.
9. prepare a method for cryoprecipitate, it is characterized in that, comprise the following steps:
(1) pre-treatment: after freezing blood plasma is melted 12-26 hour in advance at-5-5 DEG C, stir, and keep the blood plasma temperature 0-8 DEG C after melting in advance, to obtain pretreated blood plasma;
(2) collecting precipitation: feed liquor speed be 1-3.5L/ platform/point, going out liquid temp is, at 0-8 DEG C, pretreated blood plasma is carried out centrifugal 5-15 minute, so as to obtain precipitation;
(3) cutting precipitation: adopt described in any one of claim 1-6 for the treatment of cryoprecipitate device process described in precipitate, to obtain the precipitation after cutting;
(4) freeze forming: the device containing the precipitation after described cutting is positioned over less than-70 DEG C and carries out freeze forming, to obtain cryoprecipitate.
10. method according to claim 9, is characterized in that, described step (3) comprises further:
(3-1) described precipitation is cut off be laid in described in any one of claim 1-6 for the treatment of in the described pallet in the device of cryoprecipitate;
(3-2) by being positioned over fast on pallet for the treatment of the net cutter in the device of cryoprecipitate described in any one of claim 1-6, described cover plate is fastened simultaneously.
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| CN201511004902.3A CN105481939A (en) | 2015-12-28 | 2015-12-28 | Device for treating cryoprecipitate and method for preparing cryoprecipitate |
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