JP2006131291A - Vial lightproof packaging body and vial formulation with packaging body - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a lightproof packaging body provided with a superior lightproof characteristic for easily confirming the dissolution of a content in using and a vial formulation packaged in the lightproof packaging body. <P>SOLUTION: This vial formulation 1 comprises a vial main body 3 having a content 2 containing a chief remedy component, a vial cap 4 for covering the top opening of the main body 3 and a lightproof packaging body 5 covering the outside of the main body 3. The top end of the packaging body 5 is positioned at the neck 6 of the main body 3. The top end of the packaging body 5 may be positioned above the neck part 6, e.g., beside the cap 4 or at the upper end of the cap 4. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a light-shielding package having a structure that shields the entire surface of a vial preparation containing a light-unstable content and easily confirms the dissolution of the content during use, and a vial preparation provided with the light-shielding package .

As shown in FIG. 1, a vial preparation is a preparation containing a solid content (mainly powder) 51 containing a main drug in a vial 50, and includes a vial body 52 and a vial lid 53. A vial preparation is usually used by adjusting a solution in which contents are dissolved according to the following operation.
1. First, a needle of a syringe 55 filled with a solvent for injection (physiological saline or sterile water for injection) is inserted into the center of the vial lid 53, and the plunger 56 of the syringe is pushed in, whereby the solvent for injection 54 is removed from the vial body 52. Move inside.
2. After pulling out the needle of the syringe, the vial body 52 is gently shaken to dissolve the contents 51 in the solvent.
3. The syringe needle is again stabbed into the vial lid, and the syringe plunger 56 is pulled while the needle tip of the syringe is immersed in the solution, and the solution is sucked into the syringe 55.
4). The syringe needle is withdrawn from the vial and the lysate is administered to the patient via the syringe.

  When contents such as main ingredient components or additives to be placed in the vial are unstable with respect to light, it is necessary to shield the light from entering the vial. As a means for light shielding, there are a method of covering the barrel portion with a light-shielding film, a method of using a vial colored brown, a method of combining these, and the like.

When the barrel part of the vial is covered with a light-shielding film, the part from the shoulder to the neck of the vial is exposed, and light enters from the exposed part, so the content is very poor in light stability. In the case of objects, it cannot be said that the light-shielding effect is sufficient, and decomposition of the contents due to the intruding light has occurred.
When using colored vials, the light-shielding effect is not sufficient compared to the light-shielding film, and the inside is difficult to see from the outside of the vial. There is a problem that it is difficult to accurately absorb the entire amount of the injection solution when the injection solution is sucked.
In addition, when the barrel of a colored vial is covered with a light-shielding film, a vial that is inferior from the viewpoint of the light stability of the contents is obtained due to the coloring of the vial itself and the light-shielding effect of the light-shielding film. However, it was difficult to observe the inside of the vial because of the coloring of the vial itself and the light-shielding film.

  In order to solve this problem, the inventors of the present application have completed the present invention as a result of intensive studies. An object of the present invention is to provide a light-shielding package that is excellent in light-shielding properties and that allows easy confirmation of dissolution of contents during use, and a vial preparation that is provided with the light-shielding package. The problems of the conventional vial preparation described above are solved by a light-shielding package having an observation opening on the bottom of the vial preparation and a daylighting portion formed by removing the upper part of the light-shielding package during adjustment.

  According to the light-shielding package of the present invention, the vial preparation provided with the light-shielding package is shielded from the entire vial by the light-shielding package during storage, so that the contents are not decomposed by external light. . Also, when adjusting the injection solution, there is a daylighting part at the top of the ampoule preparation and an observation opening at the bottom, so that the contents are dissolved and sucked by the syringe while putting some light from the outside. Can be observed. Therefore, the light-shielding package of the present invention is a light-shielding package having both light-shielding properties during storage and good operability during adjustment.

  The best mode for carrying out the present invention will be described below.

  The vial preparation 1 of the present invention has, for example, the structure shown in FIG. 2, and includes a vial body 3 containing a content 2 containing a main ingredient, a vial lid 4 and a vial body for closing the upper opening of the vial body 3. 3 and a light-shielding package 5 that covers the outside of 3. FIG. 2 shows an example in which the upper end of the light shielding package 5 is located at the neck 6 of the vial body, but the upper end of the light shielding package 5 is located above the neck 6 as shown in FIG. It may be in the position of the side of the vial lid 4 or the upper end of the vial lid 4.

