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

Container and freeze-drying the chemical accommodating method art that for bright fine manual infusion

This invention relates to containers and methods lyophilized medicament containing the transfusions detail further includes a lyophilized drug, to keep in a state of being separated and its solution, and freeze-dried medicament in the container just before use a solution aseptically mixed, to a method of storing lyophilized drug to fluid vessel and infusion 溶容 device for supplying as an infusion. BACKGROUND

When storing the lyophilized drug infusion container of this kind, previously large amount of the drug appropriately lyophilized fluid vessel in portions a predetermined amount (one container unit equivalent) from the drug after the lyophilization or put into the drug storage chamber, for example, No. 2 5 5 1 8 8 No. 1, as the second 7 6 7 0 1 6 No., and lyophilized a predetermined amount of the drug with the pre-specified small container , after lyophilization, it was put into the drug storage chamber of the infusion container retrieving an agent lyophilized from the small container. However, after lyophilization, or crushed, very laborious to a series of steps of the freeze-dried agent was ground by a predetermined amount weighing filled into infusion containers, on the other hand, in the case of using a small container, in particular lyophilized drug expensive small container particularly freeze drying 燥薬 agent in a small container in addition to the laborious to to retrieve from the small container lyophilized drug was a problem that there is a possibility that loss remaining occurs. Therefore, one of the main objectives of the present invention is to provide a fluid vessel that can easily house the lyophilized drug to the drug storage chamber of the fluid vessel. Another one of the main objectives of the present invention is to provide a fluid vessel that can be accommodated in the medicine storing chamber of the container without loss infusion due to residual drug was lyophilized in small container for lyophilization. Disclosure of the Invention

This invention includes a drug storage chamber for containing a drug, and a dissolved solution provided continuously dissolution liquid storing chamber in the housing and the drug storing chamber, said medicine container chamber, and lyophilized to open the mouth portion the small container containing a drug accommodated, and wherein the dissolving liquid storing chamber is defined at the time of storage, to provide a fluid vessel, characterized that it has been configured to communicate in use.

That is, the present invention is the medicine storage chamber, by housing the small container containing medicament which is lyophilized to open the mouth portion, previously lyophilized medication as it small container each medicine accommodating chamber with a small container can be stored, it'll connexion which eliminates the need to take out the drug from the small container the drug lyophilization, storage process of drug agent becomes extremely easy, it is possible to further eliminate the loss of the drug by by connexion remaining on it.

Here, the drug lyophilized for small container is in a state of solution prepared by dissolving the drug (state of freeze dried 燥前) from 0.5 to 4. With 0 Miriri' can Torr about storage, freeze agents and open mouth portion to allow the passage of drying and solution, and it is necessary small container shape that can be accommodated in the medicine container chamber of the fluid vessel (e.g., the area of the mouth portion: ² ~ 3 cm 2 * height:. 1 0 ~:. L 5 cm), further small container of this is not preferable to be able to position the medicine storage chamber of the infusion container. The means for positioning the small container into the drug storing chamber, and by providing the engaging portion for engaging a portion of the small container into the drug storing chamber, and specific examples of the engaging portion, the small container each form a groove on the longitudinal groove and / or bottom wall to the side wall, the protrusion on the container body of the medicine container chamber to lock these longitudinal grooves and / or grooves, projections and specific examples Z or ridges can be given to it it formed.

Incidentally, the small container, as described above, but to open the mouth portion, this mouth portion, but it may also be provided with a lid having an opening for passing the solution.

Furthermore, the small container, polyethylene, polypropylene, polyvinyl chloride le, is composed of metal such as synthetic resin or aluminum, stainless steel, such as cyclic polyolefin, preferably polyethylene, polypropylene or consists of cyclic polyolefin.

The drug storage chamber of the fluid vessel of the invention, the freeze-drying 燥薬 agent to be stored for each small container, specifically, can be exemplified the following active ingredients.

