A kind of powder
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Liquid double-chamber transfusion bag and preparation method thereof
Technical field
The present invention relates to a kind of powder-liquid double-chamber transfusion bag, and the preparation method of this powder-liquid double-chamber transfusion bag.
Background technology
Powder-liquid double-chamber transfusion bag product is a kind of immediate dispensing infusion product, packaging material powder-liquid the double-chamber transfusion bag of this series products means and is combined into bag surrounding by multilayer co-squeeze film for transfusion by real welding heat, is closed the transfusion bag that (can press and open) separation inner space is made with weak welding heat, and two chambers of this transfusion bag can be respectively used to liquid drug and aseptic powder.Before transfusion, operator only need to apply certain pressure to sap cavity bag, is opened at weak weldering position and makes two chambers through and shake up, so that sterile liquid medicine is sufficiently mixed with aseptic powder and dissolves, can carry out clinical transfusion subsequently after the suspension of this transfusion bag.Compared with traditional infusion bag, powder-liquid double-chamber transfusion bag has the advantage that on Clinical practice (1) clinical treatment, without error of making up a prescription, prevents nosocomial infection, makes up a prescription room without special sterile when making up a prescription, and uses very convenient, safety;(2) can significantly shorten incorporation time of making up a prescription, improve medical personnel's work efficiency;(3) can reduce medicine in intermediate links and the storage area of medical institutions, reduce Biohazard Waste;(4) be particularly well-suited to speedily carry out rescue work, the disaster relief, emergent, field relief, the occasion such as war.
The manufacture of powder-liquid double-chamber transfusion bag need to use dedicated film material, common multilayer co-squeeze film for transfusion cannot use owing to can not realize weak weldering, at present, on medical packaging market, can be used for manufacture powder-liquid double-chamber transfusion bag film material mainly have two kinds: a kind of be internal layer material be the multilayer co-squeeze film for transfusion of polyethylene;Another kind be internal layer material be polyacrylic multilayer co-squeeze film for transfusion.Above two film material all can realize weak being welded and produce the powder-liquid double-chamber transfusion bag meeting Clinical practice requirement.
Although above two dedicated film material can realize weak being welded and produce powder-liquid double-chamber bag, but limit range because of the defect of respective material own, wherein, internal layer material is that the film material of polyethylene is preferable with the major part powder injection formulation compatibility, list for many years in Japan, but it is not resistant to the terminal sterilization (such as: 121 DEG C, 12 minutes) of injection requirement due to it, cannot promote the use of at home;Internal layer material be polyacrylic film material then because polypropylene material itself is containing big weight oligomers, the best with the major part powder injection formulation compatibility, and use limited.
Summary of the invention
The problem existed for prior art, the primary and foremost purpose of the present invention is to provide a kind of powder-liquid double-chamber transfusion bag, intends to solve that existing powder-liquid double-chamber bag product causes using limited problem because of the film defect of material material own.The secondary objective of the present invention is to provide the preparation method of a kind of powder-liquid double-chamber transfusion bag.
For achieving the above object, the technical solution of the present invention is:
A kind of powder-liquid double-chamber transfusion bag, this transfusion bag includes flour bag and liquid bag, described flour bag is separated by least one weak welding rod mutually with described liquid bag, the bag wall of this transfusion bag is made up of the PP TYPE material at least provided with inside and outside two-layer, wherein, the internal layer of liquid bag is made up of polypropylene/modified polypropylene, and the internal layer of flour bag is made up of polyethylene/modified poly ethylene, and the place of joining of the internal layer of liquid bag and the internal layer of flour bag is provided with co-extrusion fusion portion.
Further, the side in described co-extrusion fusion portion is close to by weak welding rod described in one or more in being arranged on described liquid bag chamber.
Further, described liquid bag is provided with plastic interface, described plastic interface is welded with plastic closure.
Further, the bag wall of described liquid bag and described flour bag is provided with three layers, is additionally provided with polypropylene/modified polypropylene middle level and polypropylene/modified outer layer of polypropylene outside the internal layer of transfusion bag.
Further, the bag wall of described liquid bag and described flour bag is provided with five layers, outside the internal layer of transfusion bag, it is additionally provided with polypropylene/modified polypropylene middle level and polypropylene/modified outer layer of polypropylene, between internal layer and the described polypropylene/modified polypropylene middle level of transfusion bag, between polypropylene/modified polypropylene middle level and described polypropylene/modified outer layer of polypropylene, accompanies adhesive phase.
Further, outside described flour bag, it is welded with the aluminum-plastic composite membrane being coated with, described aluminum-plastic composite membrane offers suppending hole.
The preparation method of a kind of above-mentioned powder-liquid double-chamber transfusion bag, described preparation method comprises the steps:
1) polypropylene/modified polypropylene fusion pellet and polyethylene/modified poly ethylene are melted after pellet crosses in coextrusion, formed the internal layer of co-extrusion film material by internal layer sub-runner coextrusion, and form co-extrusion fusion portion in the two intersection, the outer layer of co-extrusion film material melts pellet and is extruded into the outer layer of described co-extrusion film material, the most inside and outside two-layer of co-extrusion film material through the outer layer sub-runner of described coextrusion;
2) take the co-extrusion film material prepared and make bag blank by heat seal welding, the weak welding rod that bag inner chamber is separated into flour bag and liquid bag it is welded with in the side heat seal being close to described co-extrusion fusion portion, wherein, the internal layer of described liquid bag is polypropylene/modified polypropylene, and described flour bag internal layer is polyethylene/modified poly ethylene;
3) in liquid bag chamber, pour into medicinal liquid, sterilizing after fill, be dried, then in flour bag chamber inject medicated powder, after fill seal.
Further, the described polypropylene/modified polypropylene fusion pellet in step 1) and described polyethylene/modified poly ethylene melt pellet and are respectively prepared by two pellet extruders.
Further, in described coextrusion, the quantity of sub-runner determines the number of plies of described co-extrusion film material, and it is polypropylene/modified polypropylene that the outer layer of co-extrusion film material melts pellet.
Further, also include that step 4) is welded with the aluminum-plastic composite membrane being coated with outside flour bag, described aluminum-plastic composite membrane offers suppending hole.
The powder of the present invention-liquid double-chamber transfusion bag solves the dilemma being used alone polyethylene or polypropylene as chamber internal layer, using polyethylene/modified polyethylene film material as the internal layer of flour bag, film material and medicated powder have the preferable compatibility, using polypropylene/modified polypropylene screen material as the liquid bag internal layer needing terminal sterilization, the requirement of terminal sterilization can be born, during use, extrude at weak welding rod, make weak welding rod collapse and convince logical flour bag and liquid bag by patient analysis, make the aseptic mixing of powder liquid;The weak welding rod of multiple tracks is set it can be avoided that at pilot processs such as storage, transports, because pressure infuser bag causes the problem that weak welding rod collapses out by mistake;Multilayer bag wall makes transfusion bag more solid, and barrier more preferably, and does not interferes with the terminal sterilization of liquid bag;Aluminum-plastic composite membrane meets the requirement of flour bag Chinese medicine powder lucifuge storage, and convenient hanging.
Accompanying drawing explanation
Fig. 1 is the first structural representation of the powder-liquid double-chamber transfusion bag of the present invention;
Fig. 2 is the view profile in Fig. 1 at B-B;
Fig. 3 is the top view of double-layer coextrusion film material;
Fig. 4 is the view profile in Fig. 3 at A-A;
Fig. 5 is the view profile of three-layer extrusion film material;
Fig. 6 is the view profile of five-layer co-squeezing film material;
Fig. 7 is the second structural representation of the powder-liquid double-chamber transfusion bag of the present invention;
Fig. 8 is the view profile in Fig. 7 at C-C;
Fig. 9 is the third structural representation of the powder-liquid double-chamber transfusion bag of the present invention;
In figure: 1 liquid bag, 2 flour bags, 3 weak welding rods, 4 transfusion bag outer layers, 4-1 modified polypropene middle level, 4-2 modified polypropene outer layer, 4-3/4-5 adhesive phase, 4-4 polypropylene middle level, 4-6 outer layer of polypropylene, 5 liquid bag internal layers, 6 flour bag internal layers, 7 co-extrusion fusion portions, 8 transfusion bag internal layers, 9 plastic interfaces, 10 plastic closures, 11 transition regions, 12 aluminum-plastic composite membranes, 13 suppending holes.
Detailed description of the invention
Below, with reference to accompanying drawing, the present invention is more fully illustrated, shown in the drawings of the exemplary embodiment of the present invention.But, the present invention can be presented as multiple multi-form, is not construed as the exemplary embodiment being confined to describe here.And it is to provide these embodiments, so that the present invention is fully and completely, and will fully convey the scope of the invention to those of ordinary skill in the art.
For ease of explanation, here can use such as " on ", the space relative terms such as D score " left " " right ", for shown in explanatory diagram a element or feature relative to another element or the relation of feature.It should be understood that in addition to the orientation shown in figure, spatial terminology is intended to include device different azimuth in use or operation.Such as, if the device in figure is squeezed, be stated as being positioned at the element of other elements or feature D score will be located into other elements or feature " on ".Therefore, exemplary term D score can comprise upper and lower both orientation.Device can otherwise position (90-degree rotation or be positioned at other orientation), relatively illustrates used herein of space correspondingly to explain.
Being the first specific constructive form of a kind of powder of the present invention-liquid double-chamber transfusion bag as depicted in figs. 1 and 2, this powder-liquid double-chamber transfusion bag includes the flour bag 2 on top and the liquid bag 1 of bottom.Liquid bag internal layer 5(is shown in Fig. 3) and flour bag internal layer 6(see Fig. 3) junction be provided with co-extrusion fusion portion 7.One weak welding rod 3 is set between flour bag 2 and liquid bag 1, weak welding rod 3 flour bag 2 chamber is separated mutually with liquid bag 1 chamber.Co-extrusion fusion portion 7 is arranged in flour bag 2 chamber to be close at weak welding rod 3.Weak welding rod 3 is the conjunction of bag wall pressure to be formed by heat seal welding, the bonding strength of bonding strength transfusion bag the to be far below periphery at weak welding rod 3.Liquid bag 1 lower end is provided with plastic interface 9, plastic interface 9 is welded with plastic closure 10.
As shown in Figure 3 and Figure 4 for making the double-layer coextrusion film material of transfusion bag bag wall, including transfusion bag internal layer 8 and transfusion bag outer layer 4, the material of transfusion bag outer layer 4 is polypropylene, transfusion bag internal layer 8 is made up of two kinds of materials, i.e. polypropylene and polyethylene, the material of liquid bag internal layer 5 is polypropylene, the material of flour bag internal layer 6 is polyethylene, the place of joining of liquid bag internal layer 5 and flour bag internal layer 6 is provided with co-extrusion fusion portion 7, and co-extrusion fusion portion 7 is to be co-extruded in coextrusion by both materials (polypropylene, polyethylene).
It is illustrated in figure 5 the three-layer extrusion film material making transfusion bag bag wall, including the transfusion bag internal layer 8(being made up of liquid bag internal layer 5, co-extrusion fusion portion 7 and flour bag internal layer 6 with reference to Fig. 4), outside transfusion bag internal layer 8, it is additionally provided with modified polypropene middle level 4-1 and modified polypropene outer layer 4-2.Than double-layer coextrusion film material, the transfusion bag bag wall that three-layer extrusion film material is made is thicker, and barrier is more preferably, more solid, not cracky.
It is illustrated in figure 6 the five-layer co-squeezing film material making transfusion bag bag wall, including the transfusion bag internal layer 8(being made up of liquid bag internal layer 5, co-extrusion fusion portion 7 and flour bag internal layer 6 with reference to Fig. 4), outside transfusion bag internal layer 8, it is additionally provided with two adhesive phase 4-3/4-5, polypropylene middle level 4-4 and outer layer of polypropylene 4-6.Than double-deck and three-layer extrusion film material, the transfusion bag bag wall that five-layer co-squeezing film material is made is thicker, and barrier is more preferably, more solid, not cracky.
Co-extrusion film material is not merely above-mentioned bilayer, three layers or five layers, it is also possible to be more layers.
It is the second specific constructive form of a kind of powder of the present invention-liquid double-chamber transfusion bag as shown in Figure 7 and Figure 8, this powder-liquid double-chamber transfusion bag is essentially identical with the first specific constructive form shown in Fig. 1 and Fig. 2, difference is, the second specific constructive form is provided with the weak welding rod of twice 3, it is provided with transition region 11 between the weak welding rod of twice 3, than the version arranging weak welding rod 3 together, the weak welding rod of twice 3 is it can be avoided that storing, the pilot processs such as transport, because pressure infuser bag causes wherein 3 problems collapsed out of weak weldering together by mistake, the isolation effect of liquid bag 1 and flour bag 2 can be further ensured that.
The weak welding rod of multiple tracks 3 can also be set certainly.
It is illustrated in figure 9 the third specific constructive form of a kind of powder of the present invention-liquid double-chamber transfusion bag, on the basis of the first and the second concrete structure, outside flour bag 2, it is welded with the aluminum-plastic composite membrane 12 being coated with, aluminum-plastic composite membrane 12 offers suppending hole 13.Aluminum-plastic composite membrane 12 meets the requirement of flour bag 2 Chinese medicine powder lucifuge storage, and suppending hole 13 facilitates transfusion bag hanging in use.
Embodiment
1
One of preparation method of powder-liquid double-chamber transfusion bag (two-layer co-extrusion film material):
Step 1) is respectively prepared polypropylene fusion pellet by two pellet extruders and described polyethylene melts pellet, polypropylene fusion pellet and polyethylene are melted after pellet crosses in coextrusion by internal layer sub-runner coextrusion, form the film material of the most inside and outside two-layer, wherein, liquid bag internal layer that the internal layer of co-extrusion film material is made up of polypropylene and the flour bag internal layer that polyethylene is made are constituted, and form co-extrusion fusion portion in the two intersection;The outer layer of co-extrusion film material, by an independent polypropylene material grain extruder feed, is extruded by the outer layer sub-runner of coextrusion, and the quantity of outer layer sub-runner determines the number of plies (with reference to Fig. 3 and Fig. 4) of outer layer.
Step 2) take the co-extrusion film material surrounding for preparing and make bag blank by heat seal welding, it is welded with weak welding rod being close to co-extrusion fusion portion's heat seal, flour bag internal layer and liquid bag internal layer are separated at two chambers, co-extrusion fusion site is in flour bag chamber;At liquid bag top welding plastic interface, for liquid drug, injecting a certain amount of sterile nitrogen flour bag one jiao by injection device, then heat seal seals decanting point.
Step 3) pours into 0.9% sodium chloride injection by the plastic interface welded in advance in liquid bag, after fill completes, seals lid at plastic interface top welding plastic, then semi-finished product is delivered to bactericidal unit, sterilizing 12 minutes under 121 DEG C of high temperature.After sterilizing completes, it is dried process in semi-finished product are placed in air dry oven, baking temperature is 80 DEG C, 1.5 hours drying times, after being dried, move to medicated powder fill operation, flour bag 2 base cuts first will closed, drain nitrogen, fill lactobionic acid azithromycin for injections, then bottom welding is closed.
Step 4) is respectively welded aluminum-plastic composite membrane at flour bag front and the back side, a die-cut elliptical aperture on aluminum-plastic composite membrane top.
Powder-liquid double-chamber bag dress lactobionic acid azithromycin for injections/sodium chloride injection sample will be prepared be placed under 60 DEG C of environment acceleration and investigate, and sample respectively at 5 days, 10 days, by Chinese Pharmacopoeia standard, flour bag content medicine is carried out key index detection, result such as following table:
Table 1 lactobionic acid azithromycin for injections accelerates to investigate result
Result shows, uses the lactobionic acid azithromycin for injections/sodium chloride injection of a kind of powder of the present invention-liquid double-chamber bag packaging, accelerates to investigate 10 days through 60 DEG C, clarity of solution, medicament contg, has related substance all to meet Chinese Pharmacopoeia standard-required.
Embodiment
2
Two (three-layer extrusion film materials) of the preparation method of powder-liquid double-chamber transfusion bag:
The two of method are with the difference of one of method, co-extrusion film material uses three layers, increase a material grain extruder, pellet is melted for extruding polypropylene middle level, the quantity of outer layer sub-runner determines the number of plies of outer layer, the outer layer of co-extrusion film material is made up of modified polypropene middle level and modified polypropene outer layer, and liquid bag internal layer that the internal layer of co-extrusion film material is made up of modified polypropene and the flour bag internal layer that polyethylene is made are constituted, and form co-extrusion fusion portion in the two intersection;(with reference to Fig. 5).
Powder-liquid double-chamber bag dress ceftriaxone sodium for injection/sodium chloride injection sample will be prepared be placed under 60 DEG C of environment acceleration and investigate, and sample respectively at 5 days, 10 days, by Chinese Pharmacopoeia standard, flour bag content medicine is carried out key index detection, result such as following table:
Table 2 ceftriaxone sodium for injection accelerates to investigate result
Result shows, uses the ceftriaxone sodium for injection/sodium chloride injection of a kind of powder of the present invention-liquid double-chamber bag packaging, accelerates to investigate 10 days through 60 DEG C, clarity of solution, medicament contg, has related substance all to meet Chinese Pharmacopoeia standard-required.
Embodiment
3
Three (five-layer co-squeezing film materials) of the preparation method of powder-liquid double-chamber transfusion bag:
The three of method with the two of method difference be, co-extrusion film material uses five layers, increase by two adhesive layer pellet extruders, pellet is melted for extruding both adhesive layers, the quantity of outer layer sub-runner determines the number of plies of outer layer, and the outer layer of co-extrusion film material is by two adhesive phases arranged outside transfusion bag internal layer, modified polypropene middle level and modified polypropene outer layer (with reference to Fig. 6).
Powder-liquid double-chamber bag dress fosfomycin sodium for injection/glucose injection sample will be prepared be placed under 60 DEG C of environment acceleration and investigate, and sample respectively at 5 days, 10 days, by Chinese Pharmacopoeia standard, flour bag content medicine is carried out key index detection, result such as following table:
Table 3 fosfomycin sodium for injection accelerates to investigate result
Result shows, uses the fosfomycin sodium for injection/glucose injection of a kind of powder of the present invention-liquid double-chamber bag packaging, accelerates to investigate 10 days through 60 DEG C, and clarity of solution, medicament contg all meet Chinese Pharmacopoeia standard-required.