WO2001022913A1 - Infusion container and method of storing freeze-dried medicine - Google Patents
Infusion container and method of storing freeze-dried medicine Download PDFInfo
- Publication number
- WO2001022913A1 WO2001022913A1 PCT/JP2000/006590 JP0006590W WO0122913A1 WO 2001022913 A1 WO2001022913 A1 WO 2001022913A1 JP 0006590 W JP0006590 W JP 0006590W WO 0122913 A1 WO0122913 A1 WO 0122913A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- container
- drug
- storage chamber
- small container
- freeze
- Prior art date
Links
- 239000003814 drug Substances 0.000 title claims abstract description 143
- 238000001802 infusion Methods 0.000 title claims abstract description 40
- 238000000034 method Methods 0.000 title claims abstract description 10
- 238000004108 freeze drying Methods 0.000 claims abstract description 21
- 239000007788 liquid Substances 0.000 claims abstract description 8
- 238000003860 storage Methods 0.000 claims description 95
- 229940079593 drug Drugs 0.000 claims description 92
- 238000004891 communication Methods 0.000 claims description 19
- 229920003002 synthetic resin Polymers 0.000 claims description 4
- 239000000057 synthetic resin Substances 0.000 claims description 4
- 238000007796 conventional method Methods 0.000 claims description 3
- 229910052751 metal Inorganic materials 0.000 claims description 3
- 239000002184 metal Substances 0.000 claims description 3
- 230000002093 peripheral effect Effects 0.000 claims 2
- 238000007789 sealing Methods 0.000 claims 1
- 239000000243 solution Substances 0.000 description 45
- 229920001971 elastomer Polymers 0.000 description 20
- -1 polyethylene Polymers 0.000 description 13
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 9
- 229910052708 sodium Inorganic materials 0.000 description 9
- 239000011734 sodium Substances 0.000 description 9
- 239000004743 Polypropylene Substances 0.000 description 8
- 229920001155 polypropylene Polymers 0.000 description 8
- 239000004698 Polyethylene Substances 0.000 description 5
- 229920000573 polyethylene Polymers 0.000 description 5
- 229940123973 Oxygen scavenger Drugs 0.000 description 3
- 239000003242 anti bacterial agent Substances 0.000 description 3
- 229940088710 antibiotic agent Drugs 0.000 description 3
- 230000009089 cytolysis Effects 0.000 description 3
- 239000002274 desiccant Substances 0.000 description 3
- 239000003978 infusion fluid Substances 0.000 description 3
- 230000002934 lysing effect Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000000725 suspension Substances 0.000 description 3
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 2
- NWIBSHFKIJFRCO-WUDYKRTCSA-N Mytomycin Chemical compound C1N2C(C(C(C)=C(N)C3=O)=O)=C3[C@@H](COC(N)=O)[C@@]2(OC)[C@@H]2[C@H]1N2 NWIBSHFKIJFRCO-WUDYKRTCSA-N 0.000 description 2
- 125000004122 cyclic group Chemical group 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920000098 polyolefin Polymers 0.000 description 2
- 229920000915 polyvinyl chloride Polymers 0.000 description 2
- 239000004800 polyvinyl chloride Substances 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- NCFTXMQPRQZFMZ-WERGMSTESA-M Cefoperazone sodium Chemical compound [Na+].O=C1C(=O)N(CC)CCN1C(=O)N[C@H](C=1C=CC(O)=CC=1)C(=O)N[C@@H]1C(=O)N2C(C([O-])=O)=C(CSC=3N(N=NN=3)C)CS[C@@H]21 NCFTXMQPRQZFMZ-WERGMSTESA-M 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- GHASVSINZRGABV-UHFFFAOYSA-N Fluorouracil Chemical compound FC1=CNC(=O)NC1=O GHASVSINZRGABV-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 239000004699 Ultra-high molecular weight polyethylene Substances 0.000 description 1
- 108010059993 Vancomycin Proteins 0.000 description 1
- 229910021536 Zeolite Inorganic materials 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 239000003699 antiulcer agent Substances 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 238000007664 blowing Methods 0.000 description 1
- 229960003669 carbenicillin Drugs 0.000 description 1
- FPPNZSSZRUTDAP-UWFZAAFLSA-N carbenicillin Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)C(C(O)=O)C1=CC=CC=C1 FPPNZSSZRUTDAP-UWFZAAFLSA-N 0.000 description 1
- RRYMAQUWDLIUPV-BXKDBHETSA-N cefacetrile Chemical compound S1CC(COC(=O)C)=C(C(O)=O)N2C(=O)[C@@H](NC(=O)CC#N)[C@@H]12 RRYMAQUWDLIUPV-BXKDBHETSA-N 0.000 description 1
- OJMNTWPPFNMOCJ-CFOLLTDRSA-M cefamandole sodium Chemical compound [Na+].CN1N=NN=C1SCC1=C(C([O-])=O)N2C(=O)[C@@H](NC(=O)[C@H](O)C=3C=CC=CC=3)[C@H]2SC1 OJMNTWPPFNMOCJ-CFOLLTDRSA-M 0.000 description 1
- 229960003408 cefazolin sodium Drugs 0.000 description 1
