KR100810388B1 - Medical Liquid Container - Google Patents

Abstract

In order to provide a medical liquid container without fear of forgetting to open the dividing wall and to reduce the production cost by realizing simple and easy sterilization of the liquid medicine bag, the present invention provides a plurality of medical liquid containers communicatively divided. A medical liquid container having a seal and an effluent storage room having a liquid drug outlet formed therein, wherein the medical liquid container comprises a liquid-tight partition portion for liquid-tightly separating the liquid drug storage chambers from each other, and the liquid medicine container. A medical liquid container is provided that includes a non-liquid seal dividing portion for non-liquid seal separation between at least one of the seals and the effluent reservoir.

Medical liquid container, liquid-tight partition, non-liquid partition, medical liquid storage room, effluent storage room

Description

Medical Liquid Container

The present invention relates to a medical liquid container for containing a liquid medicine, and more particularly to a medical liquid container having a plurality of liquid chambers for storing a liquid medicine.

Cross Reference to Related Application

This application claims 35 U.S.C. of US Provisional Application No. 60 / 580,908, filed June 21, 2004. Claims benefit under section 119 (e) and claim priority over Japanese Patent Application No. 2004-164770, filed June 2, 2004 and US Provisional Application No. 60 / 580,908, filed June 21, 2004 The contents of which are incorporated herein by reference.

Medical liquids in which two or more liquid medicines are individually stored in a divided liquid medicine storage compartment, and when used, open a partition wall separating the liquid medicine storage compartments to mix the liquid medicines for use in drip infusion or the like. The container is known. Such a medical device for storing a plurality of liquid medicines in a liquid medicine storage chamber divided by a partition wall, and opening the partition wall at the time of use, reduces trial and error, prevents contamination by bacteria during liquid medicine production, and It is widely used due to advantageous advantages such as increased efficiency in the manufacture of liquid pharmaceuticals. However, in the real medical field, the problem of forgetting and not opening the dividing wall causes administration of incomplete liquid medication to the patient. For the purpose of avoiding such a problem, a medical liquid container having a plurality of medical liquid storage chambers, in which a discharge port for a liquid medicine is formed therein for failure-free mixing of two or more liquid medicines in use. Medical liquid containers having a discharge reserve chamber are known.

For example, JP-A-9-324798 (the term "JP-A" as used herein means "Japanese Unexamined Patent Application before Examination") includes a plurality of liquid drug storage chambers and an effluent storage chamber. A medical liquid container, in which a dividing wall separating a plurality of liquid pharmaceutical compartments from each other opens before the dividing wall separating the liquid pharmaceutical compartment and the effluent reservoir, so that in use two or more liquid medications are mixed without failure. Is described.

Similarly in JP-A-2002-136570, pressing the liquid medicine compartment opens the partition wall separating the liquid medicine compartments from each other before the partition wall separating the liquid medicine compartment and the effluent compartment, causing two or more liquid medications to fail. It is described for a medical liquid container which is mixed without.

Liquid medicine bags containing liquid medicine in the liquid medicine compartment of the medical liquid container are heat sterilized by hot steam to ensure aseptic status in the liquid medicine compartment. When sterilizing the medical liquid containers disclosed in JP-A-9-324798 and JP-A-2002-136570, in which the liquid medicine is filled in the liquid medicine storage chamber, moisture or the like is contained in the effluent storage chamber. Since it is not present, the sterilization may be insufficient even after the heat sterilization treatment performed under the same conditions as for the liquid drug storage chamber. In order to overcome this problem, the effluent reservoir must be sterilized by radiation or chemical treatment separately from the heat sterilization of the liquid pharmaceutical compartment, which causes a problem that the manufacturing process of the liquid pharmaceutical bag is complicated and the production cost is increased. .

The present invention has been made under such a situation, and an object of the present invention is to provide a medical liquid container which can reduce production costs by realizing simple and easy sterilization of a liquid medicine bag without fear of forgetting to open the partition wall. .

Summary of the Invention

In order to achieve the above object, the present invention provides a medical liquid container having a plurality of liquid drug storage chambers commuunicatably divided, and an effluent storage chamber in which a liquid drug outlet is formed. A medical liquid comprising a liquid-tight portion for separating the seals from one another and a non-liquid-tight portion for separating non-liquidtightly between at least one of the liquid pharmaceutical compartments and the effluent reservoir. Provide the container.

