WO2001022913A1

WO2001022913A1 - Infusion container and method of storing freeze-dried medicine

Info

Publication number: WO2001022913A1
Application number: PCT/JP2000/006590
Authority: WO
Inventors: Seizo Sunago; Jiro Fujisaki; Osamu Takahata
Original assignee: Fujisawa Pharmaceutical Co., Ltd.
Priority date: 1999-09-30
Filing date: 2000-09-25
Publication date: 2001-04-05
Also published as: EP1243245A4; EP1243245A1

Abstract

An infusion container comprising a medicine storing room (1) and a dissolving liquid storing room (2) continuously connected with the medicine storing room (1), wherein the medicine storing room (1) stores therein a small container (15) opened at the mouth portion thereof and storing a freeze-dried medicine, and is so constituted as to be partitioned from the storing room (2) when the container is preserved and to be able to communicate with it when in use, whereby a medicine freeze-dried in advance in the small container (15) can be stored in the medicine storing room (1) intact along with the small container (15), and the medicine need not be taken out from the medicine freeze-drying small container, thereby making a medicine storing process very simple and thus eliminating a loss by a remaining medicine.

Description

Description Transfusion container and lyophilized drug storage method

The present invention relates to an infusion container and a method for accommodating a lyophilized drug, and more particularly, to a method for storing a lyophilized drug and its lysate in a separated state, and storing the lyophilized drug in a container immediately before use. The present invention relates to an infusion container for aseptically mixing a lysis solution and supplying it as an infusion solution, and a method for storing a lyophilized drug in the infusion solution container. Background art

When storing a freeze-dried drug in this type of infusion container, a large amount of the drug is appropriately freeze-dried in advance, and a predetermined amount (corresponding to one container unit) is subdivided from the freeze-dried drug to obtain an infusion container. Or freeze-dry a predetermined amount of drug in a specific small container in advance, as in Patent Nos. 25511881 and 27671016. After freeze-drying, the freeze-dried drug was taken out of the small container and put into the drug storage room of the infusion container. However, after freeze-drying, a series of steps of crushing or weighing a predetermined amount of the crushed lyophilized drug into a container for infusion is very time-consuming.On the other hand, when a small container is used, There is a problem that it takes time and effort to remove the lyophilized drug from the small container, especially the lyophilized drug from the small container, and that the expensive lyophilized drug may remain in the small container and cause loss. Therefore, one of the main objects of the present invention is to provide an infusion container capable of easily storing a lyophilized drug in a drug storage room of the infusion container. Another main object of the present invention is to provide an infusion container capable of storing a drug freeze-dried in a small freeze-drying container in a drug storage chamber of the infusion container without loss due to residue. Disclosure of the invention

The present invention includes a drug storage chamber for storing a drug, and a solution storage chamber for storing a solution and connected to the drug storage chamber, wherein the drug storage chamber has a mouth portion opened and freeze-dried. The present invention provides an infusion container, which accommodates a small container containing a drug, is separated from the solution storage chamber during storage, and is communicable when used.

That is, according to the present invention, by storing a small container for holding a freeze-dried drug by opening the mouth portion in the drug storage chamber, the drug previously freeze-dried in the small container is stored in the drug storage chamber together with the small container. Therefore, there is no need to take out the drug from the small container for freeze-drying the drug, and the process of storing the drug becomes extremely easy, and further, the loss of the drug due to the residue can be eliminated.

Here, the small container for freeze-drying a drug can store about 0.5 to 4.0 milliliters in a liquid state in which the drug is dissolved (before freeze-drying), and freezes the drug by opening the mouth. It is necessary to have a small container that allows drying and passage of the solution and that can be stored in the medicine storage room of the infusion container (eg, mouth area: 2 to 3 cm ² * height: 1.0) ~: L. 5 cm), and it is preferable that this small container can be positioned in the medicine storage room of the infusion container. A means for positioning the small container in the medicine storage chamber is to provide a locking part for locking a part of the small container in the medicine storage chamber. A specific example of the locking part is a small container. A vertical groove on the side wall and / or a concave groove on the bottom wall respectively Formed on the container main body of the medicine storage chamber so as to be engaged with these vertical grooves and / or concave grooves. it can.

Although the small container has an open mouth as described above, the small mouth may be provided with a lid having an opening for allowing the solution to pass therethrough.