- FLKYBGKDCCEQQM-WYUVZMMLSA-M cefazolin sodium Chemical compound [Na+].S1C(C)=NN=C1SCC1=C(C([O-])=O)N2C(=O)[C@@H](NC(=O)CN3N=NN=C3)[C@H]2SC1 FLKYBGKDCCEQQM-WYUVZMMLSA-M 0.000 description 1
- 229960003791 cefmenoxime Drugs 0.000 description 1
- MPTNDTIREFCQLK-UNVJPQNDSA-N cefmenoxime hydrochloride Chemical compound [H+].[Cl-].S([C@@H]1[C@@H](C(N1C=1C(O)=O)=O)NC(=O)\C(=N/OC)C=2N=C(N)SC=2)CC=1CSC1=NN=NN1C.S([C@@H]1[C@@H](C(N1C=1C(O)=O)=O)NC(=O)\C(=N/OC)C=2N=C(N)SC=2)CC=1CSC1=NN=NN1C MPTNDTIREFCQLK-UNVJPQNDSA-N 0.000 description 1
- 229960002417 cefoperazone sodium Drugs 0.000 description 1
- BWRRTAXZCKVRON-DGPOFWGLSA-N cefotiam dihydrochloride Chemical compound Cl.Cl.CN(C)CCN1N=NN=C1SCC1=C(C(O)=O)N2C(=O)[C@@H](NC(=O)CC=3N=C(N)SC=3)[C@H]2SC1 BWRRTAXZCKVRON-DGPOFWGLSA-N 0.000 description 1
- 229960004700 cefotiam hydrochloride Drugs 0.000 description 1
- 229960004366 ceftezole Drugs 0.000 description 1
- DZMVCVMFETWNIU-LDYMZIIASA-N ceftezole Chemical compound O=C([C@@H](NC(=O)CN1N=NN=C1)[C@H]1SC2)N1C(C(=O)O)=C2CSC1=NN=CS1 DZMVCVMFETWNIU-LDYMZIIASA-N 0.000 description 1
- 229960000636 ceftizoxime sodium Drugs 0.000 description 1
- ADLFUPFRVXCDMO-LIGXYSTNSA-M ceftizoxime sodium Chemical compound [Na+].N([C@@H]1C(N2C(=CCS[C@@H]21)C([O-])=O)=O)C(=O)\C(=N/OC)C1=CSC(N)=N1 ADLFUPFRVXCDMO-LIGXYSTNSA-M 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 229920005556 chlorobutyl Polymers 0.000 description 1
- 229960001380 cimetidine Drugs 0.000 description 1
- CCGSUNCLSOWKJO-UHFFFAOYSA-N cimetidine Chemical compound N#CNC(=N/C)\NCCSCC1=NC=N[C]1C CCGSUNCLSOWKJO-UHFFFAOYSA-N 0.000 description 1
- 239000012611 container material Substances 0.000 description 1
- 229910052802 copper Inorganic materials 0.000 description 1
- 239000010949 copper Substances 0.000 description 1
- 235000018417 cysteine Nutrition 0.000 description 1
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Natural products SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- HNPSIPDUKPIQMN-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane Chemical compound O=[Si]=O.O=[Al]O[Al]=O HNPSIPDUKPIQMN-UHFFFAOYSA-N 0.000 description 1
- FWRNIJIOFYDBES-ZQDFAFASSA-L disodium;(2s,5r,6r)-3,3-dimethyl-7-oxo-6-[[(2r)-2-phenyl-2-sulfonatoacetyl]amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate Chemical compound [Na+].[Na+].C1([C@H](C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C([O-])=O)(C)C)S([O-])(=O)=O)=CC=CC=C1 FWRNIJIOFYDBES-ZQDFAFASSA-L 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 229960001596 famotidine Drugs 0.000 description 1
- XUFQPHANEAPEMJ-UHFFFAOYSA-N famotidine Chemical compound NC(N)=NC1=NC(CSCCC(N)=NS(N)(=O)=O)=CS1 XUFQPHANEAPEMJ-UHFFFAOYSA-N 0.000 description 1
- 229960002949 fluorouracil Drugs 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 229920003049 isoprene rubber Polymers 0.000 description 1
- 239000006166 lysate Substances 0.000 description 1
- 229960004857 mitomycin Drugs 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 229960001520 ranitidine hydrochloride Drugs 0.000 description 1
- GGWBHVILAJZWKJ-KJEVSKRMSA-N ranitidine hydrochloride Chemical compound [H+].[Cl-].[O-][N+](=O)\C=C(/NC)NCCSCC1=CC=C(CN(C)C)O1 GGWBHVILAJZWKJ-KJEVSKRMSA-N 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 229940083542 sodium Drugs 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- WFWLQNSHRPWKFK-ZCFIWIBFSA-N tegafur Chemical compound O=C1NC(=O)C(F)=CN1[C@@H]1OCCC1 WFWLQNSHRPWKFK-ZCFIWIBFSA-N 0.000 description 1
- 229960001674 tegafur Drugs 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 229960004659 ticarcillin Drugs 0.000 description 1
- OHKOGUYZJXTSFX-KZFFXBSXSA-N ticarcillin Chemical compound C=1([C@@H](C(O)=O)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)C=CSC=1 OHKOGUYZJXTSFX-KZFFXBSXSA-N 0.000 description 1
- 229920000785 ultra high molecular weight polyethylene Polymers 0.000 description 1
- 210000000689 upper leg Anatomy 0.000 description 1
- 229960001572 vancomycin hydrochloride Drugs 0.000 description 1
- LCTORFDMHNKUSG-XTTLPDOESA-N vancomycin monohydrochloride Chemical compound Cl.O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)NC)[C@H]1C[C@](C)(N)[C@H](O)[C@H](C)O1 LCTORFDMHNKUSG-XTTLPDOESA-N 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 239000010457 zeolite Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2093—Containers having several compartments for products to be mixed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/202—Separating means
- A61J1/2031—Separating means having openings brought into alignment
Definitions
- 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.