The liquid-tight partition portion may be sufficient if a rise in pressure in the liquid drug storage chamber results in a communicated state. The non-liquid-split portion may also utilize a pressure rise in the liquid medicine compartment to cause communication. In addition, the liquid-tight portion and the non-liquid portion may both be in communication by utilizing the pressure rise in the liquid medicine compartment. The non-liquid dividing portion is sufficient unless the liquid-liquid dividing portion is not in communication with the pressure rise in the liquid medicine storage chamber in which the liquid-liquid dividing portion begins to communicate. The liquid tightly divided portion may comprise a peelable seal.

The non-liquid-split portion is a peelable seal, a membrane which is rupturable by a rise in pressure in the liquid pharmaceutical compartment, or a blocking plug that can block or open the communication opening, each of a small amount of liquid medication, or It may have a pore hole that allows water in the liquid medicament to permeate. The non-liquid seal divided part may also include a seal obtained by interposing a liquid-permeable and / or moisture-permeable material between the peelable sealing materials.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is an external perspective view showing a liquid medicine bag filled with a medical therapeutic liquid medicine in the medical liquid container of the present invention.

2A to 2C are explanatory views showing the use process of the liquid medicine bag shown in FIG.

It is explanatory drawing for demonstrating the operation of the medical liquid container of this invention.

4 is an explanatory view showing still another embodiment of the medical liquid container of the present invention.

5 is an explanatory view showing still another embodiment of the medical liquid container of the present invention.

6A to 6C are explanatory views showing still another embodiment of the medical liquid container of the present invention.

7 is an explanatory view showing still another embodiment of the medical liquid container of the present invention.

Embodiments of the present invention are described below with reference to the drawings. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is an external perspective view showing an example of a liquid medicine bag in which a liquid medicine for medical treatment is filled in a medical liquid container of the present invention. The liquid medicine bag 10 is, for example, two types of liquid medicines, namely, a first liquid medicine 11 and a second liquid medicine 12, and a medical liquid for separately storing these liquid medicines 11 and 12. Container 13.

The medical liquid container 13 is made of a synthetic resin film, and the peripheral edge portion thereof is sealed to prevent peeling. Resin used for a synthetic resin film will not be restrict | limited especially if it is resin used for the field of medical containers. Specific examples of the resin include polyolefin resins, polyamide resins, polyester resins, (meth) acrylic resins, vinyl chloride resins, vinylidene chloride resins, polyethersulfones and ethylene-vinyl alcohol copolymers. Among these, polyolefin resin is preferable because it is inexpensive and excellent in transparency, flexibility, and hygiene.

Examples of polyolefin resins include polyethylene resins such as high density polyethylene, medium density polyethylene, high pressure low density polyethylene, linear low density polyethylene, and ethylene-vinyl acetate copolymers, olefin elastomers such as ethylene-α-olefin random copolymers, polypropylene, ethylene Mono- or multilayer films comprising polypropylene-based resins such as -propylene random copolymers and α-olefin-propylene random copolymers, cyclic polyolefin resins, and mixtures of these resins. Such resin may be partially crosslinked for the purpose of improving heat resistance and the like. Such a synthetic resin film may have a thickness of about 50 to 1,000 μm, preferably about 100 to 500 μm.

The medical liquid container 13 is divided into a first liquid medicine storage chamber 15, a second liquid medicine storage chamber 16, and an effluent storage chamber 17. The first liquid medicine 11 and the second liquid medicine 12 are accommodated in the first liquid medicine storage chamber 15 and the second liquid medicine storage chamber 16, respectively. These 1st liquid chemical | medical agent storage chamber 15 and the 2nd liquid chemical | medical agent storage chamber 16 are isolate | separated by the liquidtight seal 18 which is the peelable liquid-tight part which allows communication.

