CN1251075A - Multi-compartment rehydrating container - Google Patents

Abstract

There is disclosed a new self-rehydrating container for the production of solutions or suspensions substantially free or undesirable micro-organisms. The container is divided into at least two compartments by at least a non-permanent seal bonding the opposite walls of said container, the walls of the container surrounding at least a first compartment being watertight, the walls of the container surrounding at least one portion of at least a second compartment being semi-permeable, a water soluble or suspendible product or a concentrated solution or suspension thereof being retained in said second compartment and a water soluble or suspendible product, a drug, a nutritional suspension or powder to be put into solution or suspension is retained in said first compartment. This new self-rehydrating container allows the production of pure solutions of very low molecular weight solutes, of accurately dosed solutions, prevents the oxidation and hydrolysis of the material to be rehydrated and prevents the contamination of the rehydrated material by eventual residual bacteria.

Description

Multi-compartment rehydrating container

Invention field

The present invention relates to a kind of new rehydration container, it has the chamber of at least two isolation, and solute, medicine, insoluble matter or their compound are housed in the chamber.The invention still further relates to the method for preparing ORS or suspending fluid with this container.

Background of the present invention and prior art

Know that cellulose membrane is a kind of semi-permeable high-strength membrane of relatively inertia, method that can be by for example infiltration comes the compound separation of different molecular weight.According to EP360,612 or USP4,920,105, these films as film, are used for the production of self-rehydrating container by effectively, and in container, this film constitutes the part of container wall at least, and wherein osmotically active solute is kept in the container.When this container was put into water, infiltration took place, and was full of the water that has purified through membrane filtration in the container.

In this manual, osmotically active solute is meant and can keeps water miscible basically solute or its concentrated solution that permeates by semipermeable membrane.

Now, also might produce a kind of container, the film that this container contains comprises a high-intensity thick-layer, the aperture of this layer is relative with hole number big, support as a relative thin layer, so that, will reduce to minimum to the unfavorable dialysis influence of infiltration, as what in our common pending application application, disclosed by reducing the molecular cut off (molecular weight cut-off) of whole film.Although this multilayer film has been obtained great advance, the dialysis phenomenon still exists, and the material that mol wt is very low still can pass through film.

Yet the component that claimed mol wt is very low (for example sodium chloride and muriate of potash, mineral matter in the milk powder or low-molecular-weight water soluble vitamin) in some applications.

In other is used, for example oral rehydration solution (ORS), medical solution or drug suspension or solution, final solute concentration must be a clock like precision, therefore the loss that causes by dialysis can not be accepted.Because the degree of dialysis depends on volume of contact time, temperature, contacting with fluid or the like, can not predict accurately that to offset the influence of dialysis be not a kind of practicable terms of settlement so use excessive a certain amount of solute.

In addition, in the F﹠B product or vitamin in the medical solution and mineral matter, need the protection of opposing oxidation and/or hydrolytic action.Therefore, it is essential being stored in these unsettled materials in the independently pouch that can open easily before use, and is foundation of the present invention.

Another problem is present in such fact: the solution that is used for production nutrition solute when the container that has semipermeable membrane for example when milk power solution or fruit juice preparation, may contain the residual bacterium that is in dormant state usually in the dried foodstuff.When container was put into about 30 ℃ water, for example at tropical zone, the solution after the rehydration directly used after preparation, serious problem of bacteria can not take place.But if container is retained in after preparation in 30 ℃ the water, the contaminative bacterium can breed, and health is caused serious threat.Therefore, in the independently pouch that these preparation stored that may contain milk powder, dry food or the fruit juice of residual bacterium or other dry form have just been opened in the time can having opened and only be full of when container the water that purifies easily for before use, will be interesting.

From EP360,612 learn the application of the container that has additional water tightness bag, and water-soluble solute, other solute, liquid, medicine, insoluble matter or the like are housed in the described bag.In case when it was shifted out from outside water, material was released in the purifying waste water of obtaining in the container in the bag.EP360, Fig. 3 of 612 have disclosed a kind of two containers that can split inner bag cruelly that water-soluble solute is housed that have.This is open not to make any other embodiment of the container that has additional bag become possibility, and it does not advise any such embodiment yet.

A kind of like this bag efficient floating in container is not very high.Its production needs many replenish step, and it is not easy to use.End user's inner bag that must break in water-filled container avoids damaging container itself simultaneously.

Therefore highly significant provide a kind of like this self-rehydrating container, this container comprises the osmotically active chamber and at least one independently is equipped with the water tightness chamber of solute, liquid, medicine, nutriment, insoluble matter or the like (normally water-soluble or suspension product), this container is easy to produce, and uses especially easily.

In this manual, the osmotically active chamber is meant that it is semipermeable materials that this chamber has a part of wall at least, and when osmotically active solute is kept in this chamber and when this chamber is placed in the water, infiltration can take place like this.

Description of the invention

Therefore, first purpose of the present invention provides a kind of self-rehydrating container, is used for the production of oral rehydration solution, nutritive solution or suspending fluid, medical solution (being exactly to be used for oral, local application, peritonaeum medication).Another object of the present invention provides a kind of self-rehydrating container, its feasible solution that can prepare exact dose.Another object of the present invention provides a kind of self-rehydrating container in addition, is used to contain the preparation of the solution of Unstable Substance or low molecular weight substance, in these solution basically not from the germ of outside water.A further object of the present invention is that a kind of self-rehydrating container also is provided, and is used for not having basically the nutritive solution of the undesirable germ that has grown at container or the production of suspending fluid.

Another object of the present invention provides a kind of self-rehydrating container, and it can realize these requirements, but it also is easy to use and produce.

The present inventor has been found that all these requirements can realize by the self-rehydrating container with certain architectural feature.

Here it is, and why the present invention at first relates to a kind of self-rehydrating container, be used to be substantially devoid of the production of solution or the suspending fluid of undesirable germ, it is characterized in that the impermanency sealing that connects the relative wall of described container by at least one is divided at least two chambers with said container, around the container wall of first chamber at least is water tightness, container wall around at least a portion of at least the second chamber is semi-permeable, osmotically active solute is kept in said second chamber, desires to put into the solute of solution or suspending fluid, medicine, nutrition suspending fluid or powder are kept in said first water tightness chamber.

In this manual, be meant may be because sealing and fixing inefficacy or peripheral operation or be subjected to the influence of hydraulic pressure and peel off or destroyed sealing for impermanency sealing.

In a special embodiment, container is made of the rectangular sheet of semipermeable materials, and this sheet material self is folded to form pipe, the lap of the bonding said pipe of water repellant longitudinal sealing, said pipe is crushed, with the top and the bottom end of sealing mode sealed tube.The semipermeable materials of component film can comprise in cellulose, regenerated cellulose (cellophane, cuprammonium cellulose ...), benzoylated cellulose and the collagen and selecting from many kinds of materials.

Preferable material is a regenerated cellulose.When using material of regenerated cellulose, this film can be produced by one or more known method of production, for example xanthate, cuprammonium, carbamate or organic solute (for example NMMO) method.

As what disclosed in our common pending application, this film can be as the supporting layer of second thin layer.

The second layer can be made up of the poly-mer (for example starch, protein etc.) of the natural generation of cellulose derivative (for example ether, ester, nitrocellulose or the like), synthetic organic polymer (for example polyacrylates, polyvinyl acetate ester copolymer, polyurethane, aliphatic polyamide for example nylon 6, nylon 6.6, nylon 4.6 and similar material), modification or non-modified.

The preferred second layer is made up of the skim hydrophilic polyurethane, and for example routine is used for covering fabric with waterproof but those of the permeable protective coat of water vapour.

Preferably, the whole thickness of film is the 20-50 micron.

For forming the sealing of in-to-in impermanency, be divided into two chambers with inner space with container, the sheet material of semipermeable materials advantageously has an adhesive material, and it is that direction with the tubular axis of the pipe that forms perpendicular to desire is applied in it.Therefore, when pipe was crushed, the relative wall of container had a jointing material aligned with each other, and when pressurization, no matter heated, and had produced sealing between the relative wall of container.

Being suitable as adhesion substance is hot sealable binding compositions with the suitable material that forms the relative wall that seals bonding container, for example polyvinylidene chloride, polyethylene, thermoplastic polyurethane, ethylene vinyl acetate copolymer, acrylic resin and similarly material, a kind of separately or their compound.Additive for example wax also can add in these composites.