The small container is made of a synthetic resin such as polyethylene, polypropylene, polyvinyl chloride, or cyclic polyolefin or a metal such as aluminum or stainless steel, and is preferably made of polyethylene, polypropylene, or cyclic polyolefin.

Specific examples of the freeze-dried drug stored in the drug storage chamber of the infusion container of the present invention together with the small container include the following active ingredients.

Antibiotics include cefazolin sodium, ceftizoxime sodium, cefotiam hydrochloride, cefmenoxime hydrochloride, cefacetril sodium, cefamandole sodium, cephalorizine, cefataxime sodium, cefotenone sodium, cefoperazone sodium, cefoperone sodium Cefem antibiotics such as gin sodium, ceftezole sodium, cefviramid sodium, cefumesol sodium, cefuroxy sodium, cefoclesulfate, etc., as well as ambicilin sodium, carbenicillin sodium, sulbenicillin sodium Benicillin antibiotics, such as ticarcillin sodium, and vancomycin hydrochloride. Antitumor agents include mitomycin C, fluorouracil, tegafur, and shirababine. Antiulcer agents include famotidine, ranitidine hydrochloride and cimetidine.

As the solution stored in the solution storage chamber of the infusion container of the present invention, Examples include, but are not limited to, physiological saline, glucose solution, or amino acid solution to which cysteine, tritophan, etc. are added.

In the present invention, the cap member specifically includes, for example, a pierceable plug and a lid arbitrarily attached to the plug.

According to a preferred embodiment of the present invention, a drug-deterioration preventing agent storage chamber is formed on the upper part of the cap member that seals the mouth of the drug storage chamber (specifically, on the lid described above). You may comprise so that a desiccant and / or an oxygen scavenger can be accommodated as a chemical-alteration inhibitor. The desiccant is intended to stabilize a drug that is denatured by moisture, and includes those containing silica gel, zeolite, or the like as a component. Further, the oxygen scavenger prevents deterioration of the easily oxidizable drug, and examples thereof include those using active iron oxide, amorphous copper, or the like. The desiccant and the oxygen scavenger are appropriately used depending on the type of the drug stored in the drug storage chamber, and may be used alone or simultaneously.

The solution storage chamber in the present invention is formed by fusing a sheet of a relatively soft synthetic resin such as polyethylene, polypropylene, or polyvinyl chloride into a bag, or by blowing these synthetic resins into a flexible bag. It is preferably a container. As an example, the above-mentioned medicine storage chamber may also be formed of such a flexible container, and both containers may be integrally formed (double bag system). According to another aspect of the present invention, there is provided a small container having a vertical side wall and a bottom or bottom wall for locking the container itself in the drug storage chamber by locking the container itself in the drug storage chamber. Provided is a small container for freeze-drying a drug having a groove and a z- or concave groove.

According to yet another aspect, the present invention provides a medicine storage chamber for storing a medicine, A solution is stored therein, and the inside is partitioned with the inside of the medicine storage chamber so as to be communicable when used, and the solution storage chamber is connected to the medicine storage chamber. When storing a drug, a small container with an open mouth is filled with a solution in which the drug is dissolved, freeze-dried by a conventional method, and the freeze-dried drug is taken out of the small container without removing the small container. A method for storing a freeze-dried medicine for an infusion container, characterized by being housed in the medicine storage room, is provided. BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a longitudinal sectional view showing an embodiment of an infusion container according to the present invention.

FIG. 2 is a longitudinal sectional view in a direction different by 90 ° from FIG.

FIG. 3 is a sectional view taken along line AA of FIG.

FIG. 4 is a partially exploded perspective view mainly illustrating an open state of the communication hole. FIG. 5 shows the small container for freeze-drying of the drug of FIG. 1, (A) is a plan view, (B) is a partial longitudinal sectional view, and (C) is a bottom view.

FIG. 6 is a perspective view of the small container for freeze-drying a drug of FIG. BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, the present invention will be described in detail based on an embodiment shown in the drawings. However, the present invention is not limited by this.

FIG. 1 is a longitudinal sectional view showing an embodiment of an infusion container according to the present invention, and FIG. Longitudinal sectional view in different directions, Fig. 3 is A-A sectional view of Fig. 2, Fig.