The liquid-tight sealing part 18 presses the 1st liquid chemical | medical agent storage chamber 15 or the 2nd liquid chemical | medical agent storage chamber 16, and the inside of the 1st liquid chemical | medical agent storage chamber 15 or the 2nd liquid chemical | medical agent storage chamber 16 is carried out. It peels by raising a pressure, and as a result, the 1st liquid chemical | medical agent storage chamber 15 and the 2nd liquid chemical | medical agent storage chamber 16 are integrated. When the liquid-tight sealing part 18 is peeled off in this way, the 1st liquid chemical | medical agent 11 and the 2nd liquid chemical | medical agent 11 respectively accommodated in the 1st liquid chemical | medical agent storage chamber 15 and the 2nd liquid chemical | medical agent storage chamber 16 ( 12) is mixed.

In the example of the method for forming the liquid-tight seal 18, a synthetic resin film having a layer containing a composition of a resin having a different melting point or miscibility, such as a mixture of polyethylene and polypropylene, is formed on the medical liquid container 13 A method used for the inner surface of the resin) and sealed at a temperature lower than the melting point of the high melting point resin. In another preferred example, a method of performing heat-sealing at low temperatures and weak adhesion in a semi-melt-bonded state, a method of using a flexible material pre-crosslinked with an electron beam to the portion where the liquid-tight seal 18 is formed A method of using a seal bar capable of producing a strongly sealed portion at a specific area ratio, and a method of interposing an easily peelable resin tape between two sheets of flexible material.

The second liquid drug storage chamber 16 and the effluent reservoir 17 are separated by a non-liquid seal 19 which is a non-liquid dividing portion. The non-liquid seal 19 is partially formed with pores 19a penetrating between the second liquid drug storage chamber 16 and the effluent storage chamber 17. One or multiple pore (s) 19a may be formed. In the example shown, the unsealed portion forms the pores 19a in the manufacture of the non-liquid seal 19. When the 1st liquid chemical | medical agent storage chamber 15 and the 2nd liquid chemical | medical agent storage chamber 16 are in a non-pressurized state, this pore 19a is made into the 2nd liquid chemical | medical agent accommodated in the 2nd liquid chemical | medical agent storage chamber 16 ( 12) or leaks a small amount of water in the second liquid medicament and introduces it into the effluent reservoir 17.

Alternatively, the pores 19a serve to pass moisture in the liquid medicament 12 and to introduce it into the effluent reservoir 17 in vapor or liquid state during high pressure steam sterilization. Thus, the pores may not only be simply formed, but may also be filled with a liquid-permeable or moisture-permeable material capable of passing the second liquid medicament 12 or moisture in the vapor or liquid state into the effluent reservoir 17.

When the first liquid medicine compartment 15 or the second liquid medicine compartment 16 is pressed, the liquid tight seal 18 is lowered by a pressure rise lower than the pressure rise for peeling the non-liquid tight seal 19. It peels and the 1st liquid chemical | medical agent storage chamber 15 communicates with the 2nd liquid chemical | medical agent storage chamber 16. As shown in FIG. Further pressing of the chamber resulting from the communication between the first liquid drug storage chamber 15 and the second liquid drug chamber causes the non-liquid seal 19 to be peeled off, thereby allowing communication therethrough. In order to implement this operation, the non-liquid seal 19 is formed so as not to allow communication under an internal pressure at which the liquid seal 18 is peeled off and starts communication.

An outlet 21 is formed in the outflow storage chamber 17. The outlet 21 is an outlet through which the mixed liquid medicine generated by mixing the first liquid medicine 11 and the second liquid medicine 12 exits, and the mixed liquid medicine from the medical liquid container 13 like the adapter or the needle. Special outflow equipment for withdrawing is connected to the outlet. The outlet is sometimes used as an inlet for mixing and injecting another liquid medicament into the mixed liquid medicament.

When using the liquid chemical | medical agent bag 10 which has the structure mentioned above as shown in FIG. 2A, the 1st liquid chemical | medical agent storage chamber 15 or the 2nd liquid chemical | medical agent storage chamber 16 is pressed in the arrow P direction, The pressure in the 1st liquid chemical | medical agent storage chamber 15 or the 2nd liquid chemical | medical agent storage chamber 16 is raised. As a result, the peelable liquid-tight seal 18 is first peeled off by a lower pressure rise than the pressure rise that peels the non-liquid-sealed seal 19, and the first liquid medicine storage chamber 15 and the second liquid medicine By incorporating the storage chamber 16, as shown in FIG. 2B, a mixed liquid medicine 23 is obtained. Further pressing of the liquid medicine bag 10 causes the non-liquid seal 19 to be peeled off, and the mixed liquid medicine 23 flows into the effluent storage chamber 17 so that the mixed liquid medicine 23 It can exit from the outlet 21 (see FIG. 2C).