The sealable binding compositions of cold conditions rubber for example natural or modification, poly-chloroprene rubber and similar material also are fit to.

Observe, when with the direction that is parallel to bonding wall it being applied hydraulic pressure, such sealing is destroyed easily.Therefore simply by container is turned around, so as to make the chamber (osmotically active chamber just) that is filled with water be positioned at the water tightness chamber above, only need kind sealing in several seconds just destroyed, make that the water after purifying enters the water tightness chamber.

According to the present embodiment the longitudinal sealing of duct occlusion also can advantageously be had some specific features.

In order to keep this leak free globality, the geometric configuration that seals self is very important.Sealing can be born quite high hydraulic pressure and do not opened really to be needed.The inventor has observed the sealing of semipermeable materials sheet material between two different pieces on the lap position and can bear quite high hydraulic pressure and do not open.Having observed that lap seal tolerates high hydraulic pressure and do not open is because bonding plane of shear is no longer consistent with hydraulic pressure.Lap seal according to this embodiment is a kind of like this sealing, wherein at adhesion area, the relative wall of two kinds of semipermeable materials is with parallel relation location, film end directed in opposite directions separately, together bonded to each other by bonding coat, hydraulic pressure is no longer consistent with the bonding plane of shear of bonding coat like this.

Can be hot sealable binding compositions with the suitable material that forms longitudinal sealing as jointing material, for example polyvinylidene chloride, polyethylene, thermoplastic polyurethane, ethylene vinyl acetate copolymer, acrylic resin and similarly material, a kind of separately or their compound.Additive for example wax also can add in these composites.

The sealable binding compositions of cold conditions rubber for example natural or modification, poly-chloroprene rubber and similar material also are fit to.

This lap seal also can be used as the osed top mode in the top and the bottom of container.

At one more particularly in the embodiment, in the sealing mode at the top of container and bottom end place by being that water-proff packing between the relative wall of container is formed.

Double folding sealing according to the present embodiment is a kind of compound seal, wherein in bonding zone, two blocks of semipermeability sheet materials are with parallel relation location, the terminal of film is pointed to equidirectional separately, in bonding zone, the end of the sheet material of parallel placement is folded back, and the outer surface part of semipermeable materials sheet material faces toward mutually like this.Said end is bonded together mutually like this by adhesives, so that the hydraulic pressure that may act on the longitudinal sealing is consistent with the bonding plane of shear of adhesive coatings.The adhesive bonding property coating is bonded together two outer surface part of sheet material, also keeps not opening even be in hydraulic pressure huge in the container.

Can be hot sealable binding compositions as the suitable material of top and bottom leak free jointing material, for example polyvinylidene chloride, polyethylene, thermoplastic polyurethane, ethylene vinyl acetate copolymer, acrylic resin and similarly material, a kind of separately or their compound.Additive for example wax also can add in these composites.

The sealable binding compositions of cold conditions rubber for example natural or modification, poly-chloroprene rubber and similar material also are fit to.

For the wall that makes first chamber becomes water tightness or bubble-tight, it is coated the suitable block water or the composite of gas, for example enter one or two surface of film by solution coating, lamination, extrusion coated or in-situ polymerization.

For this reason, the material that is fit to is: for the wall of water tightness only, being the copolymer of polyvinylchloride and vinyl acetate or maleic acid vinyl esters and similar material, for water tightness and air-tightness wall, is polyvinylidene chloride and similar material.

According to the present invention, the self-rehydrating container can be used in the aqueous system of water-soluble or suspension product that the preparation mol wt is significantly less than the molecular cut off of film.

In this case, low-molecular weight water-soluble or suspension product must be kept in the water tightness chamber, and osmotically active solute (may be same substance) is kept in the osmotically active chamber simultaneously.In case container is moved out of from outside water, the impermanency sealing is destroyed, and final solution or suspension preparation are come out.

The Another application of self-rehydrating container is the preparation of solution of the exact dose of unsettled water-soluble or suspension product.In this case, unsettled water-soluble or suspension product is kept in the water tightness chamber, and osmotically active solute is kept in the osmotically active chamber simultaneously.Also should there be the volume of a mark with the water of definite said container the osmotically active chamber.