4 is a partially exploded perspective view mainly illustrating an open state of the communication hole, FIG. 5 shows the small container for freeze-drying the drug of FIG. 1, (A) is a plan view, (B) is a partial longitudinal sectional view, (C) is a bottom view. FIG. 6 is a perspective view of the small container for freeze-drying a drug of FIG.

The infusion container 10 shown in FIGS. 1 and 2 is mainly composed of a drug storage chamber 1 for storing a lyophilized drug (not shown) and a lysis solution storage chamber 2 for storing a lysing solution (not shown). ing.

The medicine storage chamber 1 is a wide-mouthed container, the bottom of which is connected to the container body 8 connected to the solution storage chamber 2, and the medicine freeze-drying small containers 15 and 15 stored in the container body. It comprises a freeze-dried drug that has been freeze-dried in a container in advance and is stored as it is, and a cap member 3. The container body 8 has, at its upper end, an opening 1a to which the cap member 3 can be attached, and at the bottom 6, a communication hole 5 to be described later. The rigidity is increased compared to the solution storage chamber 2.

The solution storage chamber 2 is blow-molded from a transparent polypropylene in a liquid-tight and flat bag shape (thickness: 0.2 to 0.5 hall), and has sufficient flexibility and elasticity. At the upper part of the solution storage chamber 2, a flange-shaped mouth 2 b connected to a port 1 b formed at the lower end of the medicine storage chamber 1 is formed. At the edge 2 a at the lower end of the solution storage chamber 2, a suspension hole 23 as a suspension support is formed. By thermally welding the port 1 b of the drug storage chamber 1 and the flange-shaped mouth 2 b of the solution storage chamber 2, the drug storage chamber 1 is connected (connected) to the solution storage chamber 2. The medicine storage chamber 1 and the solution storage chamber 2 may be integrally molded.

A communication hole 5 (5a, 5b) for communicating between the drug storage chamber 1 and the solution storage chamber 2 is formed at the bottom 6 of the drug storage chamber 1 which is connected to the solution storage chamber 2 in a liquid-tight manner. Further, a pair of protrusions 7 c and 7 d are formed as protrusions 7 that protrude into the medicine storage chamber 1 and cover and seal the communication holes 5. These projections 7c and 7d are a pair of side-by-side towers, especially provided with fin-like ribs 7f7g to provide strength against torsion, and their common bottom part 7c A fan-shaped notch (or opening) 7a.7b is formed in e. Here, the fan-shaped communication holes 5a and 5b formed in the bottom portion 6 of the medicine storage chamber 1 are formed to face each other at the center of the bottom portion 6, and the center angles are all about 90 °. On the other hand, the fan-shaped notches 7a and 7b are formed corresponding to the communication holes 5a and 5 described above. Therefore, by the rotation of the projections 7c and 7d, the notches 7a and 7b of the bottom 7e and a pair of fan-shaped communication holes 5a and 5b formed in the bottom 6 of the medicine storage chamber 1 are formed. By combining, the medicine storage chamber 1 and the solution storage chamber 2 can be communicated. 7h is a ridge as one of the protrusions 7 formed on the bottom portion 7e.

The protruding portions 7c and 7d are inserted (engaged) into the engaging holes 20d and 20e formed in the rubber plug 20 of the cap member 3 described later, respectively. I have. The cap member 3 and the rubber plug 20 are formed by combining the former Y-shaped socket 31 formed on the ceiling portion with the Y-shaped recessed portion 2 formed on the upper surface portion of the latter. By locking the cap 2, the rotation of the cap member 3 can be reliably transmitted to the rubber plug 20.

Therefore, as shown in FIG. 1, the communication holes 5a and 5b are closed in a liquid-tight manner by the bottom portion 7e before use, but as shown in FIG. The bottom portion 7e rotates through the through holes 20d and 20e and the protrusions 7c and 7d, and the communication holes 5a * 5b are cutout 7a-7b as shown in Fig. 4. Thus, the medicine storage chamber 1 and the solution storage chamber 2 can communicate with each other.

The lower surface of the rubber stopper 20 (particularly the stopper body 20a described later) is provided on the lower surface of the rubber stopper 20 to facilitate rotation when the freeze-dried drug is dissolved in the dissolving solution. Ultra-high molecular weight polyethylene film is laminated (to reduce frictional resistance to 1a). A ring-shaped packing 33 is interposed between the rubber stopper 20, the mouth la of the medicine storage chamber 1, and the cap member 3 to improve liquid tightness.