The antibiotic, cefazolin sodium, ceftizoxime sodium U beam, cefotiam hydrochloride, hydrochloric cefmenoxime, Sepharose Setori Luna thorium, Joseph Aman doll sodium, cephaloridine, Sefatakishimuna thorium, Sefote evening down sodium, Joseph opera betamethasone sodium, Joseph Ro Jin sodium, cefteram tetrazole sodium, Sefubirami Donatoriu arm, Sefume Yuzo one Le sodium, Se furo carboxymethyl sodium, cephem antibiotics also sodium AMBI cylinder, carbenium Western phosphorus sodium © beam, sulbenicillin sodium, such as sulfuric acid Sefoku less, Benishirin antibiotics such as ticarcillin sodium © beam news and the like vancomycin hydrochloride. The antitumor agent, mitomycin C, Furuorourashiru, Tega Fool, and the like shea evening Rabin. The antiulcer agent, famotidine, ranitidine hydrochloric acid, and the like cimetidine.

The solution accommodated in the dissolving liquid storing chamber of the fluid vessel of the invention, saline, dextrose solution, or, cysteine, but to the amino acid solution was added and Toributofan, is particularly limited to not.

In the present invention, the cap member, specifically, for example, consists of a pierceable plug body, a lid which is applied to the plug body arbitrarily.

According to a preferred embodiment of the invention, (on the lid portion of the above Examples) in the upper part of Canon-up member for sealing the mouth of the medicine container chamber to form a drug alteration preventive agent storage chamber, the interior it may be configured to be able to house the desiccant and / or deoxidant as a drug alteration preventive agent. Desiccant is for the purpose of stabilization of the drug agent for degradation by moisture, silica gel, include those with such a component Zeorai bets. Further, the oxygen scavenger is intended to prevent the denaturation of the drug having an oxidizable include those using active iron oxide, amorphous copper. Desiccant and deoxidizer is optionally used depending on the type of agent to be accommodated in the medicine storing chamber, it can have use it itself or at the same time both.

Dissolving liquid storing chamber in the present invention include polyethylene, polypropylene, or is formed by fusing a relatively soft synthetic resin sheet such as polyvinyl chloride into a bag shape, these synthetic resin was blow molded flexible container der Rukoto is preferable. Drug storing chamber above also, and such flexible containers as an example, may be formed integrally with both containers (double bag system). The present invention, according to another aspect, in a small container shape, its side walls and Roh or bottom wall, vertical for positioning the container itself to the drug storage chamber engaged with the medicine container chamber of the fluid vessel It provides an agent for lyophilization small container with grooves and z or grooves.

The present invention, according to a further aspect, the drug storing chamber for accommodating a drug, lysates were housed, which can communicate with the being demarcated wards the interior during use the interior of the drug storing chamber, to the drug storage chamber in housing the drug into the drug storage chamber of the infusion container comprising a continuously provided by dissolution liquid storing chamber, filled with a solution prepared by dissolving the drug in the small container mouth portion is opened, lyophilized by a conventional method after provides lyophilized medicine storing method of the infusion container, characterized in that housed in the small container by the medicament retract and chamber lyophilized medication without removing from the small container. BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a Ru longitudinal sectional view showing an embodiment of a fluid vessel according to the present invention.

2, the FIG. 1 is a longitudinal sectional view of the 9 0 ° different directions.

Figure 3 is a A- A sectional view of FIG.

Figure 4 is a partially exploded perspective view mainly illustrating the open state of the communication hole. Figure 5 shows the drug lyophilization small container of FIG. 1, (A) is a plan view, (B) is partially longitudinal sectional view, (C) is a bottom view.

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

It will hereinafter be described in detail by the present invention with reference to embodiments shown in the drawings. It should be noted that the present invention is not limited Te cowpea thereto.

1 is a longitudinal sectional view showing an embodiment of a fluid vessel according to the present invention, 9 0 and 2 Figure 1. Longitudinal sectional views of different directions, Figure 3 A- A sectional view of FIG. 2, FIG.

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

Now, 0 fluid vessel 1 shown in Figures 1 and 2 includes a medicine storing chamber 1 housing the freeze-dried agent (not shown), is composed primarily of lysates (not shown) accommodating a lysate storing chamber 2 which ing.

Medicine storing chamber 1 is a wide-mouth container-like, and the container body 8 provided continuously to the bottom of the dissolving liquid storing chamber 2, the small container 1 5 and the small agent lyophilized housed in the container body it is pre-lyophilized in a container, and freeze-drying agents that are directly housed, consisting of a cap member 3. The container body 8 is in the upper end of its having a possible mouth 1 a mounting cap member 3 has a communication hole 5, which will be described later in the bottom 6, the whole is integrally molded of polypropylene, It is larger rigidity compared to the dissolution liquid storage chamber 2.

Dissolving liquid storing chamber 2 is liquid-tight in a flat bag shape by transparent polypropylene (Thickness:.. 0 2-0 5 Hall) is blown into, and have sufficient flexibility and resiliency. At the top of the dissolving liquid storing chamber 2, a flange-shaped mouth portion 2 b which connects to port 1 b formed at the lower end of the medicine container chamber 1 is formed. The edge 2 a of the lower end of the dissolve solution storage chamber 2, the holes 2 3 hanging as a supporting portion hanging is formed. And a flange-shaped mouth portion 2 b of the dissolving liquid storing chamber 2 and port 1 b of the medicine container chamber 1, by heat welding, chemical accommodating chamber 1 is continuously provided (connected) to the solution storage chamber 2. It is also one which is molded integrally with the drug storing chamber 1 and the dissolving liquid storing chamber 2.

The bottom 6 of the medicine container chamber 1 which connects in a liquid-tight manner and dissolving liquid storing chamber 2, communication hole 5 for communicating the drug retract and chamber 1 and the dissolving liquid storing chamber 2 (5 a · 5 b) is formed is, and is further projected into the drug storage chamber 1, a pair of projections 7 c · 7 d as the protrusion 7 you sealed overlying the hole 5 formed. These projections 7 c · 7 d are side by side with a pair of tower-like, a rib 7 f ■ 7 g, especially fin-like in order to impart strength against twisting, and the common bottom portion thereof 7 fan-shaped notch e (or opening) 7 a. by forming a 7 b. Here, the communicating hole 5 a · 5 b fan-shaped formed on the bottom 6 of the medicine container chamber 1 is formed so as to face the center of the bottom 6, both the central angle is about 9 0 °. On the other hand, fan-shaped notch 7 a · 7 b is formed corresponding to the communicating hole 5 a · 5 above. Accordingly, projection by the rotation of 7 c · 7 d, and a bottom fraction 7 e of the notch 7 a · 7 b and the pair of fan-shaped communication holes 5 a · 5 b of which is formed in the bottom 6 of the medicine container chamber 1 Together, it is possible to communicate the drug storing chamber 1 and the dissolving liquid storing chamber 2. Incidentally, 7 h is the ridge of the one of the protruding portions 7 formed on the bottom portion 7 e.

Now, projection 7 c · 7 d is (by engagement) which it inserted and the rubber plug 2 engaging hole 2 0 formed 0 d · 2 0 e its tip is below the cap member 3 there. Then, the cap member 3 and the rubber plug 2 0, the Y-shaped Tsu menu 3 1 - 3 2 are formed on the former ceiling component, a Y-formed on the upper surface of the latter recess 2 1 - 2 by locked to 2, and the rotation of the cap member 3 is configured to be reliably transmitted to the rubber plug 2 0.

Accordingly, as in FIG. 1, but prior to use communication holes 5 a · 5 b is closed in by connexion liquid-tight in the bottom portion 7 e, in accordance with the rotation operation of the cap member 3, as in FIG. 4 engaged and a bottom portion 7 e is rotated via the Goana 2 0 d · 2 0 e and projection 7 c · 7 d, the communication hole 5 a * 5 b as shown in FIG. 4 notches 7 a - 7 b and keyed, it is not capable of communicating the drug accommodating chamber 1 and the dissolving liquid storing chamber 2.

Incidentally, the bottom surface of the rubber plug 2 0 (in particular, the plug body 2 0 a to be described later), the freeze of the rotation when the cause drying dissolved drug dissolution liquid in order to facilitate (friction against the mouth portion 1 a resistor are laminated a) ultra-high molecular polyethylene fill-time to mitigate. Further, the rubber plug 2 0, and the mouth portion la of the medicine container chamber 1, between the cap member 3, it is interposed a 〇 type Ringupadzukingu 3 3 in order to improve the liquid-tightness.

On the other hand, the protrusion 7 is a mixture of a 1 0-3 0% of polyethylene 9 0-7 0% polypropylene, the drug storing chamber 1 Polypropylene 1 0 0% Desolation is being it formed, both, lyophilized until mixing the drug and solution is tree S effect adhesive (temporarily fixed), the communication hole 5 a · 5 b sealability is still being secure, the opening of the medicine container chamber 1 of the container body 8 the outer periphery, two to form a convex portion 1 1, 1 2 at equal angular intervals, on the other hand, on the inner surface of the cap member 3 restricts the relative movement of the convex portion 1 1, 1 2 in the range of 9 0 ° groove 3 4 - 3 5 a form.