In case water level inside has reached this mark, container is shifted out from outside water, and the impermanency sealing is destroyed, finally is produced out by the solution of accurate quantification or suspension.

According to the present invention; a kind of self-rehydrating container also can be applied to protect product, and for example vitamin, fat or medicine are avoided the influence of oxidation or hydrolytic action; because ought in the osmotically active chamber, prepare by aseptic basically water; after (destruction) is peeled off in the impermanency sealing; they only before use with water (and air, if the chamber also is bubble-tight words) contact.

In Another application, the ORS of food-grade or suspending fluid can prepare according to container of the present invention by using, and its storage life can prolong.In fact, the dried foodstuff pruinescence is stored in the water tightness chamber, mixes with water in case only be produced out before use at sterilized water.Because remove water, the contaminative bacterium of food dry powder if any, will no longer breed.In case the solution with the container preparation is ready to, and just can directly use or refrigerate.

A typical application of later-model band water tightness and anti-oxidation chamber self-rehydrating container is that protection dialysis and oxidation takes place easily and may contain bacterium or the baby formula milk of microbial spores (their can be bred along with the time so that reach hazard level when mixing with water) and the component that milk is used in the high-energy treatment of dormancy.Carbohydrate is as the water-soluble osmotically active solute in the osmotically active chamber.

Another typical application according to new type auto rehydration container of the present invention is the preparation of oral rehydration solution.In this used, composite can distribute in two chambers that enter according to container of the present invention by following mode: 38 grams per liter sucrose and 2.9 grams per liter trisodium citrates were in the osmotically active chamber, and 3.5 grams per liter sodium chloride and 1.5 grams per liter muriate of potash are in the water tightness chamber.

Sodium chloride and potassium chloride mixture are arranged in the water tightness chamber like this, in another chamber, have the container of osmotically active sucrose/citrate mixt to be dipped in the water, and " can use " mark towards.Infiltration is passed through in the osmotically active chamber, and is filled the mark position that reaches " can use " by water, and the water tightness chamber floats on the surface simultaneously.The water in case substitute the bad for the good shifts out bag from outside water gently.

Container is turned around, and the impermanency sealing is opened gently.Salinity mixes with water, obtains oral rehydration solution.Then, people can or cut top section, feed anh human or animal with spoon or cup, perhaps rip the sealing at top, and this container is put into a suitable containers that provides support, and the inside face by exposing film is for drinking.

The explanation embodiments of the invention are as follows: the specially designed material 1.1.2.2.1 of preparation 1.1 film 1.1.1 regenerated cellulose film 1.1.2 complex film 1.1.2.1 commercial materials 1.1.2.1.1 nitrocellulose grade A500 (BAYER AG) 1.1.2.1.2 nitrocellulose DML30/50 (ICI) 1.1.2.2. of embodiment 1 container is about 85.50 molal weights 2000 carbowax (PEG2000 (INSPEC), 72.80 molal weight is about 2000 polytetramethylene glycol (TERATHANE 2000 (DUPONT)), 21.24 gram ethylene glycol and 105.46 grams 1,1 '-di-2-ethylhexylphosphine oxide (4-isocyanato-benzene) band mechanical agitator of solution importing in 420 gram Dimethyl fomamides and 65 gram butanone liquid, heat indicator, air condenser, in the flask of 2 liter of four neck round bottom of nitrogen inlet and tap funnel.Compound is 90 ℃ of heating stirrings simultaneously down, and 0.15 gram 2 ethyl hexanoic acid tin (DABCO T9 (AIR PRODUCTS)) is imported into as catalyst.Reaction mixture remains on 90 ℃ and assigned 2 hours, then cooling.

120 gram butanone are imported in the reactor then.1.1.2.2.2 with the carbowax (PEG 600 (HOECHST)) of 133.02 molal weights about 600 and 79.00 grams 1,1 '-solution of di-2-ethylhexylphosphine oxide (4-isocyanato-cyclohexane) in 342.00 gram toluene imports in the flask of 2 liter of four neck round bottom of band mechanical agitator, heat indicator, air condenser, nitrogen inlet and a tap funnel.Compound is 90 ℃ of heating stirrings simultaneously down, and 25 milligrams of dibutyl tin laurates (DABCO T12 (AIR PRODUCTS)) are imported into as catalyst.Reaction mixture remains on 90 ℃ and assigned 6 hours, then cooling.