The liquid pharmaceutical encapsulation 10 is configured in this manner, so that the liquid-tight seal 18 is peeled off by lowering the liquid-tight seal 18 by a pressure rise lower than that of the non-liquid-sealed seal 19. It is reliably prevented that the non-liquid seal 19 is first peeled off so that only the second liquid medicament 12 escapes from the outlet 21 before it is peeled off.

Further, even if the liquid drug-flowing equipment is connected to the outlet 21 without peeling off the liquid-tight seal 18, the liquid drug does not flow out in an amount large enough to enable visual confirmation of the liquid drug outflow. In addition, the outflow rate at the start of use of the liquid medicine bag 10 cannot be controlled only by the liquid medicine in the effluent storage chamber 17. Also, after each chamber is in communication with each other to obtain a mixed liquid medicine, when the liquid medicine bag is hung with the outlet 21 facing down at the time of use, even if the lower part near the outlet becomes bulge, the outflow The liquid drug bag 10 in which the water reservoir 17 does not communicate with other chambers is flat because only a very small amount of the liquid drug is contained in the effluent reservoir 17, and the liquid drug bag 10 When suspended with the outlet 21 facing down, it is easy to see that these chambers do not communicate with each other.

As described above, the medical liquid container of the present invention reminds the user of the non-communication, which is easy to forget before actual use, so that only the second liquid medicine 12 comes out of the outlet 21 and the liquid It is certainly prevented that the drug does not substantially spill.

Operation of the medical liquid container of the present invention is described below with reference to FIGS. 1 and 3. The liquid medicinal bag 10 containing the first liquid medicament 11 and the second liquid medicament 12 in the medical liquid container 13 should be sterile at the time of manufacture. The liquid medicine bag 10 is heated with high pressure steam S at, for example, a sterilization temperature. Such high pressure steam sterilization is carried out, for example, by placing the liquid pharmaceutical bag 10 in a pressure vessel and pressurizing it and exposing it to a hot water bath, a hot water shower or steam for a predetermined time.

In this high pressure steam sterilization, as shown in FIG. 3, a small amount of the second liquid medicine 12 housed in the second liquid medicine storage chamber 16 is provided in the non-liquid seal 19. When leaked through and flows into the effluent storage chamber 17 of the liquid chemical | medical agent bag 10, and when the effluent storage chamber 17 is exposed to high pressure steam etc., the water in this small amount of the flowed in the 2nd liquid chemical | medical agent 12a will be partially. Vaporizes and spreads throughout the effluent storage compartment 17, as a result, the pressure therein reaches a saturated water vapor pressure, and the aseptic guarantee level in the effluent reservoir 17 is equal to the sterility guarantee level of the liquid pharmaceutical storage compartment. do. Alternatively, during autoclaving, the liquid or vapor water in the second liquid drug storage chamber 16 flows into the effluent storage chamber 17 through the pores 19a, and the pressure therein reaches a saturated water vapor pressure. As a result, the sterility guarantee level of the effluent storage compartment 17 is equal to the sterility guarantee level of the liquid drug storage compartment.

With known means of not forgetting to open the dividing wall, commonly known liquid pharmaceutical bags must be subjected to an electron beam or chemical sterilization treatment to sterilize the effluent reservoir. However, in the present invention, the non-liquid seal 19 is used for the dividing wall separating the second liquid medicine compartment 16 and the effluent storage compartment 17, and is housed in the second liquid medicine compartment 16. A small amount of water in the second liquid medicament 12 or the second liquid medicament leaks into the effluent storage chamber 17, so that a small amount of the inflow of the second liquid medicament droplet 12a at high pressure steam sterilization causes the effluent storage chamber ( 17) The sterility guarantee level in the same can be made equal to the sterility guarantee level of the liquid pharmaceutical storage chamber, and the radiation treatment or the chemical sterilization treatment for the effluent storage chamber can be omitted. As a result, the simplification of the sterilization step for the medical preparation in the liquid medicine bag, and the reduction of the production cost can be realized, and at the same time, the asepticity of the whole liquid medicine bag with the effluent reservoir can be ensured.