Further, on the outer circumference of the container body 8, at the time of rotating the cap member 3 to be described later, a pair of paragraph 4 in order to facilitate holding 0-4 1 1 8 0. They are formed at intervals (see FIG. 2).

The mouth portion 1 a of the medicine container chamber 1, a rubber plug (plug body) 2 0 Canon-up member 3 to the medicine storing chamber 1 airtight is 揷入 rotatably. The rubber stopper 2 0, the majority, the drug and the plug body 2 0 a chosen order to improve the stability of the manufactured chlorinated butyl rubber with (solid), substantially at the center of the plug body top surface position, and the double structure of the small rubber plug unit 2 0 b which corresponds to the cutout portion 3 b to prevent leakage after the penetration of the needle as the lid 3 a chemical extraction portion 4 of the cap member 3 consisting of. The small rubber plug unit 2 0 b is made of good isoprene rubber resilient, notches are partially exposed in the hole 3 b but cutout portion 3 b is upper cover so that the rubber plug 2 0 surface not contaminated It is protected by section 9. The upper lid portion 9 is mounted by welding to the cap member 3, the upper cover 9 pull the pull piece 9 a, by opening beating welding notch through the hole 3 b Small rubber stopper portion 2 0 b are configured to appear. Incidentally, the upper cover portion 9 is flat and its upper surface, lyophilized agent, dissolve solution is to allow independence the fluid vessel 1 0 filled.

And on the lower surface of the rubber plug 2 0, and the lower concave portion 2 0 c for facilitating piercing of the puncture needle, the engaging hole 2 0 d · engaging the tip portion of the projecting portion 7 c '7 d and 2 0 e is formed. The diameter of these engagement holes are 2 ~ 6 mm.

1 to 6, in particular 5-6, pharmaceutical lyophilization small container 1 5 is a small substantially cylindrical container shape, opens the mouth portion, and it it longitudinal grooves 3 6 - to the side and bottom walls 3 7 and grooves (lateral grooves) 3 8 continuous have an average thickness in Polypropylene:.. 0 5 to 1 are molded at 0 thigh.

The small container 1 5, have been placed in a state in which a lyophilized drug is lyophilized in the small container, in particular as in FIGS. 1-4, positioning the medicine storage chamber 1 .

That is, before the mouth portion 1 a of the medicine container chamber 1 fitting the rubber stopper 2 0 of the cap member 3, the small container 1 5 is placed through the mouth 1 a, Part longitudinal grooves 3 6.3 7 and grooves 3 8, is positioned by protrusion 7 c · 7 d and ridges 7 h Niso is that engagement of the projecting portion. Incidentally, lyophilization of the drug, first a solution prepared by dissolving the drug was charged into a small container, then held at a conventional method in the freeze drying 燥器 prepared separately.

Fluid vessel 1 0, since such a configuration, in use, when rotating the Kiyadzu flop member 3, the rubber plug 2 0 is rotated along with it, further engaging hole of rubber stopper 2 0 2 0 d · 2 0 through e projection 7 c · 7 d be rotated to break the resin adhesion of the bottom 6 of the drug agent storage chamber 1 (temporary fixing), the drug storing chamber 1 and dissolve the suspension storage between the chamber 2, a large passage 5 (5 a · 5 b) can be easily formed (see in particular Figure 4).

Furthermore either the fluid vessel 1 0 upside down, or by pressure press solution storage chamber 2, solution through the communicating hole 5 flow into the drug storing chamber 1 a. Thus lysates, enters from the mouth portion of the drug lyophilization small container 1 5 accommodated in the medicine storing chamber 1, the small container 1 5 in a freeze-dried drug to quick and dissolution (usually lyophilized drug easily dissolved into solution, instantaneously dissolve).