On the other hand, the protrusion 7 is a mixture of 10 to 30% of polypropylene and 90 to 70% of polyethylene, and the drug storage chamber 1 is formed of 100% of polypropylene, and both are freeze-dried. Until the medicine and the dissolving solution are mixed, the tree is adhered (temporarily fixed), and the communication holes 5a and 5b are sealed tightly. Two protrusions 1 1 and 1 2 are formed on the outer circumference at equal angular intervals, while the inner surface of the cap member 3 restricts relative movement with the protrusions 1 1 and 1 2 within a range of 90 °. Grooves 3 4-35 are formed.

Further, a pair of paragraph portions 40 and 41 are provided 180 around the outer periphery of the container body 8 to facilitate holding the cap member 3 described later when the cap member 3 is rotated. They are formed at intervals (see Fig. 2).

A rubber stopper (plug) 20 of the cap member 3 is rotatably inserted into the mouth 1 a of the medicine storage chamber 1 to make the medicine storage chamber 1 airtight. The rubber stopper 20 is composed of a chlorinated butyl rubber stopper body 20a, which is selected to improve the stability with a large amount of a drug (solid), and a center of the stopper body approximately at the center. Double structure with a small rubber stopper part 20b that prevents liquid leakage after penetration of the puncture needle corresponding to the cutout hole 3b as the chemical solution take-out part 4 of the lid part 3a of the cap member 3 Consists of This small rubber stopper portion 20b is made of isoprene rubber with good resilience, and is partially exposed at the notch hole 3b. Protected by part 9 ing. The upper lid 9 is attached to the cap member 3 by welding, and the upper lid 9 is pulled open by breaking the weld by pulling the tension piece 9a, so that the small rubber plug is inserted through the cutout hole 3b. It is configured so that 20b appears. The upper surface of the upper lid 9 is flat so that the infusion container 10 filled with the lyophilized drug and the lysing solution can stand on its own.

The lower surface of the rubber stopper 20 has a lower concave portion 20c for facilitating the penetration of the puncture needle, and an engaging hole 20d for engaging the tip of the protrusion 7c'7d. 20 e are formed. The diameter of these engagement holes is 2 to 6 mm.

In Figs. 1-6, especially 5-6, the small container 15 for freeze-drying of the drug is a small, substantially cylindrical container, the mouth of which is opened, and the side walls and the bottom wall have vertical grooves 36 37 and concave grooves (transverse grooves) 38 in a row, and are molded from polypropylene with an average thickness of 0.5 to 1.0 thigh.

The small container 15 contains the lyophilized drug as it is lyophilized in the small container, and is particularly positioned in the medicine storage chamber 1 as shown in FIGS. .

That is, before the rubber stopper 20 of the cap member 3 is fitted to the mouth 1 a of the medicine storage chamber 1, the small container 15 is put through the mouth 1 a, and the vertical grooves 36, 37 and the concave grooves 3 are formed. 8 are respectively engaged with the protrusions 7c and 7d as protrusions and the protrusion 7h. The freeze-drying of the drug was performed by first filling a small container with a solution in which the drug was dissolved, and then in a freeze-dryer prepared separately by a conventional method.

Since the infusion container 10 has such a structure, when the cap member 3 is rotated during use, the rubber stopper 20 rotates with the rotation, and further, the engagement hole of the rubber stopper 20 is formed. The protrusions 7c and 7d also rotate through 20d and 20e to break the resin bond (temporary fixation) with the bottom 6 of the drug storage chamber 1 and melt with the drug storage chamber 1. Large communication holes 5 (5a and 5b) can be easily formed between the solution storage chambers 2 (particularly, see FIG. 4).

Further, by inverting the infusion container 10 upside down or pressing the solution storage chamber 2, the solution is poured into the medicine storage chamber 1 through the communication hole 5. Thus, the lysing solution enters through the mouth of the small container 15 for freeze-drying of drug contained in the drug storage chamber 1 and rapidly dissolves the freeze-dried drug in the small container 15 (usually, Easy to dissolve in dissolving solution, dissolves instantaneously).