The non-liquid seal 19 is a seal that allows a small amount of liquid to leak between the second liquid drug storage chamber 16 and the effluent reservoir 17. For example, for leak rates in the case of use for medical treatment of a patient, the upper limit is an insufficient leak rate per hour for the mixed liquid medicament to be administered to the patient, and the lower limit is the effluent reservoir 17 and the lower limit. The outlet 21 is filled with the first liquid drug storage chamber 15 when the high pressure steam sterilization is performed under conditions that ensure the sterile state of the first liquid medicine storage chamber 15 or the second liquid medicine storage chamber 16. And a leak rate that provides a sufficient amount of liquid to make an aseptic guarantee level equivalent to the aseptic guarantee level of the second liquid drug storage chamber 16.

This leak rate is for example 0.12 mL / min or less, preferably 0.06 mL / min or less, more preferably 0.012 mL / min or less. If the leak rate is within this range, even if the infusion between the chambers is forgotten and instillation is performed, the infusion rate of the infusion is only one or two drops per minute, at which rate normal infusion cannot be performed. Therefore, it is apparent that the first liquid medicine storage chamber 15 and the second liquid chemical storage chamber 16 are not in communication with each other and mixed.

The lower limit of the leak rate is the liquid drugs filled with the high pressure steam sterilization in the container, that is, the first liquid medicine 11 in the first liquid medicine storage chamber 15, and the second liquid medicine storage chamber 16. When the liquid medicament 12 is carried out under conditions that bring the required sterility guarantee level, the first liquid medicament compartment 15, the second liquid medicament compartment 16, the effluent reservoir 17 and the outlet 21 ) Can produce conditions that can achieve the same level of aseptic guarantee, or that water or water vapor in the liquid state, at least 10 ^-6 or less, is less than or equal to the effluent reservoir and the outlet until high pressure steam sterilization is performed. It is a leak rate that can be allowed to leak from the liquid drug storage chamber into the space containing the effluent reservoir and the outlet in an amount sufficient to ensure the level of gender assurance.

This rate of leakage depends on various conditions such as the manufacture or storage of the drug-containing medical liquid container, the time from filling of the liquid drug to autoclaving, and the autoclave temperature and time of autoclaving, and cannot be specified numerically. The amount of water that must be present in the effluent reservoir and the outlet during high pressure steam sterilization to fill the effluent reservoir and the outlet with saturated steam and to effectively heat sterilize at the highest temperatures achievable during high pressure steam sterilization. Can be defined.

Specifically, the moisture content is defined in the attached table 1.1: Saturated steam pressure obtained from saturated steam of water, and Analysis Table 1: Water vapor pressure e in the conversion formula for the amount of humidity, which is described in JIS Z 8806, "Humidity Measurement Method". _It can be found using the formula (d _v = e M _v RT) which reduces to _v . Assuming that the highest temperature during autoclaving is 130.0 ° C, the saturated water vapor pressure e _s = 270.3 kPa obtained in Table 1.1 is adopted and the absolute temperature T (t / ° C = T / K-) defined in the same JIS Z 8806 is adopted. 273.15), the gas constant R = 8.314472 J · K ⁻¹ · mol ⁻¹ and the molar mass M _v = 18.01528 kg / mole of water are applied to the conversion equation in the Table 1 to determine the The required amount of liquid to be present in the effluent reservoir 17 and the outlet 21 to ensure the sterile state of the inner space containing is about 2 mg / cm ³ per space. In other words, a drug containing 2 μL / cm ³ of water is sufficient.

More specifically, assuming, for example, that the amount of space in the effluent reservoir is 30 cm ³ , the required amount of water is about 60 μL. It is also estimated that one drop in the drop infusion is about 60 μL, so that by using a water drop of about one drop of the drug, the space in the effluent reservoir and the outlet during high pressure steam sterilization is expected to be filled with saturated water vapor. In addition, since the maximum space of the effluent storage room is about 120 cm ³ , it is sufficient if at least 4 drops are present in the effluent storage room after autoclaving.

