CN1082881A

CN1082881A - Multi cavity container

Info

Publication number: CN1082881A
Application number: CN93106347A
Authority: CN
Inventors: 井上富士夫; 泉雅满; 山薰明
Original assignee: Otsuka Pharmaceutical Factory Inc
Current assignee: Otsuka Pharmaceutical Factory Inc
Priority date: 1992-05-03
Filing date: 1993-05-03
Publication date: 1994-03-02
Anticipated expiration: 2013-05-03
Also published as: PH31343A; SG44684A1; GR3031088T3; AU4270993A; EP0639364B1; JPH0614975A; CA2112661A1; NO303815B1; AU654442B2; DE69325801T2; EG20103A; RU2103987C1; NO934910D0; TW216768B; PL172973B1; FI935972A; ATE182464T1; PL298768A1; ES2133399T3; DE69325801D1

Abstract

A kind of multi cavity container that is mainly used in the field of medicaments.The container body is made by flexiplast, and has the separating device that the container body is divided into many chambeies and allows when needed to be communicated with between each chamber.At least one chamber is surrounded by a coverlay to form the space of a sealing in film around chamber.Coverlay is to be made by a kind of fexible film that moisture and gas is had barrier properties.This container is very cheap, has high-quality and can use effectively and be convenient to abandon.

Description

Multi cavity container

The present invention relates to be mainly used in the multi cavity container of field of medicaments, and relate more specifically to be used for the flexible multi-cavity plastic containers of receiving fluids preparation, powder formulation or solid preparation, and the separating device that container is separated into several chambeies and allows each chamber to be communicated with when needing.

Flexible plastic container has been used to field of medicaments before this, the separating device that wherein has a plurality of chambeies and container is separated into a plurality of chambeies and allows to be interconnected between each chamber.Because even this container might allow very a spot of moisture or gas to enter, therefore be used to become the in time unsettled a kind of antibiotics or the similar medicine of reaching of preserve separately moisture absorption when container, and liquid preparation is (as normal saline, Glucose Liquid or similar solution or diluent) time, just container need be put into the outer bag that moisture and gas are had barrier properties of a costliness with desiccant.However, the desiccant that absorbs moisture from liquid preparation can not be fully with hygroscopic pharmaceutical drying, and has further caused concentrating of liquid preparation.Because this defective, in practice can't be in flexible plastic container with hygroscopic and unstable antibiotics or similar medicine and liquid preparation preserve separately.

For this reason, the unsettled medicine (as antibiotics) that becomes in time is stored before use in the liquid medicine bottle or similar containers of water-tight branch and gas.In the time will inputing to patient, with the normal saline of medicine and preserve separately, glucose solution or similarly lysate or mixing diluents or with their dilutions or be dissolved in wherein.

Yet this method implements pretty troublesome and the danger of bacterial infection is arranged in operating process.Therefore, people improve container, container after the improvement comprises a glass medicine bottle, a kind of unstable antibiotics wherein is housed, with a flexible plastic container part that solution is housed that connects together with medicine bottle, between medicine bottle and container, be provided with a puncture needle (for example, seeing the open HEI 2-1277 of unexamined Japanese Patent Laid).The advantage of these containers is that its inclusions can mix easily under aseptic condition, and need a very complicated process for abandoning container because container is separated into glass medicine bottle, flexible container part and Centesis instrument, also have any problem when therefore discarding container.So there is the medical problem that abandons at garbage in this container, that is, can not satisfy the problem of being convenient to abandon this requirement, this problem has been caused attention recently.

The known multi cavity container (for example, seeing the open 63-20550 of the Japanese Patent Laid of having examined) that also is useful on the medicine that holds other the easy oxidation Freamine of tryptophan and a kind of sugar or electrolyte (as contain).This class container must be placed in the outer bag of the gentle body of isolation moisture of a costliness with a kind of oxygen absorbent.In this case, absorbent does not need the back a kind of preparation (sugar or electrolyte) to its generation effect to be inclusive in outer bag with medicine yet.Therefore, outer bag need have bigger capacity, need have the oxygen absorbent of the absorbed dose of the ability to take oxygen of increase or increase, and the material of more substantial isolation moisture and gas, therefore has the shortcoming that increases cost.

An object of the present invention is to provide a kind of that have a multi-cavity and can be used for holding and preserve hygroscopic or be easy to the flexible plastic container of liquid preparation, powder formulation or the solid preparation of oxidation.

Another object of the present invention provides a kind of like this container, i.e. the amount of the film of the gentle body of isolation moisture of the costliness that the preparation of this container is adopted can reduce, and is cheap therefore.

A further object of the invention just provides a kind of container of mentioning that need not to comprise a glass medicine bottle, therefore is convenient to abandon.

Another object of the present invention provides liquid, powder or the solid pharmaceutical preparation that a kind of like this container wherein contains a kind of hygroscopicity or easily oxidation at least one chamber, it is isolated with outside moisture and oxygen having only this chamber, and is suitable for preventing the preparation oxidation or absorbs moisture content and need not pack into any oxygen absorbent or desiccant.

Further feature of the present invention will become apparent from the following description.

The invention provides a kind of container, it has can hold a kind of liquid, powder or solid a plurality of chamber and the separating device that container is separated into a plurality of chambers and allows when needing to be communicated with between each chamber, this container is characterised in that: container comprises a flexible plastic container body that constitutes multi-cavity, one of them chamber surrounds with a coverlay, this film has the periphery of sealing to form the space of a sealing around chamber, and other chamber does not have coverlay, coverlay is had the elastica that stops moisture content and air performance and is made by a kind of, separating device is made of at least one weak seal section branch, and this part can be opened with the internal pressure that applies an increase at an easy rate by pressing cavity.

Adopt container of the present invention, can be with a kind of ordinary matter, as a kind of liquid, powder or the solid preparation that are difficult for oxidation or no hygroscopicity are put into the intracavity of each no coverlay in chamber of container.This chamber need not stop that the coverlay of the gentle body of moisture content surrounds, and therefore have the lower ability that stops the gentle body of moisture content, and because this material is a kind of ordinary matter, this material that is contained in the container can be preserved a very long time in the common plastics container.

On the other hand, with a kind of particular matter, as be easy to oxidation and/or have hygroscopic liquid, powder or solid preparation put into covering membrane-enclosed intracavity.The container body that constitutes chamber is made of plastics, and has the inherent permeability to moisture content and gas of plastics (although permeability is very low) and moisture content and gas are had lower barrier properties.Yet, the film that surrounds chamber is to be made by the special film of waterproof part and gas, therefore, although plastic container body has lower barrier properties to moisture content and gas, and this particular matter can be deposited one section long time and non-degradable (degradation).

Therefore, although made by flexiplast, container of the present invention can be without any being used for holding hygroscopic troublesomely and the unsettled medicine that becomes in time, as antibiotics, and liquid preparation, as lysate or diluent.

Container of the present invention has air-locked coverlay of being made by the special thin film of costliness, but therefore coverlay, can constitute with a small amount of expensive special thin film only in the setting of the part of container.This is to drop to minimum for the increase with packing cost.Because need not to put into oxygen absorbent or desiccant in the coverlay around the container body, therefore, cost can further reduce.

A plurality of chambeies of container of the present invention are divided by at least one weak seal section and are isolated, and this part can be opened so that communicate with each other between each chamber by apply a pressure from the outside.Therefore, when not contacting outside air, ingredient can sterilely mix.The coverlay of plastic container body and formation container is flexibility and easily deformable, makes container needn't separate when being dropped, and therefore, is easier to abandon than the container that adopts glass or metal.