13.68 gram IPDs are imported in the flask of 2 liter of four neck round bottom of second band mechanical agitator, heat indicator, air condenser, nitrogen inlet and tap funnel at the solution of 350.00 grams in the isopropyl alcohols.

Content in first flask is cooled to room temperature, then it is slowly joined in alcohol/amine blends (second flask).The chain expansion was finished after about 3 hours.

44.2 grams or fumed silica (TS100 DEGUSA) and 50 are restrained toluene to join in the compound.1.1.2.2.3 with 114.40 molal weights be about 400 carbowax (PEG400 (HOESCHT)), 20.60 molal weights be about 1000 polytetramethylene glycol (TERATHANE 1000 (DUPONT)) and 106.80 grams 1,1 '-solution of di-2-ethylhexylphosphine oxide (4-isocyanato-cyclohexane) in 342.00 gram toluene imports in the flask of 2 liter of four neck round bottom of band mechanical agitator, heat indicator, air condenser, nitrogen inlet and a tap funnel.The remainder of method is the same with embodiment 1.2.2, but isopropyl alcohol replaces with ethanol, and IPD replaces with the compounds of the aqueous system (15% percentage by weight) of 11.35 gram IPDs and 7.12 gram hydrazines, and toluene replaces with ethyl acetate.1.2 sealing

Polyvinylidene chloride (from the VICLAN VR 545 of ZENECA)

Polyvinylidene chloride (from the IXAN PNE 613 of SOLVAY) 1.3 water tightness coatings

Polyvinylidene chloride 1.4 container 1.4.0 prepare without any the leak free container that the inner space is divided into two chambers to be used for contrast.1.4.1 according to band impermanency leak free container of the present invention.The application 2.1 of embodiment 2 self-rehydrating containers comprises that the solid composite of sucrose (27 gram), trisodium citrate (1.7 gram), sodium chloride (14 gram) and muriate of potash (6 gram) is stored in unique chamber of the container for preparing according to 1.4.0, puts into a container that contains 4 premium on currency with container.After about 9.5 hours, 496.4 ml solns generate, and wherein contain to be equivalent to every liter 42 gram sucrose, 3 gram trisodium citrates, 3.5 gram sodium chloride and 1.5 gram muriate of potash.

About 20% sucrose and trisodium citrate are lost effectively by dialysis.About 88% sodium chloride and muriate of potash are also lost by dialysis.Be placed on by in the osmotically active chamber in the container of 1.4.1 preparation 2.2 contain the solid composite of sucrose (27 gram) and trisodium citrate (1.7 gram), sodium chloride (1.75 gram) and muriate of potash (0.75 gram) are kept in the water tightness chamber.Container is placed in 4 premium on currency.9.5 after hour, generate 498 ml solns, wherein contain be equivalent to every liter 42 the gram sucrose and 3 the gram trisodium citrates.It is not moving that the water tightness chamber keeps, and floats on the surface.Container is turned around, and in less than 1 minute, water enters the water tightness chamber.Solution is mixed, and causing concentration is every liter of solution 42 gram sucrose, 3 gram trisodium citrates, 3.5 gram sodium chloride and 1.5 gram muriate of potash.

About 20% sucrose and trisodium citrate are lost effectively, but sodium chloride and muriate of potash are not all lost.Last solution component satisfies the code requirement of the World Health Organigation to oral rehydration solution.2.3 use the container of 1.4.0 preparation, might and put it in 4 liters of outside water by the milk powder of in container, packing into (38 gram), take rehydration high-energy treatment milk.After about 8 hours, 200 gram milk liquid generate.

But, having been found that potassium iodide, muriate of potash and the magnesium chloride of dialysing and reaching balance have the loss that surpasses 90% weight, zinc acetate and citric acid tri potassium carry out dialysis respectively 30% and 10% loss take place.In addition, water soluble vitamin for example all might dialyse or oxidation by vitamin C, folic acid or the like.