- 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.
- a predetermined amount corresponding to one container unit
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- solutions 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.
- the cap member specifically includes, for example, a pierceable plug and a lid arbitrarily attached to the plug.
- 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.
- 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.
- 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).
- 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.
- a small container for freeze-drying a drug having a groove and a z- or concave groove.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- a suspension hole 23 as a suspension support is formed.
- 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.
- 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.
- 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 °.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. .
- 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.
- 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).
- the solution is poured into the medicine storage chamber 1 through the communication hole 5.
- 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).
- 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.
- a drip device not shown, the same applies hereinafter
- the liquid medicine mixed with the liquid can be taken out to the other end of the infusion device as an infusion.
- 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.
- 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.
- 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.
- 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.
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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
明 細 書 輸液用容器及びその凍結乾燥薬剤収納方法 技術分野 Description Transfusion container and lyophilized drug storage method
この発明は、 輸液用容器及びその凍結乾燥薬剤収納方法に関し、 さら に詳しくは、 凍結乾燥薬剤と、 その溶解液とを分離した状態で保存して おき、 使用直前に容器内で凍結乾燥薬剤と溶解液とを無菌的に混合し、 輸液として供給するための輸液用容器及びその輸液溶容器への凍結乾燥 薬剤の収納方法に関する。 背景技術 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
この種の輸液用容器に凍結乾燥薬剤を収納する場合には、 予め多量の 薬剤を適宜凍結乾燥し、 その凍結乾燥後の薬剤から所定量 (一容器単位 相当量) を小分けして輸液用容器の薬剤収納室に投入するか、 例えば、 特許第 2 5 5 1 8 8 1号、 第 2 7 6 7 0 1 6号のごとく、 予め特定の小 容器を用いて所定量の薬剤を凍結乾燥し、 凍結乾燥後、 その小容器から 凍結乾燥された薬剤を取り出し輸液用容器の薬剤収納室に投入していた。 しかし、 凍結乾燥後、 粉砕したり、 粉砕した凍結乾燥薬剤を所定量計 量して輸液用容器に充填するという一連の工程に非常に手間がかかり、 一方、 小容器を用いる場合には、 特に凍結乾燥薬剤を小容器特に凍結乾 燥薬剤を小容器から取り出すのに手間がかかるのに加えて小容器に高価 な凍結乾燥薬剤が残留してロスが生じる恐れがあるという問題があった。 そこで、 この発明の主要な目的の 1つは、 凍結乾燥薬剤を輸液用容器 の薬剤収納室に簡便に収納できる輸液用容器を提供することである。
この発明の主要な目的のもう 1つは、 凍結乾燥用小容器で凍結乾燥し た薬剤を残留によるロスなく輸液用容器の薬剤収納室に収納できる輸液 用容器を提供することである。 発明の開示 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
この発明は、 薬剤を収納する薬剤収納室と、 溶解液を収納し前記薬剤 収納室に連設された溶解液収納室とを備え、 前記薬剤収納室が、 口部分 を開放し凍結乾燥された薬剤を収容した小容器を収納し、 かつ前記溶解 液収納室とは保存時には区画され、 使用時には連通可能に構成されたこ とを特徴とする輸液用容器を提供する。 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.
すなわち、 この発明は、 薬剤収納室に、 口部分を開放し凍結乾燥され た薬剤を収容する小容器を収納することによって、 小容器内で予め凍結 乾燥された薬剤をそのまま小容器ごと薬剤収納室に収納でき、 それによ つてわざわざ薬剤凍結乾燥用小容器から薬剤を取り出す必要がなく、 薬 剤の収納工程が極めて容易になり、 更にそれによつて残留による薬剤の ロスをなくすことができる。 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.
ここで、 薬剤凍結乾燥用小容器は、 薬剤を溶解した液の状態 (凍結乾 燥前の状態) で 0 . 5〜4 . 0ミリリッ トル程度収納できると共に、 口 部分を開放して薬剤の凍結乾燥及び溶解液の通過を可能にし、 かつ輸液 用容器の薬剤収納室内に収納できる小さな容器状であることが必要で (例えば、 口部分の面積: 2 ~ 3 cm2 *高さ: 1 . 0〜: L . 5 cm)、 更にこ の小容器は、 輸液用容器の薬剤収納室内に位置決めできることが好まし い。 この小容器を薬剤収納室に位置決めする手段としては、 薬剤収納室 内に小容器の一部に係止する係止部を設けることであり、 この係止部の 具体例としては、 小容器の側壁に縦溝及び/又は底壁に凹溝をそれぞれ
形成し、 これらの縦溝及び/又は凹溝に係止するように薬剤収納室の容 器本体に突状部、 具体例として突部及び Z又は突条をそれそれ形成する ことを挙げることができる。 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.
なお、 この小容器は、 上述のとおり、 口部分を開放しているが、 この 口部分に、 溶解液を通過させるための開口部を有する蓋を具備してもよ い。 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.
また、 この小容器は、 ポリエチレン、 ポリプロピレン、 ポリ塩化ビニ ル、 環状ポリオレフインなどの合成樹脂又はアルミニウム、 ステンレス 鋼などの金属で構成され、 好ましくはポリエチレン、 ポリプロピレン又 は環状ポリオレフインで構成される。 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.
この発明の輸液用容器の薬剤収納室に、 小容器ごと収納される凍結乾 燥薬剤としては、 具体的には、 次の活性成分を例示できる。 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.
抗生剤としては、 セファゾリンナトリウム、 セフチゾキシムナトリウ ム、 塩酸セフォチアム、 塩酸セフメノキシム、 セファセトリルナトリウ ム、 セフアマンドールナトリウム、 セファロリジン、 セファタキシムナ トリウム、 セフォテ夕ンナトリウム、 セフオペラゾンナトリウム、 セフ スロジンナトリウム、 セフテゾールナトリウム、 セフビラミ ドナトリウ ム、 セフメ夕ゾ一ルナトリウム、 セフロキシナトリウム、 硫酸セフォク レスなどのセフエム系抗生物質、 またアンビシリンナトリウム、 カルべ ニシリンナトリゥム、 スルベニシリンナトリウム、 チカルシリンナトリ ゥムなどのベニシリン系抗生物質、 さらには塩酸バンコマイシンなどが ある。 抗腫瘍剤としては、 マイ トマイシン C、 フルォロウラシル、 テガ フール、 シ夕ラビンなどがある。 抗潰瘍剤としては、 ファモチジン、 塩 酸ラニチジン、 シメチジンなどがある。 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.
この発明の輸液用容器の溶解液収納室に収納される溶解液としては、
生理的食塩水、 ブドウ糖液または、 システィン、 トリブトファンなどを 添加したアミノ酸液などが挙げられるが、 特にこれらに限定されるもの ではない。 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.
この発明において、 キャップ部材は、 具体的には例えば、 刺通可能な 栓体と、 任意にこの栓体に被着される蓋部とからなる。 In the present invention, the cap member specifically includes, for example, a pierceable plug and a lid arbitrarily attached to the plug.
この発明の好ましい態様によれば、 薬剤収納室の口部を密封するキヤ ップ部材の上部に (具体例としては上述の蓋部の上に) 薬剤変質防止剤 収納室を形成し、 内部に薬剤変質防止剤として乾燥剤及び/又は脱酸素 剤を収納できるよう構成してもよい。 乾燥剤は、 湿気により変性する薬 剤の安定化を目的とするもので、 シリカゲル、 ゼォライ トなどを成分と するものが挙げられる。 また、 脱酸素剤は、 易酸化性を有する薬剤の変 性を防止するもので、 活性酸化鉄、 アモルファス銅などを用いたものが 挙げられる。 乾燥剤及び脱酸素剤は、 薬剤収納室に収納される薬剤の種 類などに応じて適宜使用され、 それそれ単独であるいは両者を同時に用 いてもよい。 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.
この発明における溶解液収納室は、 ポリエチレン、 ポリプロピレン、 ポリ塩化ビニルなどの比較的柔らかい合成樹脂のシートを融着して袋状 に成形されるか、 これらの合成樹脂をブロー成形した可撓性の容器であ ることが好ましい。 上述の薬剤収納室も、 一例としてこのような可撓性 の容器とし、 両容器を一体に形成してもよい (ダブルバッグ方式)。 この発明は、 別の観点によれば、 小さな容器状で、 その側壁及びノ又 は底壁に、 輸液用容器の薬剤収納室内に係止して容器自体を薬剤収納室 に位置決めするための縦溝及び z又は凹溝を有する薬剤凍結乾燥用小容 器を提供する。 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.
この発明は、 更に別の観点によれば、 薬剤を収納する薬剤収納室と、
溶解液を収納し、 内部を前記薬剤収納室の内部と使用時に連通可能に区 画され、 前記薬剤収納室に連設された溶解液収納室とからなる輸液用容 器の前記薬剤収納室に薬剤を収納するに際して、 口部分が開放された小 容器に薬剤を溶解した液を充填し、 常法により凍結乾燥した後、 凍結乾 燥された薬剤を前記小容器から取り出さずに前記小容器ごと前記薬剤収 納室に収納することを特徴とする輸液用容器の凍結乾燥薬剤収納方法を 提供する。 図面の簡単な説明 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
図 1は、 この発明に係る輸液用容器の実施の形態を示す縦断面図であ る。 FIG. 1 is a longitudinal sectional view showing an embodiment of an infusion container according to the present invention.
図 2は、 図 1とは 9 0 °異なる方向の縦断面図である。 FIG. 2 is a longitudinal sectional view in a direction different by 90 ° from FIG.
図 3は、 図 2の A— A断面図である。 FIG. 3 is a sectional view taken along line AA of FIG.
図 4は、 主として連通孔の開放状態を説明する一部分解斜視図である。 図 5は、 図 1の薬剤凍結乾燥用小容器を示し、 (A) は平面図、 (B ) は一部縦断面図、 (C ) は底面図である。 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.
図 6は、 図 5の薬剤凍結乾燥用小容器の斜視図である。 発明を実施するための最良の形態 FIG. 6 is a perspective view of the small container for freeze-drying a drug of FIG. BEST MODE FOR CARRYING OUT THE INVENTION
以下、 図面に示す実施の形態に基づいてこの発明を詳述する。 なお、 これによつてこの発明が限定されるものではない。 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.
図 1はこの発明に係る輸液用容器の実施の形態を示す縦断面図、 図 2 は図 1とは 9 0。異なる方向の縦断面図、 図 3は図 2の A— A断面図、 図 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は主として連通孔の開放状態を説明する一部分解斜視図、 図 5は図 1 の薬剤凍結乾燥用小容器を示し、 (A)は平面図、 (B )は一部縦断面図、
( C ) は底面図である。 図 6は、 図 5の薬剤凍結乾燥用小容器の斜視図 である。 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.
さて、 図 1及び 2に示す輸液用容器 1 0は、 凍結乾燥薬剤 (図示省略) を収納した薬剤収納室 1と、 溶解液 (図示省略) を収納した溶解液収納 室 2とから主として構成されている。 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.
薬剤収納室 1は、 広口の容器状で、 その底部を溶解液収納室 2に連設 された容器本体 8と、 この容器本体内に収納された薬剤凍結乾燥用小容 器 1 5及びこの小容器内で予め凍結乾燥され、 そのまま収納されている 凍結乾燥薬剤と、 キャップ部材 3とからなる。 そして容器本体 8は、 そ の上端部には、 キャップ部材 3を装着可能な口部 1 aを有し、 底部 6に は後述する連通孔 5を有し、 全体がポリプロピレンで一体に成型され、 溶解液収納室 2に比較して剛性を大きくされている。 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.
溶解液収納室 2は、透明なポリプロピレンにより液密で偏平な袋状(厚 み: 0 . 2〜0 . 5廳) にブロー成形され、 十分な可撓性と弾力性を有 している。 溶解液収納室 2の上部には、 薬剤収納室 1の下端部に形成さ れたポート 1 bに連接するフランジ状の口部 2 bが形成されている。 溶 解液収納室 2の下端の縁部 2 aには、 吊り下げ支持部としての吊り下げ 孔部 2 3が形成されている。 薬剤収納室 1のポート 1 bと溶解液収納室 2のフランジ状の口部 2 bとを、 熱溶着することにより、 薬剤収納室 1 が溶解液収納室 2に連設 (連接) される。 なお、 薬剤収納室 1と溶解液 収納室 2とは一体に成型されたものでもよい。 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.
溶解液収納室 2と液密に連接する薬剤収納室 1の底部 6には、 薬剤収 納室 1と溶解液収納室 2とを連通させるための連通孔 5 ( 5 a · 5 b ) が形成され、 更に薬剤収納室 1内に突出し、 連通孔 5に被さって密封す る突状部 7としての一対の突部 7 c · 7 dが形成されている。
これらの突部 7 c · 7 dは、 横に並んだ一対の塔状で、 ねじりに対する 強度を付与するために特にひれ状のリブ 7 f ■ 7 gを備え、 かつそれら の共通の底部分 7 eに扇状の切り欠き (又は開口) 7 a . 7 bを形成し てなる。 ここで、薬剤収納室 1の底部 6に形成された扇状の連通孔 5 a · 5 bは、 底部 6の中心で対向して形成され、 中心角度がいずれも約 9 0 ° である。 一方、 扇状の切り欠き 7 a · 7 bは上記の連通孔 5 a · 5 に 対応して形成されている。 従って、 突部 7 c · 7 dの回動により、 底部 分 7 eの切り欠き 7 a · 7 bと薬剤収納室 1の底部 6に形成された一対 の扇状の連通孔 5 a · 5 bとを合わせると、 薬剤収納室 1と溶解液収納 室 2とを連通させることができる。 なお、 7 hは底部分 7 e上に形成さ れた突状部 7の 1つとしての突条である。 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.
さて、 突部 7 c · 7 dは、 その先端がキャップ部材 3の後述するゴム 栓 2 0に形成された係合孔 2 0 d · 2 0 eにそれそれ挿入されて (係合 して) いる。 そして、 キャップ部材 3とゴム栓 2 0とは、 前者の天井部 分に形成れた Y字状ッメ 3 1 · 3 2を、 後者の上面部に形成された Y字 状凹部 2 1 · 2 2に係止させることによって、 キャップ部材 3の回動を ゴム栓 2 0へ確実に伝達できるように構成されている。 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.
従って、 図 1のごとく、 使用前は連通孔 5 a · 5 bは底部分 7 eによ つて液密に閉塞されているが、 キャップ部材 3の回動操作に伴って、 図 4のごとく係合孔 2 0 d · 2 0 eおよび突部 7 c · 7 dを介してその底 部分 7 eが回動し、 図 4のごとく連通孔 5 a * 5 bは切り欠き 7 a - 7 bと合わせられ、 薬剤収納室 1と溶解液収納室 2とを連通させることが できるわけである。 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.
なお、 ゴム栓 2 0 (特に後述する栓本体 2 0 a ) の下部表面には、 凍 結乾燥薬剤を溶解液に溶解させるときの回動を容易にするために (口部
1 aに対する摩擦抵抗を軽減するために) 超高分子ポリエチレンフィル ムをラミネート加工している。 また、 ゴム栓 2 0と、 薬剤収納室 1の口 部 l aと、 キャップ部材 3との間には、 液密性を向上させるために〇型 リングパヅキング 3 3を介在させている。 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.
一方、 突状部 7はポリプロピレン 1 0〜 3 0 %とポリエチレン 9 0〜 7 0 %を混合したもので、 薬剤収納室 1はポリプロピレン 1 0 0 %でそ れそれ形成され、 両者は、 凍結乾燥薬剤と溶解液とを混合するまでは、 樹 S旨接着され (仮止めされ)、 連通孔 5 a · 5 bの密封性が確保されてい なお、 薬剤収納室 1の容器本体 8の開口部の外周には、 等角度間隔で 2つの凸部 1 1 · 1 2を形成し、 一方、 キャップ部材 3の内面には 9 0 ° の範囲で凸部 1 1 · 1 2との相対移動を規制する凹溝 3 4 - 3 5を形成 している。 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.
また、 容器本体 8の外周には、 後述するキャップ部材 3を回転する際 に、 保持しやすくするために一対の段落部 4 0 · 4 1を 1 8 0。間隔にて 形成している (図 2参照)。 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).
薬剤収納室 1の口部 1 aには、 薬剤収納室 1を気密にするためにキヤ ップ部材 3のゴム栓 (栓体) 2 0が回動可能に揷入されている。 このゴ ム栓 2 0は、 大部分を占める、 薬剤 (固形) との安定性を向上させるた めに選択された塩素化ブチルゴム製の栓本体 2 0 aと、 この栓本体上面 の略中心に位置し、 キヤップ部材 3の蓋部 3 aの薬液取出部 4としての 切り欠き孔 3 bに対応して穿刺針の貫通後の液漏れを防止する小ゴム栓 部 2 0 bとの二重構造からなる。 この小ゴム栓部 2 0 bは復元性のよい イソプレンゴム製であり、 切り欠き孔 3 bで一部露出しているが、 ゴム 栓 2 0表面が汚染されないように切り欠き孔 3 bが上蓋部 9で保護され
ている。 そしてこの上蓋部 9は、 キャップ部材 3に溶着によって装着さ れ、 この上蓋部 9をその引張片 9 aを引っ張り、 溶着を破って開くこと により、 切り欠き孔 3 bを介して小ゴム栓部 2 0 bが現れるように構成 されている。 なお、 上蓋部 9はその上面を平坦とし、 凍結乾燥薬剤、 溶 解液が充填された輸液用容器 1 0を自立できるようにしている。 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.
そしてゴム栓 2 0の下面には、 穿刺針の刺通を容易にするための下凹 部 2 0 cと、 突部 7 c ' 7 dの先端部に係合する係合孔 2 0 d · 2 0 e とが形成されている。 これらの係合孔の直径は 2 ~ 6 mmである。 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.
図 1〜 6、 特に 5〜 6において、 薬剤凍結乾燥用小容器 1 5は、 小さ な略円筒容器状で、 その口部分を開放し、 かつその側壁及び底壁にそれ それ縦溝 3 6 · 3 7及び凹溝 (横溝) 3 8を連なって有し, ポリプロピ レンで平均肉厚: 0 . 5〜1 . 0腿にて成型されている。 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.
この小容器 1 5には、 凍結乾燥された薬剤がその小容器内で凍結乾燥 されたままの状態で入れられていて、 特に図 1〜4のごとく、 薬剤収納 室 1内に位置決めされている。 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. .
すなわち、 薬剤収納室 1の口部 1 aにキャップ部材 3のゴム栓 2 0を 嵌める前に、 小容器 1 5が口部 1 aを通じて入れられ、 その縦溝 3 6 · 3 7及び凹溝 3 8を、 突状部としての突部 7 c · 7 d及び突条 7 hにそ れそれ係合することによって位置決めされる。なお、薬剤の凍結乾燥は、 まず薬剤を溶解した液を小容器に充填し、 次いで別途用意された凍結乾 燥器内で常法にて行われた。 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.
輸液用容器 1 0は、 このような構成からなるので、 使用の際、 キヤヅ プ部材 3を回転操作すると、 それに伴ってゴム栓 2 0が回動し、 更にゴ ム栓 2 0の係合孔 2 0 d · 2 0 eを介して突部 7 c · 7 dも回動して薬 剤収納室 1の底部 6との樹脂接着 (仮止め) を破り、 薬剤収納室 1と溶
解液収納室 2の間に、 大きい連通孔 5 ( 5 a · 5 b ) を容易に形成する ことができる (特に図 4参照)。 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).
さらに輸液用容器 1 0を上下逆にするか、 または溶解液収納室 2を押 圧することにより、 溶解液を連通孔 5を介して薬剤収納室 1に流し込む。 かくして溶解液は、 薬剤収納室 1内に収納されている薬剤凍結乾燥用小 容器 1 5の口部分から入り込み、 小容器 1 5内の凍結乾燥薬剤をすばや く溶解する (通常、 凍結乾燥薬剤は溶解液に溶解しやすく、 瞬間的に溶 解する)。 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).
次いで、 上蓋部 9をその引張片 9 aによって取りはずして、 薬液取出 部 4としての切り欠き孔 3 bを開放し、 点滴具 (図示省略、 以下同様) に一体に接続された穿刺針を、 露出したゴム栓 2 0の小ゴム栓部 2 O b に刺通し、 さらに栓本体 2 0 aを刺通してから、 溶解液収納室 3の吊り 下げ孔部 2 3をスタンドに掛けると、 凍結乾燥薬剤と溶解液とを混合し てなる薬液を輸液として点滴具の他端側に取り出すことができる。 この ように、 上記実施の形態では、 薬剤収納室 1と溶解液収納室 2の連通操 作がキヤヅプ部材 3の回転によって極めて容易に達成される。 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.
なお、 輸液用容器 1 0は、 溶解液収納室 2自体の偏平な形状とその弾 力性により、 点滴時に外気を侵入させなくても (空気針を使用しなくて も) 最終的に平板状となって溶解液を排出でき、 点滴終了時まで薬液が 外気に一切触れることなく、 容器内の無菌性が保証されている。 また、 ゴム栓以外の容器素材は、 日局輸液用プラスチック容器試験に記載され ているポリエチレン及びポリプロピレンのみで構成されたオールプラス チック容器であるため、 通常、 輸液用容器 (注射用キット) で行われて I、る点滴終了時のガラス、 金属の分別廃棄操作も不要である。 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.
以上のごとく、 この輸液用容器によれば、 突状部が薬剤収納室の底部
に設けられた連通孔を密封してなり、 キヤップ部材の回転操作により、 ゴム栓を介してゴム栓に係合する突条部を底部から離して連通孔を開放 できるようになっているので、 薬剤収納室と溶解液収納室とを連通させ、 容易にかつ無菌的に輸液を調製して提供できる。 産業上の利用可能性 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
この発明によれば、 薬剤凍結乾燥用小容器内で予め凍結乾燥された薬 剤をそのまま薬剤凍結乾燥用小容器ごと薬剤収納室に収納してなり、 そ れによってわざわざ薬剤凍結乾燥用小容器から薬剤を取り出す必要がな く、 薬剤の収納工程が極めて容易になり、 更にそれによつて薬剤凍結乾 燥用小容器内に残留することによる薬剤ロスをなくすことができる。
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
1 . 薬剤を収納する薬剤収納室と、 溶解液を収納し前記薬剤収納室に連 設された溶解液収納室とを備え、 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,
前記薬剤収納室が、 口部分を開放し凍結乾燥された薬剤を収容した小 容器を収納し、 かつ前記溶解液収納室とは保存時には区画され、 使用時 には連通可能に構成されたことを特徴とする輸液用容器。 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 . 薬剤収納室が、 底部が溶解液収納室に連設された容器本体と、 この 容器本体の口部を密封するキヤップ部材とからなり、 小容器が前記容器 本体内に収納されている請求項 1に記載の輸液用容器。 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 . 容器本体が、 その内部に、 小容器の一部に係止し、 それによつて前 記小容器を位置決めする係止部を備えてなる請求項 2に記載の輸液用容 。 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 . 小容器が、 その側壁に縦溝及び/又は底壁に凹溝を有し、 容器本体 の係止部が、 前記縦溝及びノ又は凹溝にそれそれ係止し、 それによつて 前記小容器を位置決めする、 容器本体の底部に立設された突状部である 請求項 3に記載の輸液用容器。 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 . 小容器の縦溝が、 前記小容器の側周壁に周方向等間隔に 2以上形成 されてなる請求項 4に記載の輸液用容器。 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 .容器本体が、その底部に溶解液収納室との連通孔を有し、突状部が、 前記容器本体の底部上で移動可能であり、 かつその底部分により前記連 通孔を開放可能に密封し、 キャップ部材が、 前記突状部の先端部に係合 された係合部を有し、 キヤップ部材の回転操作により前記係合部及び突 状部を介して前記連通孔を開放可能とする請求項 4に記載の輸液用容器。 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 . 小容器が、 合成樹脂又は金属で構成されてなる請求項 1に記載の輸
液用容器。 7. The container according to claim 1, wherein the small container is made of synthetic resin or metal. Liquid container.
8 . 小さな容器状で、 その側壁及び/又は底壁に、 輸液用容器の薬剤収 納室内に係止して容器自体を薬剤収納室に位置決めするための縦溝及び /又は凹溝をそれそれ有する薬剤凍結乾燥用小容器。 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 . 縦溝が、 小容器の側周壁に周方向等間隔に 2以上形成されてなる請 求項 8に記載の薬剤凍結乾燥用小容器。 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.
1 0 . 薬剤を収納する薬剤収納室と、 溶解液を収納し、 内部を前記薬剤 収納室の内部と使用時に連通可能に区画され、 前記薬剤収納室に連設さ れた溶解液収納室とからなる輸液用容器の前記薬剤収納室に薬剤を収納 するに際して、 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
口部分が開放された小容器に薬剤を溶解した液を充填し、 常法により 凍結乾燥した後、 凍結乾燥された薬剤を前記小容器から取り出さずに前 記小容器ごと前記薬剤収納室に収納することを特徴とする輸液用容器の 凍結乾燥薬剤収納方法。
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:
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP00962838A EP1243245A4 (en) | 1999-09-30 | 2000-09-25 | Infusion container and method of storing freeze-dried medicine |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP27938899 | 1999-09-30 | ||
JP11/279388 | 1999-09-30 |
Publications (1)
Publication Number | Publication Date |
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WO2001022913A1 true WO2001022913A1 (en) | 2001-04-05 |
Family
ID=17610445
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2000/006590 WO2001022913A1 (en) | 1999-09-30 | 2000-09-25 | Infusion container and method of storing freeze-dried medicine |
Country Status (2)
Country | Link |
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EP (1) | EP1243245A4 (en) |
WO (1) | WO2001022913A1 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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GB2485254C (en) * | 2011-08-22 | 2013-12-25 | Eulysis Uk Ltd | A container having a recessed closure for drying and storing one or more active agents |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2551881B2 (en) * | 1991-06-26 | 1996-11-06 | 株式会社大塚製薬工場 | Freeze-drying container and method for producing freeze-dried drug in filled container |
EP0809994A1 (en) * | 1995-02-13 | 1997-12-03 | Fujisawa Pharmaceutical Co., Ltd. | Transfusion container |
JPH1080465A (en) * | 1996-07-19 | 1998-03-31 | Material Eng Tech Lab Inc | Vessel for medical treatment |
JP2767016B2 (en) * | 1992-07-14 | 1998-06-18 | 株式会社大塚製薬工場 | Freeze-drying container |
JPH10165480A (en) * | 1996-12-13 | 1998-06-23 | Material Eng Tech Lab Inc | Freeze-dried matter vessel and manufacture thereof |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3441179A (en) * | 1967-05-29 | 1969-04-29 | Ways & Means Inc | Mixing container |
FR2767514B1 (en) * | 1997-08-22 | 1999-11-05 | Dominique Mounier | MIXER BOTTLE COMBINING TWO INSULATED COMPONENTS BEFORE THEY ARE COLLECTED AND INJECTED WITH A SYRINGE |
-
2000
- 2000-09-25 WO PCT/JP2000/006590 patent/WO2001022913A1/en not_active Application Discontinuation
- 2000-09-25 EP EP00962838A patent/EP1243245A4/en not_active Withdrawn
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2551881B2 (en) * | 1991-06-26 | 1996-11-06 | 株式会社大塚製薬工場 | Freeze-drying container and method for producing freeze-dried drug in filled container |
JP2767016B2 (en) * | 1992-07-14 | 1998-06-18 | 株式会社大塚製薬工場 | Freeze-drying container |
EP0809994A1 (en) * | 1995-02-13 | 1997-12-03 | Fujisawa Pharmaceutical Co., Ltd. | Transfusion container |
JPH1080465A (en) * | 1996-07-19 | 1998-03-31 | Material Eng Tech Lab Inc | Vessel for medical treatment |
JPH10165480A (en) * | 1996-12-13 | 1998-06-23 | Material Eng Tech Lab Inc | Freeze-dried matter vessel and manufacture thereof |
Non-Patent Citations (1)
Title |
---|
See also references of EP1243245A4 * |
Also Published As
Publication number | Publication date |
---|---|
EP1243245A4 (en) | 2006-10-18 |
EP1243245A1 (en) | 2002-09-25 |
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