Sterility assurance can be defined by the method described in the scope text of Japanese Pharmacopoeia 14th Edition, General Information, 15 Terminal Sterilization and Sterilization Indicators. In particular, the same method used to verify the sterility guarantee of the liquid medicament may be used. As an example of the evaluation method, for example, if the overkill method is used, Bacillus available as ATCC 7953 having a D-value of 1 or more. Using a brush Russ (Bacillus stearothermophilus) paper strip-type biological indicator containing a known number of spores as stearate as a sterilization indicator, and puts the index in the storage chamber effluent. If the effluent storage room is large, many indicators are dispersed.

In the case of placing a plurality of biological indicators, examples of the location of the indicators include the corners and the center of the film-formed part in the effluent reservoir and also the inside of the outlet part. It is important to ensure that the cold spots in the effluent storage room are also sterilized, with little saturated water vapor reaching during autoclaving.

In this state, high pressure steam sterilization is carried out under conditions that ensure the sterility of the liquid drug storage chamber and the number of spores on the biological indicators is reduced. If a reduction of 12 kV is incurred, this means that aseptic guarantee levels of 10 ^-6 or less are obtained.

As for the non-liquid seal (non-liquid dividing portion) that separates the second liquid drug storage chamber and the effluent reservoir, in addition to the above-described embodiment, a dividing member may be formed therein, for example, as shown in FIG. 4. . In the medical liquid container 31 shown in FIG. 4, the non-liquid seal (non-liquid dividing member) 34 in which the dividing member 35 separates the second liquid drug storage chamber 32 and the effluent storage chamber 33 is provided. Is provided. The sealing parts on both sides of the dividing member 35 are sealing parts which cannot be peeled off. The dividing member 35 is formed of, for example, a flexible resin, and the separator 36 is provided so as to cover the entire surface thereof. In addition, pores 36a are formed in the separator 36 to allow a small amount of the second liquid medicine 37 contained in the second liquid medicine storage chamber 32 to leak into the outflow storage chamber 33.

In addition, in the medical liquid container 31 as described above, a small amount of the second liquid chemical agent 37 flows into the effluent storage chamber 33 through the pores 36a, so that a small amount flowed in at the time of high pressure steam sterilization treatment. Due to the vapor generated from the second liquid medicament 37 of the effluent storage compartment 33 and the outlet 39 can be assured aseptic level of guarantee equivalent to the sterility guarantee level of the liquid medicament compartment. Alternatively, the pores 36a serve to pass moisture in the liquid medicament and introduce it into the effluent reservoir 33 in steam or liquid state during high pressure steam sterilization. Thus, the pores may not only be formed, but may also be filled with a second liquid medicament 12, or a liquid-permeable or moisture-permeable material capable of passing moisture in the vapor or liquid state into the effluent reservoir 33.

The separation membrane 36 of the medical liquid container 31 has a peeling strength of the liquid-tight sealing portion (liquid-sealed portion) 40 that separates the first liquid chemical storage chamber 38 and the second liquid chemical storage chamber 32. It may be sufficient if it is formed to have greater strength. By forming in this way, when the 1st liquid chemical | medical agent storage chamber 38 or the 2nd liquid chemical | medical agent storage chamber 32 is pressed at the time of use, the liquid-tight sealing part 40 will be peeled first, and the 1st liquid chemical | medical agent 41 and The second liquid medication 37 is mixed to form a mixed liquid medication. Pressing the first liquid chemical storage chamber 38 or the second liquid chemical storage chamber 32 further causes the separator 36 to rupture by the mixed liquid chemical, and as a result, the mixed liquid chemical can escape from the outlet 39. Can be.

As for the non-liquid seal (non-liquid dividing portion) separating the second liquid drug storage chamber and the effluent reservoir, a cylindrical dividing member may be formed therein, for example, as shown in FIG. 5. In the medical liquid container 51 shown in FIG. 5, a splitting member (not shown) is provided in a non-liquid seal (non-liquid dividing member) 54 that separates the second liquid drug storage chamber 52 and the effluent storage chamber 53. 55) is provided. The partition member 55 is formed of flexible resin, for example, and is provided with a thin resin film (isolation film) 56 so as to cover the entire surface thereof. Further, pores 56a for leaking a small amount of the second liquid medicine 57 contained in the second liquid medicine storage chamber 52 into the effluent storage chamber 53 are formed in the resin film 56. The pores 56a may also be formed as perforations that participate in facilitating rupture.