Next, the upper cover 9 is removed by the pulling piece 9a, the cutout hole 3b as the chemical solution outlet 4 is opened, and the puncture needle integrally connected to a drip device (not shown, the same applies hereinafter) is exposed. After piercing the small rubber stopper 2 O b of the rubber stopper 20 and the stopper main body 20 a, and hanging the suspension hole 23 of the lysis solution storage chamber 3 on the stand, The liquid medicine mixed with the liquid can be taken out to the other end of the infusion device as an infusion. As described above, in the above-described embodiment, the communication operation between the medicine storage chamber 1 and the solution storage chamber 2 is very easily achieved by the rotation of the cap member 3.

The infusion container 10 has a flat shape due to the flat shape of the solution storage chamber 2 itself and its elasticity, so that it does not need to allow outside air to enter during drip (even if an air needle is not used). As a result, the solution can be discharged, and the chemical solution does not come into contact with the outside air until the end of the infusion, and the sterility in the container is guaranteed. In addition, since the container material other than the rubber stopper is an all-plastic container consisting only of polyethylene and polypropylene as described in the plastic container test for infusion in the Japanese Pharmacopoeia, it is usually performed in an infusion container (injection kit). It is not necessary to separate and discard glass and metal at the end of drip.

As described above, according to this infusion container, the protruding portion is located at the bottom of the medicine storage chamber. The communication hole provided in the seal is sealed, and by rotating the cap member, the ridge engaging the rubber stopper via the rubber stopper can be separated from the bottom to open the communication hole. The infusion solution can be easily and aseptically prepared and provided by connecting the drug storage room and the solution storage room. Industrial applicability

According to the present invention, the medicine freeze-dried in advance in the medicine freeze-drying small container is stored as it is in the medicine storage room together with the medicine freeze-drying small container. There is no need to take out the drug, which greatly facilitates the process of storing the drug, thereby eliminating drug loss due to the drug remaining in the small container for freeze-drying.

Claims

The scope of the claims

1. A drug storage chamber for storing a drug, and a solution storage chamber for storing a solution and connected to the drug storage chamber,

The medicine storage chamber is configured to store a small container containing a freeze-dried medicine with an open mouth portion, and to be separated from the solution storage chamber during storage and to be communicable when used. Characteristic infusion container.

2. The medicine storage chamber comprises a container body having a bottom portion connected to the solution storage chamber, and a cap member for sealing the mouth of the container body, wherein the small container is housed in the container body. Item 4. An infusion container according to Item 1.

3. The infusion container according to claim 2, wherein the container main body is provided therein with a locking portion which is locked to a part of the small container and thereby positions the small container.

4. The small container has a vertical groove on its side wall and / or a concave groove on the bottom wall, and the locking portion of the container body is respectively locked on the vertical groove and the groove or the concave groove. 4. The infusion container according to claim 3, wherein the container is a protruding portion that stands on the bottom of the container body for positioning the small container.

5. The infusion container according to claim 4, wherein two or more longitudinal grooves of the small container are formed at equal circumferential intervals on the side peripheral wall of the small container.

6.The container body has a communication hole with the solution storage chamber at the bottom thereof, the protrusion is movable on the bottom of the container body, and the communication hole can be opened by the bottom part. The cap member has an engaging portion engaged with the tip of the projecting portion, and the communication hole can be opened through the engaging portion and the projecting portion by rotating the cap member. 5. The infusion container according to claim 4, wherein:

7. The container according to claim 1, wherein the small container is made of synthetic resin or metal. Liquid container.

8. In the form of a small container, the side walls and / or the bottom wall may be provided with vertical and / or concave grooves for locking in the medicine storage room of the infusion container and positioning the container itself in the medicine storage room. A small container for freeze-drying of a drug.

9. The small container for freeze-drying a drug according to claim 8, wherein two or more vertical grooves are formed on the side peripheral wall of the small container at equal circumferential intervals.

10. A drug storage chamber for storing a drug, a solution storage chamber, and a solution storage chamber, which is partitioned so that the inside thereof can communicate with the inside of the drug storage chamber when used, and is connected to the drug storage chamber. When storing a drug in the drug storage chamber of an infusion container made of

A small container with an open mouth is filled with the liquid in which the drug has been dissolved, freeze-dried by a conventional method, and the freeze-dried drug is stored together with the small container in the drug storage room without being removed from the small container. A method for storing a lyophilized drug in an infusion container, comprising: