WO2015174358A1 - Tamperproof covering film, packaging container and prefilled syringe - Google Patents

Tamperproof covering film, packaging container and prefilled syringe Download PDF

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Publication number
WO2015174358A1
WO2015174358A1 PCT/JP2015/063430 JP2015063430W WO2015174358A1 WO 2015174358 A1 WO2015174358 A1 WO 2015174358A1 JP 2015063430 W JP2015063430 W JP 2015063430W WO 2015174358 A1 WO2015174358 A1 WO 2015174358A1
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WO
WIPO (PCT)
Prior art keywords
cut
cap
notch
coating film
cuts
Prior art date
Application number
PCT/JP2015/063430
Other languages
French (fr)
Japanese (ja)
Inventor
忠義 前坂
宏典 小西
Original Assignee
大塚製薬株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 大塚製薬株式会社 filed Critical 大塚製薬株式会社
Priority to JP2016519242A priority Critical patent/JP6556704B2/en
Publication of WO2015174358A1 publication Critical patent/WO2015174358A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D55/00Accessories for container closures not otherwise provided for
    • B65D55/02Locking devices; Means for discouraging or indicating unauthorised opening or removal of closure
    • B65D55/06Deformable or tearable wires, strings, or strips; Use of seals, e.g. destructible locking pins
    • B65D55/08Annular elements encircling container necks

Definitions

  • the present invention relates to a coating film for preventing falsification, a packaging container provided with the coating film, and a prefilled syringe.
  • a coating film having a function of preventing falsification is externally provided at the boundary between the container body and the cap.
  • This coating film for preventing tampering is used not only for packaging containers for foods and pharmaceuticals, but also for syringes used in medicine, for example, prefilled syringes.
  • a prefilled syringe is a syringe in which a medicine is previously enclosed.
  • This prefilled syringe includes a syringe body and a cap that is detachably attached to the syringe body. In use, after removing the cap from the syringe body and exposing the injection needle connection portion, the injection needle connection portion A patient can be injected with a drug by attaching an injection needle to the patient.
  • the covering film is packaged so as to cover the boundary portion between the syringe body and the cap, and the covering film is formed with a plurality of cuts at intervals along the circumferential direction.
  • a plurality of cuts in the cover film are formed with inclined cuts that are inclined with respect to the cuts. Whether or not it has been opened is clearly identified.
  • the inclined cut is formed so as to extend in a direction opposite to the rotation direction of the cap and to be inclined at a predetermined angle with respect to the cut.
  • Patent Document 1 when the coating film described in Patent Document 1 is used for a prefilled syringe of a type in which the cap can rotate in both directions with respect to the syringe body or a prefilled syringe of a type in which the cap is pulled out without rotating with respect to the syringe body, If the cap is rotated in the same direction as the direction in which the cut extends or if the cap is pulled out, it is difficult for the opened coated film to bend due to the inclined cut, so whether the coated film has been opened or not. There is a problem that discrimination becomes difficult.
  • the present invention has been made in order to solve the above-mentioned problems, and the prefilled syringe of any type of a type in which the cap is rotatable only in one direction with respect to the syringe body and a type in which the cap is rotatable in both directions, and a cap are further provided. Even if there is a prefilled syringe that can be pulled out without rotating with respect to the syringe body, it provides a tamper-proof coating film that can clearly distinguish whether the cap has been opened and whether or not the cap has been opened. The purpose is to do.
  • the above-described object of the present invention is a falsification-preventing coating film, which is provided with a plurality of first cuts provided at intervals along the longitudinal direction, and is provided for each of the first cuts.
  • a second notch having a predetermined inclination angle with respect to the first notch and the second notch sandwiching the first notch and a third notch provided to form a quadrangle
  • the quadrilateral has a shape in which two sides do not intersect at least one of two corners on both sides of the side facing the first cut out of the four corners, or a side facing the first cut It is achieved by a coating film having a shape having an intermittent portion.
  • the third cut is provided so as to intersect with the second cut, and the third cut is provided so as to intersect every other second cut. More preferably, The third cut may be provided between two adjacent second cuts.
  • the third cut is provided in parallel with the first cut.
  • the second cut is provided so as to have an intersection with the first cut.
  • the inclination angle of the second cut with respect to the first cut is preferably 30 degrees to 150 degrees, and more preferably 45 degrees.
  • first cut, the second cut, and the third cut are formed in either a linear shape with continuous cuts or a perforated shape with discontinuous cuts.
  • the object of the present invention is a package comprising: a container body; a cap detachably attached to the container body; and a coating film having the above-described structure that is sheathed so as to cover the container body and a boundary portion of the cap. Also achieved by the container.
  • the object of the present invention is a prefilled comprising a syringe body, a cap detachably attached to the syringe body, and a coating film having the above-described structure that is sheathed so as to cover the boundary portion of the syringe body and the cap. Also achieved with a syringe.
  • the cap even if the cap is rotated in either the forward or reverse direction with respect to the syringe main body or the container main body, and even if the cap is pulled out without rotating with respect to the syringe main body or the container main body, Since the trace of opening is clearly left on the coating film, it can be surely discriminated whether or not it has been opened. Therefore, once the cap can be rotated only in one direction, the cap can be rotated in both directions, or the cap can be pulled out without rotating, any type of packaging container and prefilled syringe can be temporarily removed. By doing so, it is possible to satisfactorily determine whether or not tampering has occurred.
  • FIG. 1 shows the appearance of a tamper-resistant coating film 2 (hereinafter simply referred to as “coating film 2”) according to an embodiment of the present invention.
  • FIG. 2 has shown the external appearance of the prefilled syringe 1 which concerns on one Embodiment of this invention.
  • FIG. 3 has shown the external appearance of the state which removed the coating film 2 from the prefilled syringe 1 of FIG. 2, and
  • FIG. 4 has shown the external appearance of the state which decomposed
  • FIG. 5 has expanded and shown the principal part of the coating film 2 of FIG.1 and FIG.2.
  • the prefilled syringe 1 includes a cylindrical cylinder body 3 made of, for example, synthetic resin, and a cap 4 that is detachably attached to the cylinder body 3.
  • a syringe needle connecting portion 5 is integrally provided at the distal end portion of the cylinder body 3, and a plunger insertion opening 6 is opened at the rear end portion.
  • a protective cover 7 is attached to the injection needle connecting portion 5.
  • a plunger 8 is inserted into the plunger insertion port 6.
  • a front plug body 9, an intermediate plug body 10, and a rear plug body 11 are slidably provided on the inner peripheral surface of the cylinder body 3 in this embodiment from the front end side.
  • the first storage chamber 12 is formed in a sealed state between the front plug body 9 and the intermediate plug body 10, and the second storage chamber 13 is formed in a sealed state between the intermediate plug body 10 and the rear plug body 11. Yes.
  • the first storage chamber 12 stores a drug M such as powder or solid
  • the second storage chamber 13 stores a liquid L such as a solution or dispersion of the drug M.
  • the drug M may be a liquid drug.
  • the liquid L may be a drug solution different from the drug M stored in the first storage chamber 12 or distilled water for dilution.
  • the cap 4 is made of, for example, rubber, and has a shape in which a top surface portion 41 having an outer shape larger than the cylindrical portion 40 is integrally formed at one end of a cylindrical cylindrical portion 40 having both ends opened.
  • the cylindrical portion 40 can accommodate the protective cover 7 and the injection needle connecting portion 5 inside, and the injection needle connecting portion 5 is fitted in the cylindrical portion 40.
  • the cap 4 is difficult to be removed from the syringe body 3 because the inner peripheral surface of the tubular portion 40 is in contact with the outer peripheral surface of the injection needle connecting portion 5.
  • the cap 4 can be removed from the syringe main body 3 by pulling out the cylindrical portion 40 from the injection needle connecting portion 5, but can be easily detached from the syringe main body 3 by pulling out the cap 4 while rotating with respect to the syringe main body 3. It has become easier. In this way, the cap 4 can be detached from the syringe body 3 with or without being rotated with respect to the syringe body 3.
  • the cover film 2 is printed with a direction X that clearly indicates the rotation direction of the cap 4 when opened, but can be removed from the syringe body 3 by rotating the cap 4 in a direction opposite to the direction X. It is.
  • the coating film 2 has a rectangular outer shape when viewed from the front, and in this embodiment, the prefilled syringe 1 covers the boundary portion B between the syringe body 3 and the cap 4.
  • the boundary part B is wrapped around the outer peripheral surface.
  • a shrink film having heat shrinkability is suitably used.
  • the shrink film include films of polyethylene, polypropylene, polyethylene terephthalate, polyvinyl chloride, and the like. Of these, a polyethylene film is preferable in consideration of openability, shrinkage, environmental suitability, and the like.
  • An adhesive or pressure-sensitive adhesive layer is formed on the back surface of the covering film 2, and the back surface of the covering film 2 is attached to the outer peripheral surface of the prefilled syringe 1 so as to straddle the syringe body 3 and the cap 4. .
  • the covering film 2 can be used without particular limitation as long as it is a film usually used for packaging.
  • the coating film 2 has a first cut 14 extending in the circumferential direction (longitudinal direction in FIG. 1) in the vicinity of the boundary portion B between the syringe body 3 and the cap 4 along the circumferential direction (longitudinal direction in FIG. 1).
  • a plurality is provided with an interval S1. Whether the cap 4 is pulled out without rotating with respect to the syringe body 3 or when the cap 4 is pulled out while rotating in the forward or reverse direction with respect to the syringe body 3, The covering film 2 is easily broken and opened through one cut 14. Thereby, the cap 4 can be removed from the syringe body 3.
  • the coating film 2 is provided with one second notch 15 for each first notch 14.
  • the second cut 15 is provided so as to be inclined at a predetermined inclination angle ⁇ with respect to the first cut 14.
  • the inclination angle ⁇ formed by the second cut 15 and the first cut 14 is not particularly limited. Therefore, the second cut 15 may be inclined with respect to the first cut 14 while extending in either the forward or reverse direction of the circumferential direction, or an angle of 90 degrees with respect to the first cut 14.
  • the inclination angle ⁇ is preferably 30 ° to 150 °, more preferably 30 ° to 135 °, further preferably 45 ° or 135 °. In the example of FIG. 45 degrees.
  • the cap 4 when the cap 4 is detached from the syringe body 3 and the covering film 2 is opened, the cap 4 is either forward or reverse with respect to the syringe body 3. If the film is pulled out while rotating in the direction or without rotating, the covering film 2 after opening will bend the square F, but since the area of the square F can be increased to some extent, the opened trace remains clearly. It is.
  • the second notch 15 is formed so as to have an intersection with the first notch 14, and extends from the end of the first notch 14.
  • An L-shape is formed by two cuts 15.
  • the coating film 2 is provided with a plurality of third cuts 16 extending in the circumferential direction at predetermined positions.
  • This third notch 16 forms a square F with the first notch 14 and the two second notches 15 sandwiching the first notch 14, that is, the first notch 14 and the two adjacent notches
  • the cover film 2 is provided so that the figure surrounded by the four sides L1 to L4 of the second cut 15 and at least one third cut 16 is a square F.
  • This quadrangle F has an interval S2 in which at least one of the two corners on both sides of the side L4 facing the first notch 14 does not intersect with each other (L2, L4 or L3, L4). It has an open shape or a shape having an interrupted portion C (shown in FIG.
  • the third cut 16 is provided in parallel with the first cut 14, and the quadrangle F is a parallelogram.
  • the area of the quadrangle F can be increased to some extent, so that when the cap 4 is removed from the syringe body 3 and the covering film 2 is opened, there are traces. Is preferable because it remains clear.
  • the third cut 16 is not necessarily parallel to the first cut 14. If the area of the quadrangle F can be increased to some extent, the third cut 16 becomes the first cut 14. It may be formed so as to be inclined with respect to.
  • the distance S ⁇ b> 2 between the third notch 16 and the second notch 15 not intersecting with the third notch 16 is compared with the distance S ⁇ b> 1 between the adjacent first notches 14. It is preferably large, and more preferably 3 or more (S2 / S1 ⁇ 3) in the ratio of the length of the interval S2 to the interval S1 (the length in the circumferential direction). If the interval S1 is small, when the cap 4 is removed from the syringe body 3 and the covering film 2 is opened, the covering film 2 is continuously broken in the circumferential direction by the first cuts 14 and the covering film 2 is opened cleanly. It becomes easy to do. On the other hand, when the interval S2 is large, when the covering film 2 is broken at each first cut 14, the square F remains on the covering film 2 via the interval S2 and tends to be rolled up.
  • the preferable dimensions of the covering film 2 in the example of FIG. 5 are as follows. If the length of the covering film 2 in the longitudinal direction is 57 mm and the length in the short direction is 22 mm, the length of the first cut 14 is 2 4 mm, and the interval S1 between the adjacent first cuts 14 can be 0.6 mm. Further, the inclination angle ⁇ of the second cut 15 with respect to the first cut 14 is 45 degrees, the length of the third cut 16 is 3.0 mm, and the third cut 16 and the second cut that do not intersect each other. The interval S2 between 15 can be 1.0 mm or 2.0 mm. Further, the length of the second cut 15 can be set to 4.0 mm.
  • the third cuts 16 are provided in every other second cut 15 so as to intersect the second cuts 15, but as shown in FIG.
  • Each second notch 15 arranged may be provided so as to intersect with the second notch 15.
  • one side L ⁇ b> 4 of the quadrangle F is formed by a part of two adjacent third cuts 16, and the side L ⁇ b> 4 is intermittently formed by an interval between the two third cuts 16.
  • Part C is formed.
  • a square F having an interval S1 is formed.
  • the interrupted portion C is preferably larger than the interval S1, and the length (circumferential length) ratio of the interrupted portion C to the interval S1 is 3 or more. More preferably, (C / S1 ⁇ 3).
  • the third cut 16 may be provided between the two adjacent second cuts 15 without intersecting the second cut 15.
  • an interval S1 is provided between the first cut 14 and one of the two second cuts 15 sandwiching the first cut 14, and the third cut 16 is A square F having an interval S2 is formed between both of the two second cuts 15.
  • the interval S2 is preferably larger than the interval S1, and the length (circumferential length) ratio of the interval S2 to the interval S1 is 3 or more (C More preferably, / S1 ⁇ 3).
  • the third cuts 16 are not necessarily provided in every other second cut 15, but are provided in every other second cut 15 as shown in FIG. Compared with the examples of FIGS. 6 and 7, the plurality of third cuts 16 are arranged in the covering film 2 with a large separation interval.
  • the plurality of third cuts 16 are closely arranged in the coating film 2 with a small separation interval, the syringe body 3 and the cap are opened when the cap 4 is rotated with respect to the syringe body 3 to open the coating film 2.
  • the covering film 2 is broken and opened at the third cut 16 instead of the first cut 14 in the vicinity of the boundary portion B of the fourth line. Therefore, it is preferable that the third cuts 16 are provided for every other second cut 15 from the viewpoint of breaking the cover film 2 with the first cuts 14 and opening them.
  • the inclination angle ⁇ between the second notch 15 and the first notch 14 is smaller than 90 degrees in the example of FIG. 5, but even if the inclination angle ⁇ is 90 degrees as shown in FIG. Moreover, as shown in FIG. 9, the inclination angle ⁇ may exceed 90 degrees. In the examples of FIGS. 6 and 7, although not shown, the inclination angle ⁇ between the second cut 15 and the first cut 14 may be 90 degrees or exceeds 90 degrees. It may be set as appropriate.
  • the second notch 15 intersects with the first notch 14 so as to have an intersection, but it is not always necessary to intersect.
  • the first notch 14 may be provided so as to leave an interval S3 from the first notch 14 without having an intersection.
  • the square F surrounded by the notches 14 to 16 constituting the four sides L1 to L4 is compared with the first notch 14 and this as compared to the examples of FIGS.
  • the gaps S1 and S3 are formed.
  • the inclination angle ⁇ between the second notch 15 and the first notch 14 may be 90 degrees or exceeds 90 degrees. It may be set as appropriate.
  • the rectangular F having the first cut 14 as one side L1 and the second cut 15 and the third cut 16 as the remaining three sides L2 to L4 in the coating film 2 in the circumferential direction.
  • the cap 4 is rotated in either the forward or reverse direction with respect to the syringe body 3 when the cover film 2 is opened by removing the cap 4 from the syringe body 3. Even if the film is pulled out or pulled out without rotating, the coated film 2 after opening is wrinkled, and the opened trace remains clearly. Thereby, it can be discriminate
  • a fourth cut 17 other than the first to third cuts 14 to 16 may be provided in the coating film 2.
  • a fourth notch 17 that is arranged in parallel with the third incision 16 and extends in the circumferential direction so as to intersect the second incision 16.
  • a fourth cut extending in the circumferential direction is arranged in parallel with the third cut 16 and does not intersect the second cut 16 with respect to the respective cuts 14 to 16 in the example of FIG. 17 is further provided.
  • FIG. 13 for each of the incisions 14 to 16 in the example of FIG. 10, a fourth notch 17 that is arranged in parallel with the third incision 16 and extends in the circumferential direction so as to intersect the second incision 16.
  • a fourth notch 17 extending in the circumferential direction is formed so that the first notch 14 and the second notch 15 form a Z shape with respect to the notches 14 to 16 in the example of FIG. Furthermore, it is provided.
  • the fourth cut 17 other than the first to third cuts 14 to 16 can be provided in the same manner.
  • Two or more fourth notches 17 may be provided.
  • the fourth cut 17 does not need to extend in the circumferential direction, and can be provided in various modes as long as the formation of the square F by the first to third cuts 14 to 16 is not hindered.
  • the covering film 2 covering the cap 4 and the syringe main body 3 is formed. Then, it is opened by breaking at the plurality of first cuts 14. At that time, the covering film 2 has a square F surrounded by the first to third cuts 14 to 16 corresponding to the first cuts 14 arranged in the circumferential direction.
  • the square F leaves at least one corner (interval S ⁇ b> 2) on both sides of the side L ⁇ b> 4 facing the first cut 14 or the intermittent part C of the side L ⁇ b> 4. And drown.
  • the square F is bent not only when the cap 4 is rotated in the X direction with respect to the syringe body 3 but also when the cap 4 is rotated in the direction opposite to the X direction. In addition, even when the cap 4 is pulled out without being rotated, it occurs in each case. Therefore, once the cap 4 is removed from the syringe body 3 and the covering film 2 is opened, it is possible to reliably determine whether or not the cap 4 has been recapped. . Moreover, since the curving of the square F at the time of opening of the covering film 2 is larger than the curling due to the inclined cut in the prior art document 1, the opened trace becomes clearer.
  • interruption 15 inclines so that it may extend toward the direction X currently displayed as the rotation direction of the cap 4 on the coating film 2 like the example of FIG.
  • the quadrilateral F can be easily distorted, so that the covering film 2 can be opened easily and reliably.
  • the third notch 16 is provided in every other second notch 15 among the plurality of second notches 15 arranged in the circumferential direction
  • the three cuts 16 are arranged in the covering film 2 with a large separation interval. Therefore, when the cap 4 is rotated with respect to the syringe body 3 and the covering film 2 is opened, the first notch 14 in the vicinity of the boundary portion B of the syringe body 3 and the cap 4 is covered instead of the third notch 16. Since the film 2 can be reliably broken, the cap 4 can be easily detached from the syringe body 3 after the covering film 2 is opened.
  • each of the cuts 14 to 16 is formed in a linear shape with continuous cuts, but may be formed in a perforated form in which the cuts are discontinuously arranged.
  • each of the cuts 14 to 16 may consist of one continuous extending cut or a plurality of intermittent cuts.
  • the perforated shape may be a mode in which cuts having a uniform length are arranged in a discontinuous manner, or a mode in which cuts having a non-uniform length are arranged in a discontinuous manner.
  • the notch in which the two notches are provided with a space therebetween as in the second notch 15 and the third notch 16 shown in FIG. 16 is formed in a perforated shape.
  • a portion B having no cut is provided at a portion (intersection) where the second cut 15 and the third cut 16 intersect, and the second cut 15 and the third cut 16 are The shape is broken at the intersection.
  • the interval between the two cuts can be about 0.1 mm to 1 mm.
  • the second notch 15 is provided so as to leave an interval S3 from the first notch 14 without having an intersection with the first notch 14.
  • a portion B having no cut is provided at a portion (intersection) where the second cut 15 and the third cut 16 intersect, and the second cut 15 is the first cut.
  • 14 is provided so as to leave an interval S3 without having an intersection with the coating film 2, when the coating film 2 is wound around the outer peripheral surface of the prefilled syringe 1 by heat shrinkage, the coating film 2 is formed at each of the notches 14-16. It can be wrapped neatly without opening.
  • FIG. 16 is made into the shape which interrupted the 2nd notch 15 and the 3rd notch 16 at the intersection with respect to the example of FIG. 10, FIG.5, FIG.6, FIG.8, FIG. 11 and 13, the second cut 15 and the third cut 16 may be cut off at the intersections.
  • the first cut 14 crosses at the end of the first cut 14.
  • intersects in the intermediate part of 14 may be sufficient.
  • the 2nd notch 15 is terminated in the cross
  • the said embodiment demonstrated the case where the coating film 2 for preventing tampering was used for the prefilled syringe 1, as for packaging containers, such as a foodstuff and a pharmaceutical, a cap is removed from a container main body, and a foreign material is mixed in an inside Then, the cap may be reattached to the container body. Therefore, in order to ensure the safety of the product, the tamper-resistant coating film 1 can be applied to the packaging container, and the tamper-proof coating film 1 can be externally installed at the boundary between the container body and the cap. .
  • the container body and the cap preferably have a circular shape in plan view so that the tamper-proof covering film 1 can be packaged (for example, a shape having no unevenness on the outer peripheral surface or a shape having small unevenness on the outer peripheral surface).

Abstract

Provided are: a tamperproof covering film with which evidence of seal-opening clearly remains whether a cap is rotated in either the forward or reverse direction with respect to a syringe body; and a container or prefilled syringe using said covering film. The covering film (2) is wrapped on the outer circumferential surface of a prefilled syringe so as to cover the boundary portion between the syringe body and the cap and has: multiple first incisions (14) provided at intervals along the circumferential direction; second incisions (15), which are provided for each of the first incisions (14) and form a specified inclined angle (θ) with respect to the first incision (14); and third incisions (16), which are provided so as to form a quadrilateral (F) with a first incision (14) and the two second incisions (15) on either side of the first incision (14). The quadrilateral (F) is a shape having a space (S) where two sides do not intersect at least at one of the two corners, of the four corners, that are at either end of the side (L4) opposite the first incision (14), or a shape having a discontinuity (C) on the side (L4) that is opposite the first incision (14).

Description

改ざん防止用の被覆フィルム、包装容器及びプレフィルドシリンジCover film, packaging container and prefilled syringe for preventing tampering
 本発明は、改ざん防止用の被覆フィルム、及び、当該被覆フィルムを備えた包装容器並びにプレフィルドシリンジに関する。 The present invention relates to a coating film for preventing falsification, a packaging container provided with the coating film, and a prefilled syringe.
 食品や医薬品などの包装容器は、容器本体からキャップが取り外され、内部に異物を混入された後、キャップが容器本体に再度取り付けられるおそれがある。よって、製品の安全性の確保のため、キャップが容器本体に再度取り付けられたか否かを確実に見分ける必要がある。そこで、従来から、容器本体とキャップとの境目部分に、改ざん防止機能を有する被覆フィルムが外装されている。改ざん防止用の被覆フィルムは、容器本体からキャップを取り外して開封すると、再びキャップで容器本体を閉じても開封した跡が目視で判断できるようになっている。この改ざん防止用の被覆フィルムは、食品や医薬品などの包装容器だけでなく、医療で用いられるシリンジにも用いられており、例えば、プレフィルドシリンジに用いられている。プレフィルドシリンジは、予め薬剤が封入された注射器である。このプレフィルドシリンジは、シリンジ本体と、シリンジ本体に着脱自在に取り付けられたキャップとを備えており、使用時において、キャップをシリンジ本体から取り外して注射針接続部を露出させた後、注射針接続部に注射針を取り付けることで、患者に薬剤を注射することができる。よって、アンプルから薬剤を吸い取る手間が必要なく、異物混入の可能性を低減できるうえ、投与する薬剤を間違える可能性が低いため、近年広く使用されている。被覆フィルムは、シリンジ本体とキャップとの境目部分を覆うようにして外装され、被覆フィルムには、周方向に沿って間隔をあけて複数の切れ込みが形成されている。キャップをシリンジ本体に対して回転させると、複数の切れ込みを介して被覆フィルムが容易に開封され、キャップをシリンジ本体から取り外すことができる。 For packaging containers for foods and pharmaceuticals, there is a possibility that the cap is removed from the container body, foreign matter is mixed inside, and then the cap is attached to the container body again. Therefore, in order to ensure the safety of the product, it is necessary to reliably determine whether or not the cap has been reattached to the container body. Therefore, conventionally, a coating film having a function of preventing falsification is externally provided at the boundary between the container body and the cap. When the cap is removed from the container main body and the cover film for preventing tampering is opened, even if the container main body is closed again with the cap, the opened mark can be visually determined. This coating film for preventing tampering is used not only for packaging containers for foods and pharmaceuticals, but also for syringes used in medicine, for example, prefilled syringes. A prefilled syringe is a syringe in which a medicine is previously enclosed. This prefilled syringe includes a syringe body and a cap that is detachably attached to the syringe body. In use, after removing the cap from the syringe body and exposing the injection needle connection portion, the injection needle connection portion A patient can be injected with a drug by attaching an injection needle to the patient. Therefore, there is no need to suck the drug from the ampoule, the possibility of foreign matter mixing can be reduced, and there is a low possibility that the drug to be administered is mistaken. The covering film is packaged so as to cover the boundary portion between the syringe body and the cap, and the covering film is formed with a plurality of cuts at intervals along the circumferential direction. When the cap is rotated with respect to the syringe body, the coating film is easily opened through the plurality of cuts, and the cap can be removed from the syringe body.
 また、被覆フィルムには、改ざん防止のために、例えば特許文献1では、被覆フィルムの複数の切れ込みに、切れ込みに対して傾斜する傾斜切れ込みが形成されており、この傾斜切れ込みにより、被覆フィルムが既に開封済みであるかどうかが明瞭に見分けられるようになっている。具体的には、傾斜切れ込みを、キャップの回転方向とは反対方向に向かって延びるとともに切れ込みに対して所定角度傾斜するように形成している。これにより、被覆フィルムを一旦開封すると、その後、キャップをシリンジ本体に再度取り付けても、傾斜切れ込みにより捲れが生じることで、被覆フィルムに開封した痕跡が明瞭に残る。よって、被覆フィルムが開封済みであるか否かを確実に見分けることができる。 In order to prevent falsification, for example, in Patent Document 1, a plurality of cuts in the cover film are formed with inclined cuts that are inclined with respect to the cuts. Whether or not it has been opened is clearly identified. Specifically, the inclined cut is formed so as to extend in a direction opposite to the rotation direction of the cap and to be inclined at a predetermined angle with respect to the cut. As a result, once the covering film is opened, even if the cap is attached to the syringe body again, the traces of the opening are clearly left on the covering film due to the tilted cut. Therefore, it can be reliably identified whether or not the covering film has been opened.
特許4960676号公報Japanese Patent No. 4960676
 特許文献1に記載の被覆フィルムは、特許文献1のプレフィルドシリンジのようなキャップがシリンジ本体に対して一方向にのみ回転可能なタイプのものに用いられる場合は、開封時に傾斜切れ込みにより捲れが生じて被覆フィルムに開封した痕跡が明瞭に残る。しかし、キャップがシリンジ本体に対して両方向に回転可能なタイプのプレフィルドシリンジやキャップをシリンジ本体に対して回転させることなく引き抜くタイプのプレフィルドシリンジなどに特許文献1に記載の被覆フィルムを用いると、傾斜切れ込みが延びる方向と同じ方向にキャップが回転された場合あるいはキャップが引き抜かれた場合には、開封した被覆フィルムに傾斜切れ込みによる捲れが生じにくく、よって、被覆フィルムが開封済みであるか否かの判別が困難になるという課題がある。 When the cap such as the prefilled syringe of Patent Document 1 is used for a type in which the cap can rotate only in one direction with respect to the syringe body, the coated film described in Patent Document 1 is wrinkled due to an inclined cut at the time of opening. As a result, traces of opening on the covering film remain clearly. However, when the coating film described in Patent Document 1 is used for a prefilled syringe of a type in which the cap can rotate in both directions with respect to the syringe body or a prefilled syringe of a type in which the cap is pulled out without rotating with respect to the syringe body, If the cap is rotated in the same direction as the direction in which the cut extends or if the cap is pulled out, it is difficult for the opened coated film to bend due to the inclined cut, so whether the coated film has been opened or not. There is a problem that discrimination becomes difficult.
 本発明は、上記課題を解決するためになされたものであり、キャップがシリンジ本体に対して一方向にのみ回転可能なタイプ及び両方向に回転可能なタイプのいずれのタイプのプレフィルドシリンジ、さらにキャップをシリンジ本体に対して回転させることなく引き抜くタイプのプレフィルドシリンジあっても、キャップを開封した痕跡が明瞭に残り、開封済みであるか否かを確実に見分けることができる改ざん防止用の被覆フィルムを提供することを目的とする。また、本発明は、プレフィルドシリンジ以外の包装容器についても、同様に、開封済みであるか否かを確実に見分けることができる改ざん防止用の被覆フィルムを提供することを目的とする。また、本発明は、当該改ざん防止用の被覆フィルムを用いたプレフィルドシリンジ及び包装容器を提供することを目的とする。 The present invention has been made in order to solve the above-mentioned problems, and the prefilled syringe of any type of a type in which the cap is rotatable only in one direction with respect to the syringe body and a type in which the cap is rotatable in both directions, and a cap are further provided. Even if there is a prefilled syringe that can be pulled out without rotating with respect to the syringe body, it provides a tamper-proof coating film that can clearly distinguish whether the cap has been opened and whether or not the cap has been opened. The purpose is to do. Another object of the present invention is to provide a falsification-preventing coating film that can reliably identify whether or not a packaging container other than a prefilled syringe has been opened. Another object of the present invention is to provide a prefilled syringe and a packaging container using the falsification-preventing coating film.
 本発明の上記目的は、改ざん防止用の被覆フィルムであって、長手方向に沿って間隔をあけて複数設けられる第1の切れ込みと、前記第1の切れ込みごとに設けられ、前記第1の切れ込みに対して所定の傾斜角度をなす第2の切れ込みと、前記第1の切れ込み及び前記第1の切れ込みを挟む2つの前記第2の切れ込みとで四角形を形成するように設けられる第3の切れ込みと、を備え、前記四角形は、4つの角のうち前記第1の切れ込みと対向する辺の両側の2つの角の少なくとも一方において2辺が交わらない形状、あるいは、前記第1の切れ込みと対向する辺に断続部を有する形状である被覆フィルムにより達成される。 The above-described object of the present invention is a falsification-preventing coating film, which is provided with a plurality of first cuts provided at intervals along the longitudinal direction, and is provided for each of the first cuts. A second notch having a predetermined inclination angle with respect to the first notch and the second notch sandwiching the first notch and a third notch provided to form a quadrangle The quadrilateral has a shape in which two sides do not intersect at least one of two corners on both sides of the side facing the first cut out of the four corners, or a side facing the first cut It is achieved by a coating film having a shape having an intermittent portion.
 上記構成の被覆フィルムにおいて、前記第3の切れ込みが前記第2の切れ込みと交差するように設けられることが好ましく、前記第3の切れ込みが1つおきの前記第2の切れ込みと交差するように設けられることがさらに好ましい。なお、第3の切れ込みは、隣接する2つの前記第2の切れ込みの間に設けられていてもよい。 In the coating film having the above-described structure, it is preferable that the third cut is provided so as to intersect with the second cut, and the third cut is provided so as to intersect every other second cut. More preferably, The third cut may be provided between two adjacent second cuts.
 また、前記第3の切れ込みが前記第1の切れ込みと平行に設けられることが好ましい。 Further, it is preferable that the third cut is provided in parallel with the first cut.
 また、前記第2の切れ込みは、前記第1の切れ込みと交点を有するように設けられることがさらに好ましい。 Further, it is more preferable that the second cut is provided so as to have an intersection with the first cut.
 また、前記第2の切れ込みの前記第1の切れ込みに対する前記傾斜角度が30度~150度であることが好ましく、45度であることがさらに好ましい。 Further, the inclination angle of the second cut with respect to the first cut is preferably 30 degrees to 150 degrees, and more preferably 45 degrees.
 また、前記第1の切れ込み、前記第2の切れ込み及び前記第3の切れ込みは、切目が連続する線状又は切目が不連続なミシン目状のいずれかで形成されていることがさらに好ましい。 Further, it is more preferable that the first cut, the second cut, and the third cut are formed in either a linear shape with continuous cuts or a perforated shape with discontinuous cuts.
 本発明の上記目的は、容器本体と、前記容器本体に着脱自在に取り付けられたキャップと、前記容器本体及び前記キャップの境目部分を覆うように外装される上記構成の被覆フィルムと、を備える包装容器によっても達成される。 The object of the present invention is a package comprising: a container body; a cap detachably attached to the container body; and a coating film having the above-described structure that is sheathed so as to cover the container body and a boundary portion of the cap. Also achieved by the container.
 本発明の上記目的は、シリンジ本体と、前記シリンジ本体に着脱自在に取り付けられたキャップと、前記シリンジ本体及び前記キャップの境目部分を覆うように外装される上記構成の被覆フィルムと、を備えるプレフィルドシリンジによっても達成される。 The object of the present invention is a prefilled comprising a syringe body, a cap detachably attached to the syringe body, and a coating film having the above-described structure that is sheathed so as to cover the boundary portion of the syringe body and the cap. Also achieved with a syringe.
 本発明によれば、キャップをシリンジ本体又は容器本体に対して正逆いずれの方向に回転させても、さらにキャップをシリンジ本体又は容器本体に対して回転させることなく引き抜いても、改ざん防止用の被覆フィルムに開封した痕跡が明瞭に残るので、開封済みであるか否かを確実に見分けることができることができる。よって、キャップを一方向にのみ回転可能なタイプ、キャップを両方向に回転可能なタイプ及びキャップを回転させることなく引き抜くタイプのいずれのタイプの包装容器及びプレフィルドシリンジあっても、キャップを取り外す動作を一旦行うと、改ざんの有無を良好に判断することができる。 According to the present invention, even if the cap is rotated in either the forward or reverse direction with respect to the syringe main body or the container main body, and even if the cap is pulled out without rotating with respect to the syringe main body or the container main body, Since the trace of opening is clearly left on the coating film, it can be surely discriminated whether or not it has been opened. Therefore, once the cap can be rotated only in one direction, the cap can be rotated in both directions, or the cap can be pulled out without rotating, any type of packaging container and prefilled syringe can be temporarily removed. By doing so, it is possible to satisfactorily determine whether or not tampering has occurred.
本発明の一実施形態に係る被覆フィルムの正面図である。It is a front view of the covering film concerning one embodiment of the present invention. 本発明の一実施形態に係る被覆フィルムを備えたプレフィルドシリンジの正面図である。It is a front view of the prefilled syringe provided with the coating film which concerns on one Embodiment of this invention. 図2のプレフィルドシリンジから被覆フィルムを取り除いた状態の正面図である。It is a front view of the state which removed the coating film from the prefilled syringe of FIG. 図3のプレフィルドシリンジを、キャップ、保護カバー及びシリンジ本体に分解した状態の正面図である。It is a front view of the state which decomposed | disassembled the prefilled syringe of FIG. 3 into the cap, the protective cover, and the syringe main body. 図1及び図2の被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film of FIG.1 and FIG.2. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention. 本発明の他の実施形態に係る被覆フィルムの要部を拡大して示す正面図である。It is a front view which expands and shows the principal part of the coating film which concerns on other embodiment of this invention.
 以下、本発明の実施形態について添付図面を参照して説明する。図1は、本発明の一実施形態に係る改ざん防止用被覆フィルム2(以下、単に「被覆フィルム2」という。)の外観を示している。また、図2は、本発明の一実施形態に係るプレフィルドシリンジ1の外観を示している。また、図3は、図2のプレフィルドシリンジ1から被覆フィルム2を取り除いた状態の外観を示しており、図4は、図3のプレフィルドシリンジ1を分解した状態の外観を示している。また、図5は、図1及び図2の被覆フィルム2の要部を拡大して示している。 Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. FIG. 1 shows the appearance of a tamper-resistant coating film 2 (hereinafter simply referred to as “coating film 2”) according to an embodiment of the present invention. Moreover, FIG. 2 has shown the external appearance of the prefilled syringe 1 which concerns on one Embodiment of this invention. Moreover, FIG. 3 has shown the external appearance of the state which removed the coating film 2 from the prefilled syringe 1 of FIG. 2, and FIG. 4 has shown the external appearance of the state which decomposed | disassembled the prefilled syringe 1 of FIG. Moreover, FIG. 5 has expanded and shown the principal part of the coating film 2 of FIG.1 and FIG.2.
 プレフィルドシリンジ1は、図2~図4に示すように、例えば合成樹脂製の筒状のシリンダ本体3と、シリンダ本体3に着脱可能に取り付けられるキャップ4とを備えている。シリンダ本体3の先端部には注射針接続部5が一体に設けられており、後端部はプランジャ挿入口6が開口している。注射針接続部5には保護カバー7が装着されている。プランジャ挿入口6にはプランジャ8が挿嵌されている。 2 to 4, the prefilled syringe 1 includes a cylindrical cylinder body 3 made of, for example, synthetic resin, and a cap 4 that is detachably attached to the cylinder body 3. A syringe needle connecting portion 5 is integrally provided at the distal end portion of the cylinder body 3, and a plunger insertion opening 6 is opened at the rear end portion. A protective cover 7 is attached to the injection needle connecting portion 5. A plunger 8 is inserted into the plunger insertion port 6.
 シリンダ本体3の内部には、本実施形態では、先端側から順に前側栓体9、中間栓体10及び後側栓体11がそれぞれシリンダ本体3の内周面に摺動可能に設けられており、前側栓体9及び中間栓体10の間に第1収容室12が密閉状態で形成され、中間栓体10及び後側栓体11の間に第2収容室13が密閉状態で形成されている。第1収容室12には、粉末状や固形状などの薬剤Mが収容され、第2収容室13には、薬剤Mの溶解液や分散液などの液体Lが収容されている。なお、薬剤Mは液状の薬剤であってもよく、その場合、液体Lは、第1収容室12に収容した薬剤Mと異なる薬液や、希釈用の蒸留水などであってよい。 In this embodiment, a front plug body 9, an intermediate plug body 10, and a rear plug body 11 are slidably provided on the inner peripheral surface of the cylinder body 3 in this embodiment from the front end side. The first storage chamber 12 is formed in a sealed state between the front plug body 9 and the intermediate plug body 10, and the second storage chamber 13 is formed in a sealed state between the intermediate plug body 10 and the rear plug body 11. Yes. The first storage chamber 12 stores a drug M such as powder or solid, and the second storage chamber 13 stores a liquid L such as a solution or dispersion of the drug M. The drug M may be a liquid drug. In this case, the liquid L may be a drug solution different from the drug M stored in the first storage chamber 12 or distilled water for dilution.
 キャップ4は、例えばゴム製であり、両端が開口した円筒状の筒状部40の一端に筒状部40よりも外形の大きい天面部41が一体に形成された形状を有している。筒状部40は、内部に保護カバー7及び注射針接続部5が収容可能であり、筒状部40内に注射針接続部5が嵌合している。このように、筒状部40の内周面が注射針接続部5の外周面と当接していることで、キャップ4がシリンジ本体3から取り外しにくくなっている。一方、筒状部40を注射針接続部5から引き抜くことで、キャップ4をシリンジ本体3から取り外せるが、キャップ4をシリンジ本体3に対して回転させながら引き抜くことで、シリンジ本体3から容易に取り外しやすくなっている。このように、キャップ4をシリンジ本体3に対して回転させても回転させなくても、シリンジ本体3から取り外すことができる。なお、被覆フィルム2には、開封時にキャップ4の回転方向を明示する方向Xが印刷されているが、方向Xとは反対方向にキャップ4を回転させても、シリンジ本体3から取り外すことが可能である。 The cap 4 is made of, for example, rubber, and has a shape in which a top surface portion 41 having an outer shape larger than the cylindrical portion 40 is integrally formed at one end of a cylindrical cylindrical portion 40 having both ends opened. The cylindrical portion 40 can accommodate the protective cover 7 and the injection needle connecting portion 5 inside, and the injection needle connecting portion 5 is fitted in the cylindrical portion 40. Thus, the cap 4 is difficult to be removed from the syringe body 3 because the inner peripheral surface of the tubular portion 40 is in contact with the outer peripheral surface of the injection needle connecting portion 5. On the other hand, the cap 4 can be removed from the syringe main body 3 by pulling out the cylindrical portion 40 from the injection needle connecting portion 5, but can be easily detached from the syringe main body 3 by pulling out the cap 4 while rotating with respect to the syringe main body 3. It has become easier. In this way, the cap 4 can be detached from the syringe body 3 with or without being rotated with respect to the syringe body 3. The cover film 2 is printed with a direction X that clearly indicates the rotation direction of the cap 4 when opened, but can be removed from the syringe body 3 by rotating the cap 4 in a direction opposite to the direction X. It is.
 被覆フィルム2は、図1及び図2に示すように、正面から視た外形が矩形状であり、本実施形態では、シリンジ本体3とキャップ4との境目部分Bを覆うようにしてプレフィルドシリンジ1の外周面に巻き付けられ、当該境目部分Bを包装している。被覆フィルム2としては、熱収縮性を有するシュリンクフィルムが好適に用いられる。シュリンクフィルムは、例えば、ポリエチレン、ポリプロピレン、ポリエチレンテレフタレート、ポリ塩化ビニルなどのフィルムを挙げることができる。なかでも、開封性、収縮性、環境適性などを考慮すると、ポリエチレンフィルムが好ましい。被覆フィルム2の裏面には、接着剤又は粘着剤の層が形成されており、被覆フィルム2の裏面がシリンジ本体3及びキャップ4を跨ぐようにしてプレフィルドシリンジ1の外周面に貼り付けられている。なお、被覆フィルム2は、シュリンクフィルム以外にも、通常、包装のために使用されるフィルムであれば特に限定することなく用いることができる。 As shown in FIGS. 1 and 2, the coating film 2 has a rectangular outer shape when viewed from the front, and in this embodiment, the prefilled syringe 1 covers the boundary portion B between the syringe body 3 and the cap 4. The boundary part B is wrapped around the outer peripheral surface. As the covering film 2, a shrink film having heat shrinkability is suitably used. Examples of the shrink film include films of polyethylene, polypropylene, polyethylene terephthalate, polyvinyl chloride, and the like. Of these, a polyethylene film is preferable in consideration of openability, shrinkage, environmental suitability, and the like. An adhesive or pressure-sensitive adhesive layer is formed on the back surface of the covering film 2, and the back surface of the covering film 2 is attached to the outer peripheral surface of the prefilled syringe 1 so as to straddle the syringe body 3 and the cap 4. . In addition to the shrink film, the covering film 2 can be used without particular limitation as long as it is a film usually used for packaging.
 被覆フィルム2には、シリンジ本体3及びキャップ4の境目部分Bの近傍に、周方向(図1では長手方向)に延びる第1の切れ込み14が、周方向(図1では長手方向)に沿って間隔S1をあけて複数設けられている。キャップ4をシリンジ本体3に対して回転させずに引き抜いた場合、又は、キャップ4をシリンジ本体3に対して正逆いずれの方向に回転させながら引き抜いた場合のいずれであっても、複数の第1の切れ込み14を介して被覆フィルム2が容易に破断されて開封される。これにより、キャップ4をシリンジ本体3から取り外すことができる。 The coating film 2 has a first cut 14 extending in the circumferential direction (longitudinal direction in FIG. 1) in the vicinity of the boundary portion B between the syringe body 3 and the cap 4 along the circumferential direction (longitudinal direction in FIG. 1). A plurality is provided with an interval S1. Whether the cap 4 is pulled out without rotating with respect to the syringe body 3 or when the cap 4 is pulled out while rotating in the forward or reverse direction with respect to the syringe body 3, The covering film 2 is easily broken and opened through one cut 14. Thereby, the cap 4 can be removed from the syringe body 3.
 また、被覆フィルム2には、図5に示すように、第1の切れ込み14ごとに、それぞれ1つの第2の切れ込み15が設けられている。第2の切れ込み15は、第1の切れ込み14に対して所定の傾斜角度θで傾斜するように設けられている。第2の切れ込み15と第1の切れ込み14とがなす傾斜角度θは特に限定されるものではない。よって、第2の切れ込み15は、周方向の正逆いずれの方向に向かって延びながら第1の切れ込み14に対して傾斜していてもよいし、第1の切れ込み14に対して90度の角度をなしていてもよいが、前記傾斜角度θは、30度~150度が好ましく、30度~135度がさらに好ましく、45度あるいは135度がさらに好ましく、図5の例では、傾斜角度θが45度である。傾斜角度θが30度~150度であると、詳細は後述するが、キャップ4をシリンジ本体3から取り外して被覆フィルム2を開封する際に、キャップ4をシリンジ本体3に対して正逆いずれの方向に回転させながらあるいは回転させずに引き抜いた場合、開封後の被覆フィルム2に四角形Fの捲れが生じるが、四角形Fの面積をある程度大きくとることができるので、開封した痕跡が明瞭に残るからである。また、第2の切れ込み15は、図5の例では、第1の切れ込み14と交点を有するように形成されており、第1の切れ込み14の端部から延びて、第1の切れ込み14及び第2の切れ込み15でL字をなしている。 Further, as shown in FIG. 5, the coating film 2 is provided with one second notch 15 for each first notch 14. The second cut 15 is provided so as to be inclined at a predetermined inclination angle θ with respect to the first cut 14. The inclination angle θ formed by the second cut 15 and the first cut 14 is not particularly limited. Therefore, the second cut 15 may be inclined with respect to the first cut 14 while extending in either the forward or reverse direction of the circumferential direction, or an angle of 90 degrees with respect to the first cut 14. However, the inclination angle θ is preferably 30 ° to 150 °, more preferably 30 ° to 135 °, further preferably 45 ° or 135 °. In the example of FIG. 45 degrees. As will be described in detail later when the inclination angle θ is 30 ° to 150 °, when the cap 4 is detached from the syringe body 3 and the covering film 2 is opened, the cap 4 is either forward or reverse with respect to the syringe body 3. If the film is pulled out while rotating in the direction or without rotating, the covering film 2 after opening will bend the square F, but since the area of the square F can be increased to some extent, the opened trace remains clearly. It is. In the example of FIG. 5, the second notch 15 is formed so as to have an intersection with the first notch 14, and extends from the end of the first notch 14. An L-shape is formed by two cuts 15.
 さらに、被覆フィルム2には、所定位置に、周方向に延びる第3の切れ込み16が複数設けられている。この第3の切れ込み16は、第1の切れ込み14及び当該第1の切れ込み14を挟む2つの第2の切れ込み15とで、四角形Fを形成する、つまり、第1の切れ込み14、隣接する2つの第2の切れ込み15及び少なくとも1つの第3の切れ込み16を4つの辺L1~L4として囲まれた図形が四角形Fとなるように、被覆フィルム2に設けられている。この四角形Fは、4つの角のうち第1の切れ込み14と対向する辺L4の両側の2つの角の少なくとも一方の角において2辺(L2,L4又はL3,L4)が交わらずに間隔S2をあけた形状、あるいは、第1の切れ込み14と対向する辺L4に断続部C(図6に示す)を有する形状をしており、厳密にいえば四角形ではないが本明細書では四角形と称している。図5の例では、周方向に並ぶ複数の第2の切れ込み15のうち、1つおきの第2の切れ込み15に対して当該第2の切れ込み15と交差するように第3の切れ込み16が設けられている。よって、第1の切れ込み14を挟む2つの第2の切れ込み15のうちのいずれか一方の第2の切れ込み15と、第3の切れ込み16との間に間隔S2が設けられている。なお、第1の切れ込み14と、これを挟む2つの第2の切れ込み15のうちの一方の第2の切れ込み15との間にも間隔S1を有している。よって、図5の例では、2つの角において交点を有していない四角形Fが形成されている。また、図5の例では、第3の切れ込み16は、第1の切れ込み14と平行に設けられており、四角形Fは平行四辺形である。第3の切れ込み16が第1の切れ込み14と平行である場合には、四角形Fの面積をある程度大きくとることができるので、キャップ4をシリンジ本体3から取り外して被覆フィルム2を開封した際に痕跡が明瞭に残ることから好ましい。なお、第3の切れ込み16は、必ずしも第1の切れ込み14と平行である必要はなく、四角形Fの面積をある程度大きくとることができるのであれば、第3の切れ込み16が第1の切れ込み14に対して傾斜するように形成されていてもよい。 Furthermore, the coating film 2 is provided with a plurality of third cuts 16 extending in the circumferential direction at predetermined positions. This third notch 16 forms a square F with the first notch 14 and the two second notches 15 sandwiching the first notch 14, that is, the first notch 14 and the two adjacent notches The cover film 2 is provided so that the figure surrounded by the four sides L1 to L4 of the second cut 15 and at least one third cut 16 is a square F. This quadrangle F has an interval S2 in which at least one of the two corners on both sides of the side L4 facing the first notch 14 does not intersect with each other (L2, L4 or L3, L4). It has an open shape or a shape having an interrupted portion C (shown in FIG. 6) on the side L4 facing the first cut 14 and is not a square in the strict sense, but is called a square in this specification. Yes. In the example of FIG. 5, among the plurality of second cuts 15 arranged in the circumferential direction, the third cut 16 is provided so as to intersect with the second cut 15 with respect to every second cut 15. It has been. Therefore, the interval S <b> 2 is provided between the second notch 15 of the two second notches 15 sandwiching the first notch 14 and the third notch 16. Note that there is also a space S1 between the first cut 14 and one of the two second cuts 15 sandwiching the first cut 14. Therefore, in the example of FIG. 5, a square F that does not have an intersection at two corners is formed. In the example of FIG. 5, the third cut 16 is provided in parallel with the first cut 14, and the quadrangle F is a parallelogram. When the third cut 16 is parallel to the first cut 14, the area of the quadrangle F can be increased to some extent, so that when the cap 4 is removed from the syringe body 3 and the covering film 2 is opened, there are traces. Is preferable because it remains clear. The third cut 16 is not necessarily parallel to the first cut 14. If the area of the quadrangle F can be increased to some extent, the third cut 16 becomes the first cut 14. It may be formed so as to be inclined with respect to.
 この図5の例において、第3の切れ込み16と、第3の切れ込み16と交差していない第2の切れ込み15との間の間隔S2は、隣接する第1の切れ込み14の間隔S1と比べて大きいことが好ましく、間隔S1に対する間隔S2の長さ(周方向の長さ)比で3以上(S2/S1≧3)であることがさらに好ましい。間隔S1が小さいと、キャップ4をシリンジ本体3から取り外して被覆フィルム2を開封する際に、各第1の切れ込み14により周方向に連続して被覆フィルム2が破断され、被覆フィルム2をきれいに開封しやすくなる。一方で、間隔S2が大きいと、各第1の切れ目14において被覆フィルム2が破断されるとき、四角形Fが間隔S2を介して被覆フィルム2に残って捲れ上がりやすくなる。 In the example of FIG. 5, the distance S <b> 2 between the third notch 16 and the second notch 15 not intersecting with the third notch 16 is compared with the distance S <b> 1 between the adjacent first notches 14. It is preferably large, and more preferably 3 or more (S2 / S1 ≧ 3) in the ratio of the length of the interval S2 to the interval S1 (the length in the circumferential direction). If the interval S1 is small, when the cap 4 is removed from the syringe body 3 and the covering film 2 is opened, the covering film 2 is continuously broken in the circumferential direction by the first cuts 14 and the covering film 2 is opened cleanly. It becomes easy to do. On the other hand, when the interval S2 is large, when the covering film 2 is broken at each first cut 14, the square F remains on the covering film 2 via the interval S2 and tends to be rolled up.
 この図5の例の被覆フィルム2について好ましい寸法を例示すると、被覆フィルム2の長手方向の長さが57mm、短手方向の長さが22mmとすれば、第1の切れ込み14の長さを2.4mm、隣接する第1の切れ込み14の間隔S1を0.6mm、とすることができる。また、第2の切れ込み15の第1の切れ込み14に対する傾斜角度θを45度とし、第3の切れ込み16の長さを3.0mm、互いに交差していない第3の切れ込み16及び第2の切れ込み15の間の間隔S2を1.0mmもしくは2.0mm、とすることができる。また、第2の切れ込み15の長さを4.0mmとすることができる。 The preferable dimensions of the covering film 2 in the example of FIG. 5 are as follows. If the length of the covering film 2 in the longitudinal direction is 57 mm and the length in the short direction is 22 mm, the length of the first cut 14 is 2 4 mm, and the interval S1 between the adjacent first cuts 14 can be 0.6 mm. Further, the inclination angle θ of the second cut 15 with respect to the first cut 14 is 45 degrees, the length of the third cut 16 is 3.0 mm, and the third cut 16 and the second cut that do not intersect each other. The interval S2 between 15 can be 1.0 mm or 2.0 mm. Further, the length of the second cut 15 can be set to 4.0 mm.
 第3の切れ込み16は、図5の例では、1つおきの第2の切れ込み15に当該第2の切れ込み15と交差するように設けられているが、図6に示すように、周方向に並ぶ各第2の切れ込み15に当該第2の切れ込み15と交差するように設けられていてもよい。この図6の例では、隣接する2つの第3の切れ込み16の一部同士で四角形Fの1辺L4を構成しており、辺L4には、2つの第3の切れ込み16の間隔からなる断続部Cが形成されている。また、第1の切れ込み14とこれを挟む2つの第2の切れ込み15のうちの一方の第2の切れ込み15との間に間隔S1を有しており、図6の例では、断続部C及び間隔S1を有する四角形Fが形成されている。この図6の例においても、図5の例と同様に、断続部Cは間隔S1と比べて大きいことが好ましく、間隔S1に対する断続部Cの長さ(周方向の長さ)比で3以上(C/S1≧3)であることがさらに好ましい。 In the example of FIG. 5, the third cuts 16 are provided in every other second cut 15 so as to intersect the second cuts 15, but as shown in FIG. Each second notch 15 arranged may be provided so as to intersect with the second notch 15. In the example of FIG. 6, one side L <b> 4 of the quadrangle F is formed by a part of two adjacent third cuts 16, and the side L <b> 4 is intermittently formed by an interval between the two third cuts 16. Part C is formed. In addition, there is an interval S1 between the first notch 14 and one of the two second notches 15 sandwiching the first notch 14, and in the example of FIG. A square F having an interval S1 is formed. In the example of FIG. 6 as well, as in the example of FIG. 5, the interrupted portion C is preferably larger than the interval S1, and the length (circumferential length) ratio of the interrupted portion C to the interval S1 is 3 or more. More preferably, (C / S1 ≧ 3).
 また、第3の切れ込み16は、図7に示すように、第2の切れ込み15と交差することなく、隣接する2つの第2の切れ込み15の間に設けられていてもよい。この図7の例では、第1の切れ込み14とこれを挟む2つの第2の切れ込み15のうちの一方の第2の切れ込み15との間に間隔S1を、及び、第3の切れ込み16と前記2つの第2の切れ込み15の両方との間にそれぞれ間隔S2を有する四角形Fが形成されている。この図7の例においても、図5の例と同様に、間隔S2は間隔S1と比べて大きいことが好ましく、間隔S1に対する間隔S2の長さ(周方向の長さ)比で3以上(C/S1≧3)であることがさらに好ましい。 Further, as shown in FIG. 7, the third cut 16 may be provided between the two adjacent second cuts 15 without intersecting the second cut 15. In the example of FIG. 7, an interval S1 is provided between the first cut 14 and one of the two second cuts 15 sandwiching the first cut 14, and the third cut 16 is A square F having an interval S2 is formed between both of the two second cuts 15. In the example of FIG. 7, as in the example of FIG. 5, the interval S2 is preferably larger than the interval S1, and the length (circumferential length) ratio of the interval S2 to the interval S1 is 3 or more (C More preferably, / S1 ≧ 3).
 このように、第3の切れ込み16は、必ずしも1つおきの第2の切れ込み15に設けられる必要はないが、図5に示すように、1つおきの第2の切れ込み15に設けられていると、図6及び図7の例と比べて、複数の第3の切れ込み16が離間間隔を大きくまばらに被覆フィルム2に配置されるようになる。複数の第3の切れ込み16が離間間隔を小さく密に被覆フィルム2に配置されていると、キャップ4をシリンジ本体3に対して回転させて被覆フィルム2を開封させる際に、シリンジ本体3及びキャップ4の境目部分Bの近傍の第1の切れ込み14ではなく、第3の切れ込み16で被覆フィルム2が破断して開封する可能性がある。そのため、好ましくは第1の切れ込み14で被覆フィルム2を破断させて開封させるとの観点から、第3の切れ込み16は、1つおきの第2の切れ込み15に対して設けられるのが好ましい。 As described above, the third cuts 16 are not necessarily provided in every other second cut 15, but are provided in every other second cut 15 as shown in FIG. Compared with the examples of FIGS. 6 and 7, the plurality of third cuts 16 are arranged in the covering film 2 with a large separation interval. When the plurality of third cuts 16 are closely arranged in the coating film 2 with a small separation interval, the syringe body 3 and the cap are opened when the cap 4 is rotated with respect to the syringe body 3 to open the coating film 2. There is a possibility that the covering film 2 is broken and opened at the third cut 16 instead of the first cut 14 in the vicinity of the boundary portion B of the fourth line. Therefore, it is preferable that the third cuts 16 are provided for every other second cut 15 from the viewpoint of breaking the cover film 2 with the first cuts 14 and opening them.
 また、第2の切れ込み15と第1の切れ込み14との傾斜角度θは、図5の例では90度より小さくなっているが、図8に示すように傾斜角度θは90度であってもよく、また、図9に示すように傾斜角度θは90度を越えていてもよい。なお、図6及び図7の例においても、図示は省略するが、第2の切れ込み15と第1の切れ込み14との傾斜角度θが、90度であってもよいし、90度を越えていてもよく、適宜設定できる。 In addition, the inclination angle θ between the second notch 15 and the first notch 14 is smaller than 90 degrees in the example of FIG. 5, but even if the inclination angle θ is 90 degrees as shown in FIG. Moreover, as shown in FIG. 9, the inclination angle θ may exceed 90 degrees. In the examples of FIGS. 6 and 7, although not shown, the inclination angle θ between the second cut 15 and the first cut 14 may be 90 degrees or exceeds 90 degrees. It may be set as appropriate.
 また、第2の切れ込み15は、図5~図7の例では、第1の切れ込み14と交点を有するように交差しているが、必ずしも交差している必要はなく、図10~図12に示すように、第1の切れ込み14とは交点を有さずに第1の切れ込み14から間隔S3をあけるように設けられていてもよい。この図10~図12の例では、4つの辺L1~L4を構成する各切れ込み14~16で囲まれる四角形Fは、図5~図7の例と比べると、第1の切れ込み14とこれを挟む2つの第2の切れ込み15のいずれの第2の切れ込み15との間に、間隔S1,S3を有するように形成される。なお、図10~図12の例においても、図示は省略するが、第2の切れ込み15と第1の切れ込み14との傾斜角度θは、90度であってもよいし、90度を越えていてもよく、適宜設定できる。 Further, in the example of FIGS. 5 to 7, the second notch 15 intersects with the first notch 14 so as to have an intersection, but it is not always necessary to intersect. As shown, the first notch 14 may be provided so as to leave an interval S3 from the first notch 14 without having an intersection. In the example of FIGS. 10 to 12, the square F surrounded by the notches 14 to 16 constituting the four sides L1 to L4 is compared with the first notch 14 and this as compared to the examples of FIGS. Between the two second cuts 15 between the two second cuts 15 sandwiched, the gaps S1 and S3 are formed. In the examples of FIGS. 10 to 12, although not shown, the inclination angle θ between the second notch 15 and the first notch 14 may be 90 degrees or exceeds 90 degrees. It may be set as appropriate.
 上記した例のように、被覆フィルム2に、第1の切れ込み14を1辺L1とし、第2の切れ込み15及び第3の切れ込み16を残りの3辺L2~L4とした四角形Fを周方向に並ぶように複数形成することで、詳細は後述するが、キャップ4をシリンジ本体3から取り外して被覆フィルム2を開封する際に、キャップ4をシリンジ本体3に対して正逆いずれの方向に回転させながら引き抜いても、また、回転させずに引き抜いても、開封後の被覆フィルム2に捲れが生じ、開封した痕跡が明瞭に残る。これにより、被覆フィルム2が開封済みであるか否かを確実に見分けることができ、キャップ4がリキャップされたものであるかを判別できる。 As in the example described above, the rectangular F having the first cut 14 as one side L1 and the second cut 15 and the third cut 16 as the remaining three sides L2 to L4 in the coating film 2 in the circumferential direction. As will be described in detail later, the cap 4 is rotated in either the forward or reverse direction with respect to the syringe body 3 when the cover film 2 is opened by removing the cap 4 from the syringe body 3. Even if the film is pulled out or pulled out without rotating, the coated film 2 after opening is wrinkled, and the opened trace remains clearly. Thereby, it can be discriminate | determined reliably whether the coating film 2 has been opened, and it can be discriminate | determined whether the cap 4 is recapped.
 なお、図13~図15に示すように、第1~第3の切れ込み14~16以外の第4の切れ込み17を被覆フィルム2に設けてもよい。例えば図13では、図10の例の各切れ込み14~16に対して、第3の切れ込み16と並行配置されるとともに第2の切れ込み16と交差するように、周方向に延びる第4の切れ込み17がさらに設けられている。また、図14では、図12の例の各切れ込み14~16に対して、第3の切れ込み16と並行配置されるとともに第2の切れ込み16と交差しないように、周方向に延びる第4の切れ込み17がさらに設けられている。また、図15では、図5の例の各切れ込み14~16に対して、第1の切れ込み14及び第2の切れ込み15とでZ字をなすように、周方向に延びる第4の切れ込み17がさらに設けられている。なお、上記したいずれの例についても、第1~第3の切れ込み14~16以外の第4の切れ込み17を同様に設けることができるのは言うまでもない。また、第4の切れ込み17は2本以上設けることもできる。また、第4の切れ込み17は、周方向に延びている必要はなく、第1~第3の切れ込み14~16による四角形Fの形成を阻害しない限り種々の態様で設けることができる。 Note that, as shown in FIGS. 13 to 15, a fourth cut 17 other than the first to third cuts 14 to 16 may be provided in the coating film 2. For example, in FIG. 13, for each of the incisions 14 to 16 in the example of FIG. 10, a fourth notch 17 that is arranged in parallel with the third incision 16 and extends in the circumferential direction so as to intersect the second incision 16. Is further provided. Further, in FIG. 14, a fourth cut extending in the circumferential direction is arranged in parallel with the third cut 16 and does not intersect the second cut 16 with respect to the respective cuts 14 to 16 in the example of FIG. 17 is further provided. Further, in FIG. 15, a fourth notch 17 extending in the circumferential direction is formed so that the first notch 14 and the second notch 15 form a Z shape with respect to the notches 14 to 16 in the example of FIG. Furthermore, it is provided. In any of the above examples, it goes without saying that the fourth cut 17 other than the first to third cuts 14 to 16 can be provided in the same manner. Two or more fourth notches 17 may be provided. The fourth cut 17 does not need to extend in the circumferential direction, and can be provided in various modes as long as the formation of the square F by the first to third cuts 14 to 16 is not hindered.
 上記構成のプレフィルドシリンジ1においては、使用者が、キャップ4をシリンジ本体3に対して回転させると、また、回転させずに引き抜くと、キャップ4及びシリンジ本体3を被覆している被覆フィルム2が、複数の第1の切れ目14において破断することで開封される。その際、被覆フィルム2には、周方向に配置される各第1の切れ込み14に対応して、第1~第3の切れ込み14~16により囲まれる四角形Fが存在しており、各第1の切れ目14において被覆フィルム2が破断されると、この四角形Fは、第1の切れ込み14と対向する辺L4の両側の少なくともいずれか一方の角(間隔S2)あるいは辺L4の断続部Cを残して捲れ上がる。よって、被覆フィルム2に開封の痕跡が明確に残ることになる。この被覆フィルム2の開封時における四角形Fの捲れは、キャップ4をシリンジ本体3に対してX方向に回転させた場合だけでなく、X方向とは逆方向にキャップ4を回転させた場合においても、また、回転させずに引き抜いた場合においても、それぞれ生じるので、キャップ4をシリンジ本体3から一旦取り外して被覆フィルム2を開封すれば、キャップ4がリキャップされたか否かを確実に見分けることができる。また、この被覆フィルム2の開封時における四角形Fの捲れは、先行技術文献1の傾斜切れ込みによる捲れよりも、捲れが大きいため、開封した痕跡もより明瞭となる。 In the prefilled syringe 1 having the above-described configuration, when the user rotates the cap 4 with respect to the syringe main body 3, or when the user pulls out without rotating, the covering film 2 covering the cap 4 and the syringe main body 3 is formed. Then, it is opened by breaking at the plurality of first cuts 14. At that time, the covering film 2 has a square F surrounded by the first to third cuts 14 to 16 corresponding to the first cuts 14 arranged in the circumferential direction. When the covering film 2 is broken at the cut line 14, the square F leaves at least one corner (interval S <b> 2) on both sides of the side L <b> 4 facing the first cut 14 or the intermittent part C of the side L <b> 4. And drown. Therefore, a trace of opening remains clearly on the covering film 2. When the cover film 2 is opened, the square F is bent not only when the cap 4 is rotated in the X direction with respect to the syringe body 3 but also when the cap 4 is rotated in the direction opposite to the X direction. In addition, even when the cap 4 is pulled out without being rotated, it occurs in each case. Therefore, once the cap 4 is removed from the syringe body 3 and the covering film 2 is opened, it is possible to reliably determine whether or not the cap 4 has been recapped. . Moreover, since the curving of the square F at the time of opening of the covering film 2 is larger than the curling due to the inclined cut in the prior art document 1, the opened trace becomes clearer.
 また、第2の切れ目15が、例えば図5の例のように、被覆フィルム2にキャップ4の回転方向として表示されている方向Xに向かって延びるように傾斜していると、上記した被覆フィルム2の開封時にキャップ4をX方向に回転させた場合、四角形Fの捲れを発生させやすくできるので、被覆フィルム2の開封を容易かつ確実に行うことができる。 Moreover, when the 2nd cut | interruption 15 inclines so that it may extend toward the direction X currently displayed as the rotation direction of the cap 4 on the coating film 2 like the example of FIG. When the cap 4 is rotated in the X direction at the time of opening 2, the quadrilateral F can be easily distorted, so that the covering film 2 can be opened easily and reliably.
 また、例えば図5の例のように、周方向に並ぶ複数の第2の切れ込み15のうちの1つおきの第2の切れ込み15に第3の切れ込み16が設けられていると、複数の第3の切れ込み16は離間間隔を大きくあけて被覆フィルム2に配置される。よって、キャップ4をシリンジ本体3に対して回転させて被覆フィルム2を開封させる際、第3の切れ込み16ではなく、シリンジ本体3及びキャップ4の境目部分Bの近傍の第1の切れ込み14で被覆フィルム2を確実に破断させることができるので、被覆フィルム2の開封後、キャップ4をシリンジ本体3から取り外しやすくなる。 Further, for example, as in the example of FIG. 5, when the third notch 16 is provided in every other second notch 15 among the plurality of second notches 15 arranged in the circumferential direction, The three cuts 16 are arranged in the covering film 2 with a large separation interval. Therefore, when the cap 4 is rotated with respect to the syringe body 3 and the covering film 2 is opened, the first notch 14 in the vicinity of the boundary portion B of the syringe body 3 and the cap 4 is covered instead of the third notch 16. Since the film 2 can be reliably broken, the cap 4 can be easily detached from the syringe body 3 after the covering film 2 is opened.
 以上、本発明の一実施形態について説明したが、本発明は上記実施形態に限定されるものではなく、その趣旨を逸脱しない限りにおいて、種々の変更が可能である。例えば、上記実施形態では、各切れ込み14~16は、切目が連続する線状に形成されているが、切目が不連続に並ぶミシン目状で形成されていてもよい。つまりは、各切れ込み14~16は、1つの連続して延びる切目からなっていてもよいし、複数の断続する切目からなっていてもよい。 Although one embodiment of the present invention has been described above, the present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention. For example, in the above-described embodiment, each of the cuts 14 to 16 is formed in a linear shape with continuous cuts, but may be formed in a perforated form in which the cuts are discontinuously arranged. In other words, each of the cuts 14 to 16 may consist of one continuous extending cut or a plurality of intermittent cuts.
 なお、上記ミシン目状は、均一な長さの切目が不連続で並ぶ態様の他、不均一な長さの切目が不連続で並ぶ態様であってもよい。また、図16に示す第2の切れ込み15及び第3の切れ込み16のように、2つの切目が間隔をあけて設けられた切れ込みについても、ミシン目状に形成されていると言うことができる。図16では、第2の切れ込み15と第3の切れ込み16とが交差する部分(交点)に、切目を有さない部分Bが設けられており、第2の切れ込み15及び第3の切れ込み16は、交点で途切れた形状となっている。なお、図16の例において、2つの切目の間隔としては0.1mm~1mm程度とすることができる。 The perforated shape may be a mode in which cuts having a uniform length are arranged in a discontinuous manner, or a mode in which cuts having a non-uniform length are arranged in a discontinuous manner. Moreover, it can be said that the notch in which the two notches are provided with a space therebetween as in the second notch 15 and the third notch 16 shown in FIG. 16 is formed in a perforated shape. In FIG. 16, a portion B having no cut is provided at a portion (intersection) where the second cut 15 and the third cut 16 intersect, and the second cut 15 and the third cut 16 are The shape is broken at the intersection. In the example of FIG. 16, the interval between the two cuts can be about 0.1 mm to 1 mm.
 この図16の例では、図10に示す例と同様に、第2の切れ込み15は、第1の切れ込み14とは交点を有さずに第1の切れ込み14から間隔S3をあけるように設けられている。この図16の例のように、第2の切れ込み15と第3の切れ込み16とが交差する部分(交点)に切目を有さない部分Bを設けるとともに、第2の切れ込み15が第1の切れ込み14と交点を有さずに間隔S3をあけるように設けられていると、被覆フィルム2を熱収縮により、プレフィルドシリンジ1の外周面に巻き付けた際に、各切れ込み14~16において被覆フィルム2が開くことなく綺麗に巻き付けることができる。 In the example of FIG. 16, as in the example shown in FIG. 10, the second notch 15 is provided so as to leave an interval S3 from the first notch 14 without having an intersection with the first notch 14. ing. As in the example of FIG. 16, a portion B having no cut is provided at a portion (intersection) where the second cut 15 and the third cut 16 intersect, and the second cut 15 is the first cut. 14 is provided so as to leave an interval S3 without having an intersection with the coating film 2, when the coating film 2 is wound around the outer peripheral surface of the prefilled syringe 1 by heat shrinkage, the coating film 2 is formed at each of the notches 14-16. It can be wrapped neatly without opening.
 なお、図16の例は、図10の例に対して、第2の切れ込み15及び第3の切れ込み16を交点で途切れた形状としているが、図5、図6、図8、図9、図11、図13の例などにおいても、図示は省略するが、第2の切れ込み15及び第3の切れ込み16を交点で途切れた形状としてもよい。 In addition, although the example of FIG. 16 is made into the shape which interrupted the 2nd notch 15 and the 3rd notch 16 at the intersection with respect to the example of FIG. 10, FIG.5, FIG.6, FIG.8, FIG. 11 and 13, the second cut 15 and the third cut 16 may be cut off at the intersections.
 また、例えば図5~図9のように、第2の切れ込み15が第1の切れ込み14と交差している例では、第1の切れ込み14の端部で交差しているが、第1の切れ込み14の中間部で交差する構成であってもよい。また、第2の切れ込み15は、第1の切れ込み14との交差部位で終端しているが、第1の切れ込み14を横切る構成であってもよい。なお、例えば図10~図12のように、第2の切れ込み15が第1の切れ込み14と交差していない例であっても、隣り合う2つの第1の切れ込み14の間を第2の切れ込み15が突き抜ける構成であってもよい。 Further, in the example in which the second cut 15 intersects the first cut 14 as shown in FIGS. 5 to 9, for example, the first cut 14 crosses at the end of the first cut 14. The structure which cross | intersects in the intermediate part of 14 may be sufficient. Moreover, although the 2nd notch 15 is terminated in the cross | intersection site | part with the 1st notch 14, the structure which crosses the 1st notch 14 may be sufficient. Note that, for example, as shown in FIGS. 10 to 12, even if the second notch 15 does not intersect the first notch 14, the second notch between the two adjacent first notches 14 is used. The structure which 15 penetrates may be sufficient.
 また、上記実施形態では、改ざん防止用被覆フィルム2をプレフィルドシリンジ1に用いた場合を説明しているが、食品や医薬品などの包装容器も、容器本体からキャップが取り外され、内部に異物を混入された後、キャップが容器本体に再度取り付けられるおそれがある。よって、製品の安全性の確保のため、包装容器においても改ざん防止用被覆フィルム1を適用することができ、容器本体とキャップとの境目部分に、改ざん防止用被覆フィルム1を外装することができる。なお、容器本体及びキャップは、その外形が平面視円形状で改ざん防止用被覆フィルム1を外装できる形状(例えば、外周面に凹凸がない形状、あるいは、外周面に小さな凹凸がある形状などが好ましいが、これに限られるものではない)であれば、いかなるものであっても構わない。また、キャップが容器本体に対して一方向にのみ回転可能なタイプ及び両方向に回転可能なタイプのいずれのタイプの包装容器、さらにキャップを容器本体に対して回転させることなく引き抜くタイプの包装容器あっても構わない。 Moreover, although the said embodiment demonstrated the case where the coating film 2 for preventing tampering was used for the prefilled syringe 1, as for packaging containers, such as a foodstuff and a pharmaceutical, a cap is removed from a container main body, and a foreign material is mixed in an inside Then, the cap may be reattached to the container body. Therefore, in order to ensure the safety of the product, the tamper-resistant coating film 1 can be applied to the packaging container, and the tamper-proof coating film 1 can be externally installed at the boundary between the container body and the cap. . In addition, the container body and the cap preferably have a circular shape in plan view so that the tamper-proof covering film 1 can be packaged (for example, a shape having no unevenness on the outer peripheral surface or a shape having small unevenness on the outer peripheral surface). However, it is not limited to this). In addition, there is a packaging container of a type in which the cap can be rotated only in one direction with respect to the container body and a type in which the cap can be rotated in both directions. It doesn't matter.
 1  プレフィルドシリンジ
 2  被覆フィルム
 3  シリンジ本体
 4  キャップ
 14 第1の切れ込み
 15 第2の切れ込み
 16 第3の切れ込み
 F  四角形
 S2 間隔
 C  断続部
 θ  傾斜角度
DESCRIPTION OF SYMBOLS 1 Prefilled syringe 2 Coating | coated film 3 Syringe main body 4 Cap 14 1st notch 15 2nd notch 16 3rd notch F Square S2 space | interval C Intermittent part θ Inclination angle

Claims (11)

  1.  改ざん防止用の被覆フィルムであって、
     長手方向に沿って間隔をあけて複数設けられる第1の切れ込みと、
     前記第1の切れ込みごとに設けられ、前記第1の切れ込みに対して所定の傾斜角度をなす第2の切れ込みと、
     前記第1の切れ込み及び前記第1の切れ込みを挟む2つの前記第2の切れ込みとで四角形を形成するように設けられる第3の切れ込みと、を備え、
     前記四角形は、4つの角のうち前記第1の切れ込みと対向する辺の両側の2つの角の少なくとも一方において2辺が交わらない形状、あるいは、前記第1の切れ込みと対向する辺に断続部を有する形状である被覆フィルム。
    A tamper-resistant coating film,
    A plurality of first cuts provided at intervals along the longitudinal direction;
    A second notch provided for each of the first notches and having a predetermined inclination angle with respect to the first notch;
    A third cut provided to form a quadrangle with the first cut and the two second cuts sandwiching the first cut,
    The quadrilateral has a shape in which two sides do not intersect at least one of two corners on both sides of the side facing the first cut out of the four corners, or an intermittent portion on the side facing the first cut. A coated film having a shape.
  2.  前記第3の切れ込みが前記第2の切れ込みと交差するように設けられる請求項1に記載の被覆フィルム。 The coating film according to claim 1, wherein the third cut is provided so as to intersect with the second cut.
  3.  前記第3の切れ込みが1つおきの前記第2の切れ込みと交差するように設けられる請求項2に記載の被覆フィルム。 The coating film according to claim 2, wherein the third cut is provided so as to intersect every other second cut.
  4.  前記第3の切れ込みが隣接する2つの前記第2の切れ込みの間に設けられる請求項1に記載の被覆フィルム。 The coating film according to claim 1, wherein the third cut is provided between two adjacent second cuts.
  5.  前記第3の切れ込みが前記第1の切れ込みと平行に設けられる請求項1~4のいずれかに記載の被覆フィルム。 The coating film according to any one of claims 1 to 4, wherein the third cut is provided in parallel with the first cut.
  6.  前記第2の切れ込みは、前記第1の切れ込みと交点を有するように設けられる請求項1~5のいずれかに記載の被覆フィルム。 The coating film according to any one of claims 1 to 5, wherein the second cut is provided so as to have an intersection with the first cut.
  7.  前記第2の切れ込みの前記第1の切れ込みに対する前記傾斜角度が30度~150度である請求項1~6のいずれかに記載の被覆フィルム。 The coating film according to any one of claims 1 to 6, wherein the inclination angle of the second cut with respect to the first cut is 30 to 150 degrees.
  8.  前記傾斜角度が45度である請求項7に記載の被覆フィルム。 The coating film according to claim 7, wherein the inclination angle is 45 degrees.
  9.  前記第1の切れ込み、前記第2の切れ込み及び前記第3の切れ込みは、切目が連続する線状又は切目が不連続に並ぶミシン目状のいずれかで形成されている請求項1~8のいずれかに記載の被覆フィルム。 The first notch, the second notch, and the third notch are formed in either a linear shape with continuous cuts or a perforated line with discontinuous cuts. A coated film according to any one of the above.
  10.  容器本体と、
     前記容器本体に着脱自在に取り付けられたキャップと、
     前記容器本体及び前記キャップの境目部分を覆うように外装される請求項1~9のいずれかに記載の被覆フィルムと、を備える包装容器。
    A container body;
    A cap detachably attached to the container body;
    A packaging container comprising: the covering film according to any one of claims 1 to 9, which is sheathed so as to cover a boundary portion between the container body and the cap.
  11.  シリンジ本体と、
     前記シリンジ本体に着脱自在に取り付けられたキャップと、
     前記シリンジ本体及び前記キャップの境目部分を覆うように外装される請求項1~9のいずれかに記載の被覆フィルムと、を備えるプレフィルドシリンジ。
     
     
    A syringe body;
    A cap detachably attached to the syringe body;
    10. A prefilled syringe comprising: the syringe main body and a covering film according to any one of claims 1 to 9, which is sheathed so as to cover a boundary portion of the cap.

PCT/JP2015/063430 2014-05-12 2015-05-11 Tamperproof covering film, packaging container and prefilled syringe WO2015174358A1 (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6379364U (en) * 1986-11-12 1988-05-25
JP2002311836A (en) * 2001-04-13 2002-10-25 Fujimori Kogyo Co Ltd Falsification prevention label and vessel with the label adhered thereon
US6746744B1 (en) * 1999-08-17 2004-06-08 Santen Pharmaceutical Co., Ltd. Sealing label
JP2010042817A (en) * 2008-08-08 2010-02-25 Kao Corp Virgin seal
JP2010233838A (en) * 2009-03-31 2010-10-21 Terumo Corp Medical instrument
JP2013130694A (en) * 2011-12-21 2013-07-04 Toppan Printing Co Ltd Label with tamper-proof function

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3603263B2 (en) * 1999-08-17 2004-12-22 参天製薬株式会社 Sealing label

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6379364U (en) * 1986-11-12 1988-05-25
US6746744B1 (en) * 1999-08-17 2004-06-08 Santen Pharmaceutical Co., Ltd. Sealing label
JP2002311836A (en) * 2001-04-13 2002-10-25 Fujimori Kogyo Co Ltd Falsification prevention label and vessel with the label adhered thereon
JP2010042817A (en) * 2008-08-08 2010-02-25 Kao Corp Virgin seal
JP2010233838A (en) * 2009-03-31 2010-10-21 Terumo Corp Medical instrument
JP2013130694A (en) * 2011-12-21 2013-07-04 Toppan Printing Co Ltd Label with tamper-proof function

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JPWO2015174358A1 (en) 2017-04-20

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