In addition, in such a medical liquid container 51, a small amount of the second liquid chemicals 57 flows into the effluent storage chamber 53 through the pores 56a, so that a small amount flowed in at the time of high pressure steam sterilization treatment. Due to the vapor generated from the second liquid medicament 57 of the effluent storage chamber 53 and the outlet 59 may be guaranteed a sterility guarantee level equivalent to the sterility guarantee level of the liquid pharmaceutical storage compartment. Alternatively, the pores 56a serve to pass moisture in the liquid medicament and introduce it into the effluent reservoir 53 in steam or liquid state upon autoclaving. Thus, a liquid-permeable or moisture-permeable material may be used in place of the porous film.

Furthermore, in the above-mentioned medical liquid container 51, the resin film 56 is a liquid-tight seal part (liquid-sealing partition part) which separates the 1st liquid chemical | medical agent storage chamber 58 and the 2nd liquid chemical | medical agent storage chamber 52 ( It is formed to have a burst strength greater than the peel strength of 60). When the first liquid chemical storage chamber 58 or the second liquid chemical storage chamber 52 is pressed in use, the liquid-tight seal 60 is first peeled off to form a mixed liquid chemical, and then the first liquid chemical storage chamber Pressing the 58 or the second liquid medicine storage chamber 52 further causes the resin film 56 to rupture with the mixed liquid medicine, and as a result, the mixed liquid medicine can escape from the outlet 59.

As shown in FIG. 6, the non-liquid seal (non-liquid dividing portion) that separates the second liquid medication compartment and the effluent reservoir may, for example, have a plug for shielding. In the medical liquid container 71 shown in FIG. 6A, a shielding member is attached to a non-liquid seal (non-liquid dividing member) 74 that separates the second liquid drug storage chamber 72 and the effluent storage chamber 73. 75 is provided. The shielding member 75 includes a cylindrical communication opening 85 and a shielding plug 86 for closing the communication opening 85. Examples of the shape of the shielding member 75 include a cylindrical shielding plug 86a blocking the communication opening 85 as shown in Fig. 6B, or a spherical shielding plug 86b as shown in Fig. 6C. Clogging the communication opening 85 is included.

In addition, in the medical liquid container 71, since a small amount of the second liquid medicine 77 is introduced through the fine gap 87 between the communication opening 85 and the shielding plug 86, at the time of high pressure steam sterilization treatment, As a result, the vapor generated from the small amount of the second liquid medicine 77 introduced into the effluent storage chamber 73 and the outlet 79 may ensure a sterility guarantee level equivalent to that of the liquid medicine storage chamber. . Alternatively, a fine gap between the communication opening 85 and the shielding plug 86 allows moisture in the liquid medicament to pass and introduces it into the effluent reservoir 53 in vapor or liquid state during high pressure steam sterilization. Play a role.

Also in the medical liquid container 71 as described above, the communication opening 85 and the shielding plug 86 seal the liquid seal that separates the first liquid chemical storage chamber 78 and the second liquid chemical storage chamber 72. Engagement with a strength greater than the peeling strength of the portion (liquid tightly divided portion) 80. When the first liquid chemical storage chamber 78 or the second liquid chemical storage chamber 72 is pressed in use, the liquid-tight sealing portion 80 is first peeled off to form a mixed liquid chemical, and then the first liquid chemical storage chamber Further pressing the 78 or the second liquid medicine storage chamber 72 causes the plug 86 for shielding in the communication opening 85 to be pushed by the mixed liquid medicine to be removed from the communication opening 85, and as a result, the mixed liquid. Drugs can exit from the outlet 79.

As shown in FIG. 7, the non-liquid seal (non-liquid dividing portion) separating the second liquid medicament compartment and the effluent reservoir may, for example, interpose a liquid-permeable or moisture-permeable material between the peelable sealing materials. The sealing part manufactured by making it may be sufficient. Water-permeable or moisture-permeable materials are not particularly limited, but examples thereof include sterilized paper, porous nonwoven fabric including high density polyethylene fibers, and polyester mixed with cellulose.

In the medical liquid container 91 shown in FIG. 7, a non-liquid seal (non-liquid dividing portion) in which the sterilizing paper 95 separates the second liquid drug storage chamber 92 and the effluent storage chamber 93 ( 94). Further, in the medical liquid container 91 as described above, since a small amount of the second liquid medicine 97 flows in through the sterilization paper 95 having a liquid permeability or moisture permeability, a small amount of the flowed in the high pressure steam sterilization treatment Due to the vapor generated from the second liquid medicament 97, the sterility assurance level equivalent to the sterility assurance level of the liquid medicament storage chamber may also be ensured for the effluent reservoir 93 and the outlet 99.

When the first liquid chemical storage chamber 98 or the second liquid chemical storage chamber 92 is pressed in use, the liquid-tight sealing portion 100 is first peeled off to form a mixed liquid chemical and then the first liquid chemical storage chamber Further pressing the 98 or the second liquid medicine storage chamber 92 causes the non-liquid seal (non-liquid seal partition) 94 to be peeled off by the mixed liquid medicine, so that the mixed liquid medicine It is possible to escape from the outlet 99.

According to the medical liquid container of the present invention, a small amount of liquid medicine or liquid in the liquid stored in the liquid medicine storage chamber leaks, flows into the effluent storage chamber through the non-liquid-splicing member, and a small amount of the liquid pharmaceutical flowing into the effluent storage chamber. The water in the vaporizes due to the heat of the high pressure steam during the high pressure steam sterilization process and spreads to the entire outflow storage chamber, whereby the outflow storage chamber is equivalent to the liquid pharmaceutical storage chamber by sterilization under the same conditions as in the heat sterilization of the liquid chemical storage chamber. It may be in a sterile guarantee level.

Conventionally known liquid pharmaceutical bags, with means for preventing forgetting to open the dividing wall, can be treated with radiation using an electron beam, gamma rays, or the like to sterilize the effluent reservoir, or ethylene oxide gas, formaldehyde gas, or the like. It must be treated with chemical sterilization treatment. However, in the present invention, the non-liquid dividing portion is used as a dividing wall for separating the liquid drug storage chamber and the effluent storage chamber, and by allowing a small amount of water in the liquid drug contained in the liquid drug storage chamber to leak into the effluent storage chamber, Silver may be sterilized by this small amount of the introduced liquid medicine or water in the liquid medicine during high pressure steam sterilization, and radiation treatment or chemical sterilization treatment for sterilizing the effluent reservoir may be omitted. As a result, the simplification of the sterilization step for the medical preparation in the liquid pharmaceutical bag, and the reduction of the production cost can be realized, and at the same time the sterility of the whole liquid medicine bag with the effluent reservoir which does not forget to open the partition wall. Can be guaranteed.

Claims (6)

A plurality of medical liquid storage chambers partitioned in communication with each other, and an effluent storage chamber in which a liquid pharmaceutical outlet is formed therein; A liquid-tight dividing portion for liquid-tightly separating the liquid pharmaceutical compartments from each other, and a non-liquid-separated portion for non-liquid-separating portion between at least one of the liquid pharmaceutical compartments and the effluent reservoir, The non-liquid-split portion is a peelable seal, a membrane which is rupturable by a rise in pressure in the liquid medicine compartment, or a shielding plug capable of blocking or opening a communication opening, each of the liquid medicine or the liquid medicine. A medical liquid container having pores that allow a small amount of water to permeate into the effluent reservoir. The medical liquid container according to claim 1, wherein the liquid-tight portion, the non-liquid portion, or both are in communication due to the pressure rise in the liquid medicine compartment. The medical liquid container according to claim 1, wherein the non-liquid-dividing portion is not in communication by a pressure rise in a liquid medicine storage chamber in which the liquid-liquid dividing portion begins to communicate. The medical liquid container of claim 1, wherein the liquid-tight partition includes a peelable seal. delete The medical liquid container according to claim 1, wherein the non-liquid seal divided portion comprises a seal obtained by interposing a liquid-permeable and / or moisture-permeable material between the peelable sealing materials.

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