Fig. 1 is the vertical section diagrammatic sketch of the amplification of expression container according to an embodiment of the invention;

Fig. 2 is the front view of same container;

Fig. 3 is the profile of the amplification of part A among Fig. 1;

Fig. 4 is the profile of the amplification of part B among Fig. 1;

Fig. 5 is the profile of the amplification of portion C among Fig. 1;

Fig. 6 is the sketch map that a preferred embodiment of the process of making container shown in Figure 1 progressively is described;

Fig. 7 is the profile of a part of the plastic container body of container in accordance with another embodiment of the present invention;

Fig. 8 is the profile of a part of coverlay of container in accordance with another embodiment of the present invention;

Fig. 9 represents the vertical cross section of container in accordance with another embodiment of the present invention;

Figure 10 is the profile that weak seal section divides the amplification of another example;

Figure 11 is contained in an interior perspective view for the container of the present invention of depositing or transporting of outer bag;

Figure 12 represents the vertical section of the container of another embodiment according to the present invention;

Figure 13 is the sketch map that another preferred embodiment of the process of making container of the present invention progressively is described.

To contrast accompanying drawing below and describe embodiments of the invention.

Fig. 1 and 2 represents to have those class one embodiment of the present of invention that two weak seal sections divide.

With reference to Fig. 1 of this embodiment of expression, 1 represents a flexible plastic container, and it has a disengaging section 2.

Plastic container body 1 is made by the flexible plastic film 3 of two superimposed, by heating two membranes is sealed along its neighboring.

Thin film 3 is not special thin film, just is used to make a kind of cheap plastic sheeting of flexible plastic container usually in field of medicaments.

Fig. 3 represents to comprise an example of two-layer thin film 3, i.e. the outer 3a of a polyethylene (after this being called for short " PE ") and an internal layer 3b who is made of PE and polypropylene (after this being called for short " PP ") mixture.

As referring to Fig. 1, plastic container body 1 has two middle parts at container height to prolong the weak seal section container horizontal expansion and that adopt heated sealant to form to divide 8a, 8b.

Weak seal section divides 8a, 8b to be suitable for when needed, by squeeze receptacle its internal pressure is increased relative thin layer is separated from each other.The sealing intensity that weak seal section divides must be less than the sealing intensity of container body 1 peripheral part.

The inside of plastic container body 1 is divided 8a, 8b to be divided into upper and lower two chamber 1a, 1b by weak seal section.The container top 1A that constitutes epicoele 1a surrounds with a coverlay 5, and the container bottom 1B that constitutes cavity of resorption 1b then is not provided with this coverlay 5.

Coverlay 5 is made by the special thin film 6 of a kind of waterproof part and gas.Fig. 5 has represented an example of this special thin film 6,, has a kind of plural layers of the internal layer 6b that an outer 6a and is made of PE that is.Outer 6a is a kind of aluminum coverlay, as is surrounded by the thin film of aluminium flake, and a kind of have highly waterproof and airproof aluminizer, or a kind of bilayer film that is made of polyvinylidene chloride and polypropylene (PP).The polyvinylidene chloride that constitutes outer 6a can substitute with a kind of polyvinyl alcohol film that scribbles silicon.

With reference to Fig. 1, coverlay 5 comprises the two-layer special thin film 6 that is provided with around container top 1A.In the peripheral part of each layer film 6, those parts of contacting container top 1A are not by heated sealant each other, and those parts of contacting container top 1A are heated outer surface (as 6c, shown in the 6c) sealing with part 1A.As see Fig. 1, and adherent following

part

6c, 6c is positioned at weak seal section and divides 8a, between the 8b.

Basically a packing less slit part 9 is arranged between hermetic unit 8a, 8b.Fig. 4 has represented the contact of heated sealant in the ratio of amplifying.The following part 6c heated sealant of coverlay 5 is on the slit part 9 between hermetic unit 8a, the 8b.So just got rid of the possibility that heated sealant makes weak seal section divide the sealing intensity of 8a, 8b to increase.Under the situation of single hermetic unit type, on the container body 1 of the following part heated sealant of coverlay 5 on weak seal section divides.Therefore, wish, prevent that promptly the sealing intensity that weak seal section divides is increased to a possible extent in a kind of like this condition lower seal marginal portion, even sealing intensity increases in other words, also can be without any easily hermetic unit being separated troublesomely.This condition can decide by material and the definite heated sealant condition (as temperature, time and pressure) of suitably selecting coverlay, so just relates to considerable restriction.Under the situation of the Fig. 1 and the embodiment of the invention shown in Figure 4, the following part 6c of coverlay 5 can be sealed on the container body 1 and can not influence the sealing intensity that weak seal section divides 8a, 8b conversely.Like this, compare, just produced superiority, but promptly the choice of the material of coverlay 5 and air-proof condition is bigger with the situation of single hermetic unit.And employing embodiments of the invention, promptly wherein the following part 6c of coverlay 5 is sealed in two weak seal sections and divides on the slit part 9 between 8a, the 8b, the position of the sealed contacts of following part 6c is farther apart from chamber 1a, the 1b of container body, as being clear that from Fig. 4.Heat when having got rid of sealing makes the pharmaceutical preparation heat that is contained among chamber 1a, the 1b probability to degraded like this.Pharmaceutical preparation hygroscopic or that be easy to oxidation comprises many pharmaceutical preparatioies that are easy to the thermic degraded, and the following part of coverlay 5 can be heated and is sealed on the container body and can not produce probability to this preparation thermic degraded.Even one during two weak seal sections divide has been opened, another part can prevent that also two chambeies from communicating with each other.

For example, a kind of powder formulation 10 hygroscopic and/or that be easy to oxidation is put into the container top 1A that is capped, and (for example a kind of common liq preparation 11) put into unlapped container bottom 1B.

The temperature that forms sealing is the highest for all peripheral parts of plastic container body 1 and the top part and the lateral section of coverlay 5, temperature is inferior high the bottom of the coverlay 5 on being sealed in container body 1, and dividing 8a for weak seal section, 8b, seal temperature are minimum.As a result, in all hermetic units, weak seal section divides 8a, and the bonding strength of 8b is minimum.

Fig. 6 represents to make a preferred embodiment of the method for container of the present invention shown in Fig. 1 and 2.With reference to Fig. 6, (a)～(e) this method is described below.

At first as Fig. 6, (a) shown in, two layers of plastic thin films shown in Figure 3 is stacked together each other, makes

internal layer

3b, 3b contacts with each other, with three limits of assembly under about 170 ℃～200 ℃ temperature heated sealant to make a plastic container body 1.Then, under about 110 ℃～130 ℃ temperature, form weak seal section at the middle part of container body and divide 8a, 8b, and a disengaging section 2 is contained in body.What form subsequently is one and produces the container top 1A of epicoele and isolated and the container bottom 1B of a cavity of resorption is provided with part 1A.

Subsequently, by the unsealing part a kind of liquid preparation 11 is injected container bottom 1B.As see Fig. 6, (b), with two part 1A of container, the unsealing of 1B partly seals, and uses high compressed steam, hot water or similar substance heating disinfection subsequently.

Then, then the side of container top 1A is severed (as seeing Fig. 6, (c)) under gnotobasis, after this, when needs, can carry out drying so that this is partially opened.

Then as Fig. 6, (d) shown in, adopt special thin film as shown in Figure 5 a coverlay 5 to be set and heated sealant on its three limits in the outside of container top 1A.Divide 8a along weak seal section, the following part 6c that 8b extends is heated sealing to avoid following heated sealant ply partly on weak seal section divides at the zone line between two parts 8a, the 8b under about 130 ℃～135 ℃ temperature.Coverlay 5 stays open equally corresponding to that side that container top 1A opens a side.

At last, under gnotobasis, in the 1A of container top, put into a kind of powder formulation 10,, after this, part 1A and coverlay 5 are being opened a side seal as a kind of antibiotics.Fig. 6 (e) then represents container that obtain at last and that have two chambeies.

Hope before opening is sealed with the air N in the slit ₂What replace removes deoxidation.For example, can form the weak seal section branch by the mold that heads on a heated sealant formation of container body extruding with a cylindrical appliance.This mold can have the ridge-like structure that also can be heated to a controlled temperature with two preset distances that separate each other with an electric heater.

The method that can adopt (for example) to be similar to give an example the front is put into the container part 1A of coverlay with a kind of liquid preparation, and a kind of liquid or powder formulation is put into the container part 1B of no coverlay.The container that contains these preparations can so prepare, being about to a disengaging section 2 is contained on the container body, then specific formulation is put into container part 1A separately, 1B, the sealing medicine containing opening carries out disinfection to its inclusions with autocrave, then coverlay 5 is contained in container top 1A, after this, the side openings of sealing coverlay.

Adopt container of the present invention by method preparation shown in Figure 6, its top 1A is made of a kind of plastic sheeting, this film comprises the outer and internal layer that is made of PE and PP mixture of a PE, makes container top 1A allow moisture content and gas (as oxygen) to pass through, although be very a spot of.Yet container top 1A is provided with one by having after the coverlay 5 that the special thin film that stops the gentle body performance of moisture content constitutes, and this coverlay 5 has played the effect of the above-mentioned shortcoming that overcomes container top 1A.Therefore, although container top 1A is made of plastics, the powder formulation with hygroscopicity and/or easily oxidation can be preserved a very long time therein.In all hermetic units, on the partitioned bottle, the weak seal section of

bottom

1A, 1B divides 8a, and the 8b sealing intensity is minimum.Therefore, when squeeze receptacle partly makes its internal pressure increase, the pressure that increases makes

part

8a, 8b separates allowing two

container part

1A, 1B to communicate with each other, and then the liquid in each

container part

1A, 1B and powder formulation can mix the solution that forms a kind of expection under aseptic condition.

The example that is used for the powder formulation of top embodiment is hygroscopic and is easy to oxidation and is easy to antibiotic, anticancer, steroid, antithrombotic formation, solution fibrin, vitamin and the similar formulations of thermic degraded.Example as liquid preparation is a normal saline, glucose solution and similar lysate or diluent.

Though being used to make the general thin of plastic container body is the plural layers with structure shown in Figure 3, also can be with the thin film by at least a resin combination preparation in the mixture that is selected from PE, PP and these resins of single or multiple lift.

Fig. 7 has represented a kind of example of three-layer thin-film 35, comprising a skin 31 that constitutes by straight-chain low density polyethylene (after this being called for short " LLDPE "), an intermediate layer 33 that constitutes by LLDPE and the elastomeric resin compound of low crystalline (or amorphous) ethylene/alpha-olefin, and an internal layer 34 that constitutes by the resin compound of LLDPE and PP.

Further depend on the kind of the pharmaceutical preparation of being packed into, the low molecular weight substance that is comprised among the LLDPE in being present in the internal layer of inwall might produce with preparation within a period of time and react to each other, may produce a kind of product that patient is had otherwise impact, therefore, the LLDPE that is used for internal layer 34 will be at high temperature and vacuum, utilize devolatilization (devolatilization) and stripping process (stripping process) to carry out pretreatment, with this inclusions in low molecular weight substance is up to about 30 carbon atoms and is reduced to and is not higher than a particular value, and then prevented the reaction between pharmaceutical preparation and the internal layer effectively.

Further, when needs improve the heat resistance of thin film and when will an amount of high density polyethylene (HDPE) (HDPE) adding in each layer in the three-layer thin-film 35, formed container has under the high temperature of 121 ℃ (for example, with high compressed steam or hot water) stand disinfectant stability at least.

As the special thin film that forms covered film, might adopt by polyvinylidene chloride, polyethylene terephthalate (PET), metallized film, ethylene alcohol copolymer (EVOH) or be coated with the single or multiple lift diaphragm that silicon thin film constitutes.Preferably, owing to be coated with the transparency of silicon thin film and to the high barrier property of moisture content and gas, so it is used to form at least one tunic sheet.

Fig. 8 has represented the block film of a kind of waterproof part and gas, with a example as this thin film, promptly, comprise a skin that constitutes by the PET thin film of biaxial orientation 43, one in the three-layer thin-film 46 by being coated with an intermediate layer 44 that silicon PVA thin film constitutes and an internal layer 45 that constitutes by low density polyethylene (LDPE) (LDPE), and wherein these layers adhere to each other with the urethanes adhering resin.In the time the coverlay direct heating will being sealed to the plastic containers body, wish to adopt multilayer film at least as coverlay, so that the outermost material of the material of coverlay innermost layer and plastic container body is with a kind of material, and then form satisfied heat sealing layer.For example, when the outermost layer of container body is LLDPE, then wish the innermost layer as coverlay with LLDPE.

According to the embodiment of front, have in the chamber of the container part of coverlay though powder formulation has been packed into, and liquid preparation has been packed in the chamber of no coverlay container part,, can be according to intended purposes, with powder formulation and liquid preparation exchange.

For example, liquid preparation is put into the container part of coverlay, and powder formulation is packed in another container part, in this case, liquid preparation is a kind of amino acid preparation or the similar substance that contains oriented cystine or the tryptophan that wherein adds and be easy to oxidation, and powder formulation is a kind of sugar, electrolyte or its mixture.

For example, the container part that a kind of liquid preparation is packed into and is capped, and another kind of liquid preparation is put into another container part, in this case, preceding a kind of liquid preparation is easy to oxidation, as contain a kind of amino acid preparation of cystine or tryptophan, or a kind of vitamin preparation, then a kind of liquid system is sugar or electrolyte preparation.

Another example is such, that is, lipomul or similar substance that preceding a kind of liquid preparation is a kind of easy oxidation, then a kind of preparation are sugar or electrolyte preparation.

A kind of solid preparation of also might in a container part, packing into, and in another container part, put into a kind of liquid preparation.Other example of this powder, liquid and solid preparation is various vein input or nutritional preparation or the healing potion of importing (tube feed or oral) through intestinal.

Have, coverlay can be made to cover inner to avoid illumination by a kind of aluminizer partly or fully again.If necessary, the aluminizer as coverlay can be made into can or all tear by the part when preparation will be used.

Though the container among the embodiment of front has two chambeies that hold a kind of liquid preparation and a kind of powder formulation separately, this container can be separated into plural chamber, for example, and as shown in Figure 9.Be provided with one in coverlay 5 inside and have chamber 1a ₁, 1a ₂Container part 1A ', these two chambeies are used for putting into two kinds of powder formulations (or a kind of powder formulation and a kind of solid preparation).In the container part 1B of no coverlay, a kind of liquid preparation is housed.A plurality of chambeies might be provided for the liquid preparation except that powder or solid preparation, between these chambeies, be provided with the weak seal section branch.

In the chamber 1a of coverlay is arranged, be placed with under the situation of a kind of liquid, powder or the solid preparation that are easy to oxidation, wish a kind of noble gas of in the space of coverlay 5 inside around container body 1, packing into, as nitrogen, carbon dioxide gas or argon.When hygroscopic a kind of liquid, powder or solid preparation are housed among the 1a of chamber, then wish in the space, to be placed with a kind of dry air, exsiccant nitrogen or similar gas.When putting into noble gas, the air in the space is just replaced by noble gas, has so just guaranteed more effectively anti-oxidation.When packing dry gas into, the gas that is dried of the air in the space replaces, and has therefore increased moisture effect.

The waterproof and the gas-tight thin film of employing covering outside must moistureproof and anti-oxidation one or more chambeies, and further by noble gas or dry gas are put into around the space of container body coverlay on every side, then need not in the space, put into oxygen absorbent and/or desiccant as traditional occupation mode, no matter can make the pharmaceutical preparation time length that is contained in the container, all have advantages of higher stability.

Two weak seal section branches needn't always be arranged, but can be provided with more than two or a hermetic unit.And the weak seal section branch needn't be always rectilinear, and can be V-arrangement, so that roughly outstanding to the center that is capped the chamber.In this case, when applying a pressure with hands on a chamber, the active force of opening the weak seal section branch will concentrate on the V-shaped part, consequently, open the weak seal section branch with a less relatively pressure, pharmaceutical preparation can be mixed.Yet in this case, exist a kind of like this may, that is, and container deposit with transportation in, hermetic unit is accidental to break away from, and therefore wishes carefully definite heat seal condition.

Adopt the embodiment of front, the weak seal section branch is directly to stick together by two internal layers that will constitute the container body to form.Perhaps, the weak seal section branch can be by inserting film with two diaphragm heated sealants together with a multilamellar that is clipped between two diaphragms.Figure 10 represents a kind of improvement, its double-deck insertion film of having prized.3 expressions constitute the thin film of containers, and this is a kind of single or multiple lift thin film, and 18 are illustrated in a diaphragm that has high sealing intensity on the side of innermost layer of thin film 3, and 19 are illustrated in a diaphragm that has low sealing intensity on the opposite side of innermost layer of thin film 3.Film portion 3 and diaphragm 19 have constituted weak seal section and have divided 21a, 21b.For example, when thin film 3 was a kind of single thin film of being made by PE or PP, diaphragm 18 was by making with thin film 3 identical materials (being PE or PP), and diaphragm 19 is to be made by the mixture of PE and PP.Can insert thin film with two is used in respectively on two weak seal sections branches.Coverlay 5 can align with the weak seal section branch and carry out heated sealant, weak seal section is divided keep weak sealing state, perhaps can coverlay be connected on the container body with a kind of bonding agent or analog.

Container of the present invention is preferably in weak seal section and divides 8a, 8b place to be converted into two foldings and install with one outer bag 50 and deposit and transport.When being converted into for 2 whens folding, prevented because the pressure that the weight of the container that stacks causes or because the collision that produces of dropping makes the hermetic unit disengagement.

As shown in figure 12, form on the end of chamber 1a ' dismounting mouthfuls 2 ' can powder formulation 10(such as antibiotics be housed).In this case, 16 in the chamber that contains liquid preparation (as a kind of lysate) is closed.If on the chamber that a kind of liquid (as a kind of lysate) is housed, form the dismounting mouth, will there be a kind of danger, promptly under the situation of particularly urgent, only will not input to patient unintentionally with the blended liquid of powder formulation.And on the chamber that contains powder formulation (as a kind of antibiotics), form the dismounting mouth, then got rid of this danger.

Below with reference to Figure 13, the another kind of method for optimizing of manufacturing container of the present invention is described (a)～(j).

As at Figure 13, (a) shown in, in being similar to a kind of double-plastic 3 shown in Figure 3, form the hole 2a of a dismounting mouthful.

See Figure 13 (b) then, 2a aligns with the hole, adopts heated sealant will dismantle mouth 2 and is connected on the skin (being the PE layer).Then, as Figure 13, (c) shown in, along a straight line thin film 3 is converted into two foldings by dismounting mouthfuls 2.

Next see Figure 13, (d), under about 170～200 ℃ temperature, along the peripheral part except that the opening 35,36 of powder charge thing preparation and powder formulation with two heat seals of thin film 3 together to form a plastic container body 1.Medicine containing opening 35 can be sealed, and only allow medicine containing opening 36 keep us to open.

Under meet personally Figure 13, (e), under about 110 ℃～130 ℃ heat seal temperature, form two parallel weak seal sections at the middle part of container body and

divide

8a, 8b, a slit part 9 is left in the centre.For matching, it is 10 millimeters that weak seal section divides the width of 8b, is 5 millimeters and weak seal section divides the width of 8a.

Next, form the container upper and lower 1A that is divided 8a, 8b to separate by weak seal section, 1B.Then by opening 36 pharmaceutical preparation 11 of in the 1B of container bottom, packing into, after this, with 35,36 sealings of two medicine containing openings, as Figure 13, (f) shown in, next sterilize with autocrave.

Referring to Figure 13, (g), the body after the sterilization from outside dry, is cut opening portion 35 under gnotobasis, opening 35 is reopened, by opening 35 air that cleans is added the inside of container top 1A so that dry and cleaning.

Again referring to Figure 13, (h), under aseptic condition, with a kind of powder formulation 10 by the opening 35 container top 1A that packs into, after this with medicine containing opening 35 sealings.

Referring to Figure 13, (i) adopt as shown in Figure 5 coverlay 5 of two diaphragm arrangement that constitutes by special thin film 6 to surround container top 1A.Preferably, one of two diaphragms are transparent, and another is opaque.

For on the edge that is thermally sealed on container top 1A at thin film 6 time, preparation 10 affected by heat not basically of packing into is provided with an about space of 5 millimeters between sealed contacts 6b that preferred way is the thin film 6 in the 1A of container top and the chamber 1a.For this reason, the contact 1A of container top 1A periphery ₁(seeing Figure 13, (a)), particularly its opposite side portion must have the width greater than 5 millimeters.Consider the sealed width of thin film 6, this width is about 7～10 millimeters usually.

As see that Fig. 4, the following part 6c of coverlay 5 are sealed in two weak seal sections and divide 8a, on the position of the slit part 9 between the 8b.When the thin film 6 that adopts when being transparent, seal temperature is about 150～170 ℃, and maybe when the thin film of employing was a kind of opaque aluminizer, seal temperature was about 130～150 ℃.

As referring to Figure 13, (i), be located at around the 1A of container top coverlay 5 at the beginning the one side be part we open, as representing with 40., after this opening 40 is sealed the space 7 between a kind of noble gas or dry gas injection coverlay 5 and the container top 1A by opening 40.Figure 13, (j) then expression obtained of the present inventionly have containers that two chambeies and two weak seal sections divide.For the embodiment of front,, the heat seal temperature that forms each contact is provided with an optimum temperature range selectively according to the relevant thin-film material and the sealing intensity of expection.Therefore, the temperature range that provides above is restrictive anything but.

Although with reference to several embodiment the present invention is described above, the present invention is in no way limited to these embodiment, but obviously can implement in various mode in category of the present invention.

Claims

1, a kind of container, have a plurality of tapping bodies that are used for, powder or solid chamber and the separating device that this container is divided into a plurality of chambeies and allows when needed to be communicated with between each chamber, this container is characterised in that: this container comprises a flexible plastic container body that constitutes multi-cavity, one of them chamber surrounds with a coverlay, other chamber does not have coverlay to the periphery that this film has a sealing to form the space of a sealing around this chamber, this coverlay is had the fexible film that stops the gentle body performance of moisture content and is made by a kind of, this separating device is made of at least one weak seal section branch, and this part can be opened with the internal pressure that applies an increase at an easy rate by pressing cavity.

2, container as claimed in claim 1 is characterized in that: be provided with at least two weak seal section branches a gap, and this coverlay has a thermosealed edge between contiguous weak seal section divides.

3, container as claimed in claim 1 is characterized in that: in the enclosed space in the coverlay of this container body a kind of noble gas or dry gas are housed.

4, container as claimed in claim 1 is characterized in that: be placed with a kind of oxidation and/or hygroscopic liquid, powder or solid of being easy in the chamber that is capped.

5, container as claimed in claim 1 is characterized in that: these one or more weak seal section branches are that the interior surface opposing direct heat by the flexible plastic film that will form this container body is sealed and forms.

6, container as claimed in claim 1, it is characterized in that: these one or more weak seal section branches are to adopt a kind of insertion film that is clipped between the interior surface opposing, and the flexible resilient thin film interior surface opposing heat seal that constitutes this container body is formed together.

7, container as claimed in claim 1, it is characterized in that: this container body is made of a kind of flexible plastic film, comprising a skin that constitutes by straight-chain low density polyethylene, an intermediate layer that constitutes by straight-chain low density polyethylene and the elastomeric resin compound of ethylene/alpha-olefin, and an internal layer that constitutes by straight-chain low density polyethylene and polyacrylic resin compound.

8, container as claimed in claim 1 is characterized in that: this coverlay comprises that one deck is coated with silicone resin film.

9, container as claimed in claim 1, it is characterized in that: this coverlay comprises a skin that is made of the polyethylene terephthalate thin film of biaxial orientation, one by being coated with the intermediate layer that the silicon polyvinyl alcohol film constitutes, and an internal layer that is made of low density polyethylene (LDPE).

10, container as claimed in claim 1 is characterized in that: this coverlay has an outer surface that is made of the thin film that is surrounded by aluminium flake.

11, container as claimed in claim 4 is characterized in that: this easy oxidation and/or hygroscopic material are a kind of antibiotics.