Then, the upper cover 9 removed by the tensile strips 9 a, the cutout portion 3 b of the chemical removal section 4 is opened, infusion device (not shown, hereinafter the same) of the puncture needle integrally connected to the exposed and pierce the small rubber plug portion 2 O b of the rubber plug 2 0, from further piercing the plug body 2 0 a, multiplied by hanging holes 2 3 of the dissolution liquid storage chamber 3 to the stand, dissolving a lyophilized drug it can be taken out chemical formed by mixing the liquid to the other end of the infusion device as an infusion. Thus, in the above embodiment, the communication operation of the medicine container chamber 1 and dissolving liquid storing chamber 2 is very easily achieved by rotating the Kiyadzupu member 3.

Incidentally, fluid vessel 1 0 lysates by flat shape and its bullet power resistance of the storage room 2 itself, even without invade the outside air during infusion (without using the air needle) finally flat and is able discharged solution, without chemical touches all the open air until the end of infusion, sterility in the container is guaranteed. The container material other than rubber plugs are the all-plastic container made only of polyethylene and polypropylene are described in a plastic container test day station infusion, typically rows fluid vessel (injectable kit) We and I, Ru intravenous drip at the end of a glass of, also separate disposal operation of the metal is not required.

As described above, according to the fluid vessel, the protruding portion is to seal the communicating hole provided at the bottom of the medicine container chamber, engaging the rotating operation of the cap member through the rubber stopper into a rubber stopper since the ridges away from the bottom has to be open communication holes that, a dissolving liquid storing chamber with the drug storing chamber communicated, can be provided by preparing an easily and aseptically infusion. Industrial Applicability

According to the present invention, it becomes then housed in pharmaceutical lyophilization small container each medicine storing chamber previously lyophilized drug agents in pharmaceutical freeze drying small container, all the way from the small container the drug lyophilized by Re their need to remove the drug rather name, drug storage process becomes extremely easy, it is possible to further eliminate the drug loss due to residual by the connexion agent freeze drying 燥用 small vessel it.

Claims

The scope of the claims

1. A drug accommodating chamber for accommodating a drug, solution was accommodating a dissolving liquid storing chamber which is continuously provided on the drug storing chamber,

Said medicament housing chamber, housing a small container containing a drug that is lyophilized to open the mouth portion, and wherein the dissolving liquid storing chamber is defined at the time of storage, which is configured to be communicated at the time of use infusion container which is characterized.

2. Chemical accommodating chamber, a container body bottom portion is provided continuously to the solution storage chamber consists of a cap member for sealing the mouth of the container body, wherein the small container is housed in the container body fluid vessel according to claim 1.

3. Container body, in its interior, infusion volumes of claim 2 comprising comprises an engagement portion which engages a portion of the small container, it positions the by connexion pre Symbol small container.

4. Small container has a recessed groove in the longitudinal groove and / or bottom wall to the side wall, the locking portion of the container body, it locks it engaged in the longitudinal groove and Roh or grooves, it'll connexion the positioning the small container, fluid vessel according to claim 3, wherein the protruding portion provided upright on the bottom of the container body.

5. Flutes small container, the fluid vessel according to claim 4 comprising formed 2 or more small container side wall in the circumferential direction at equal intervals.

6. Container body has a communicating hole of the dissolving liquid storing chamber at its bottom, the protrusion is movable in the bottom of the container body, and allows opening the communication hole by its bottom portion sealed in, the cap member has an engaging portion which is engaged with the distal end portion of the projecting ridge portion, it can be opened to the communication hole through the engaging portion and the butt-shaped section by rotational operation of the cap member infusion container according to claim 4,.

7. Small containers, transportation liquid container according to claim 1, formed by a synthetic resin or metal.

8. Small in container shape, its side walls and / or bottom wall, a longitudinal groove and / or grooves for positioning the container itself engaged in drug retract and chamber of fluid vessel to the medicine storing chamber which it drug lyophilization small container having.

9. Flutes are pharmaceutical lyophilization small container according to 請 Motomeko 8 consisting formed more in the circumferential direction at equal intervals on the side wall of the small container.

1 0. And chemical accommodating chamber for accommodating a drug, solution was accommodated inside the communicatively to be partitioned when using the inside of the drug storing chamber, and continuously provided dissolution liquid storing chamber to the medicine storing chamber in housing the drug into the drug storage chamber of the fluid vessel made of,

Filled with liquid mouth portion is dissolved the drug in the small container is opened by a conventional method was lyophilized, freeze-dried drug contained before Symbol small container each of the medicine storing chamber without removing from the small container lyophilized medicament containing method of the infusion container, characterized by.