Be present in treatment and also be easier to oxidation with the fat in the milk.

The initial bacterium OAS (TVC) of the milk that generates is low, but in 1～2 hour, TVC rises to the human unacceptable degree of using.2.4 with the container of top 1.4.1 preparation, sucrose (10 gram) is only contained in the osmotically active chamber.Contain dry defatted milk, fat, vitamin and mineral matter (32 gram) in the water tightness chamber.Container is placed in 4 premium on currency, and after about 8 hours, the aseptic sucrose solution of 200 grams is produced out.About 20% sucrose is dialysed.At this moment, container is turned around, in 1 minute, water enters the water tightness chamber.Milk is mixed fully.By this technology, all vitamins and mineral matter are saved, and the oxygenation efficiency of fat or vitamin is low, and fresh milk is aseptic, and storage life prolongs greatly.

Claims (14)

1. be used to be substantially free of the self-rehydrating container of the production of the solution of undesirable germ or suspending fluid, it is characterized in that connecting the impermanency sealing of the relative wall of described container by at least one, container is divided at least two chambers, around the container wall of first chamber at least is water tightness, container wall around at least a portion of at least the second chamber is semi-permeable, osmotically active solute is kept in said second chamber, desires to put into the solute of solution or suspending fluid, medicine, nutrition suspending fluid or powder are kept in said first water tightness chamber.

2. according to the self-rehydrating container of claim 1; the semipermeable materials that it is characterized in that forming at least a portion of at least one chamber is to choose from one group of material being made up of cellulose, regenerated cellulose, benzoylated cellulose and collagen, and said material has coating or do not have coating.

3. according to the self-rehydrating container of claim 2, it is characterized in that semipermeable materials contains second thin layer that first supporting layer of being made up of cellulose, regenerated cellulose, benzoylated cellulose or collagen and the material that chooses are formed from one group of material being made of poly-mer cellulose derivative, synthetic organic polymer and modification or unmodified natural generation.

4. according to the self-rehydrating container of claim 3, it is characterized in that second thin layer be made up of the hydrophilic polyurethane of skim.

5. according to each the self-rehydrating container among the claim 1-4, it is characterized in that the water tightness chamber preserved the water-soluble solute that molecular cut off is lower than the molecular cut off of said semipermeable materials.

6. according to each the self-rehydrating container among the claim 1-5, it is characterized in that the osmotically active chamber has the feasible volume that can determine water in the said chamber of mark, the composite of the water-soluble solute of accurate metering has been preserved in the water tightness chamber, like this when the composition dissolves of said accurate metering in the water of the osmotically active chamber being filled the volume that reaches an appointment time, has just been obtained the solution of accurate metering.

7. according to each the self-rehydrating container among the claim 1-6, it is characterized in that the impermanency sealing is made up of polyvinylidene chloride.

8. according to each the self-rehydrating container among the claim 1-7, it is characterized in that the wall of water tightness chamber further has the characteristic of barrier gas, preferably is essentially air-tightness.

9. according to the self-rehydrating container of claim 8, it is characterized in that coating is made up of polyvinylidene chloride.

10. according to each the self-rehydrating container among the claim 1-9, it is characterized in that the water tightness chamber preserves the dried foodstuff product.

11., it is characterized in that water tightness preservation baby milk powder or high-energy treatment milk powder according to the self-rehydrating container of claim 10.

12. be substantially free of undesirable germ, at least a water-soluble or the solution of suspension product or the preparation method of suspending fluid, it is characterized in that it may further comprise the steps:

A) according to comprising said at least a low-molecular weight water-soluble or suspension product in each the self-rehydrating container among the claim 1-11;

B) osmotically active solute is incorporated in the osmotically active chamber of said container;

C) said container is immersed in the water, allow its purifying waste water in the osmotically active chamber under water reach enough degree;

D) open the impermanency sealing;

E) allow the water tightness chamber by the filling of purifying waste water from the osmotically active chamber;

F) randomly, allow be kept at first in the water tightness chamber water-soluble or suspension product dissolving or

Mixing is until obtaining solution or suspending fluid.

13. dairy products according to the preparation of the method for claim 12.

14. oral rehydration solution according to the preparation of the method for claim 12.