The contents that can be used in the present invention are compounds that are unstable to light (compounds that undergo a reaction such as decomposition, rearrangement, polymerization, or isomerization when exposed to light, resulting in a structure different from the initial compound) ), And is not particularly limited as long as it is a compound that is unstable to light. For example, vitamin B ₁₂ such as mecobalamin (methylcobalamin), vitamin E, vitamin B ₂ , menatetrenone, etc. Can be mentioned.

  The vial preparation of the present invention is a preparation used after the contents are dissolved, and examples thereof include a powder preparation such as a freeze-dried preparation for injection. Moreover, a vial can be used without particular limitation as long as it has a capacity of about 1.5 ml to 100 ml, for example, regardless of its size. As a material of the vial, a glass material is often used, but is not limited thereto, and other materials such as a transparent resin may be used. The vial body 3 shown in FIG. 3 has a side wall formed in a cylindrical shape from the bottom of a circular vial. A shoulder portion 8 is formed at the upper portion of the side wall so that the diameter gradually decreases. A neck portion 6 is formed by raising substantially vertically at the upper end of the shoulder portion 8, and the upper end of the neck portion 6 is open to form an opening. An opening (not shown) including the contents 2 is closed by the vial lid 4. A packing (not shown) is provided inside the vial lid 4, and the packing is in close contact with the inner wall of the opening so that the inside of the vial body 3 is sealed.

  FIG. 3 is a view showing a state before use (during storage) of the vial preparation of the present invention, and the light-shielding package 5 covers the substantially entire surface of the vial body 3 to protect the contents. As shown in FIG. 3B, an observation opening 9 for observing the inside from the outside is formed at the center of the package bottom surface 7. The shape of the observation opening 9 is not particularly limited as long as it is possible to confirm the dissolution of the contents from the outside, and may be an ellipse, a rectangle, a hexagon, etc. in addition to a circle. Also good. The size of the observation opening 9 is not particularly limited as long as the dissolution of the contents 2 can be confirmed from the outside. When the observation opening is circular, the observation opening 9 has a diameter of about 5 mm or more. It is enough. The observation opening 9 may be formed by providing a part of the package bottom surface 7 where the light-shielding package 5 is not present, or only a part of the package bottom surface 7 is made transparent. This may be the observation opening 9. Moreover, the observation opening part 9 should just exist at the time of adjustment of an injection solution, and does not necessarily need to exist at the time of normal preservation | save. For example, the observation opening 9 may be formed by peeling off or cutting out a part of the bottom surface 7 of the package when adjusting the injection solution. However, normally, since the bottom surface of the vial faces the floor, light does not enter there so much that the contents are not decomposed, so the entire package bottom surface 7 can be used as the observation opening 9.

  The light-shielding package 5 includes a light-shielding main body portion 18 that covers at least the shoulder portion 8 from the bottom surface of the vial body 3 and a light-shielding upper portion 17 that is above the light-shielding main body portion 18. At the time of use (when adjusting the injection solution), the daylighting part 11 is formed by removing the light-shielding upper part 17 and used. Examples of the method for forming the daylighting unit 11 include a method of peeling or cutting off the light-shielding upper portion 17 and is not particularly limited. As an example, a configuration in which the light shielding upper portion 17 is cut out will be described with reference to FIG. In this embodiment, as shown in FIG. 4A, the light shielding package 5 has a horizontal cutout line 12 so as to make one round of the vial body 3 in the horizontal direction at a portion above the shoulder portion 8 of the vial. Is formed. Further, two vertical cut lines 13 are formed from the horizontal cut line 12 to the upper end of the light shielding package 5, and a vertical cut portion 14 is formed between the two vertical cut lines 13. . A knob portion 15 is formed at the upper end of the vertical cut portion 14. The knob 15 shown in FIG. 4A has a shape that protrudes upward from the light-shielding package 5, but as long as it is a shape that can be picked with a finger to cut out the vertical cut portion 14, the light-shielding package 5. It is not necessary to project upward from the shape, and the shape is not particularly limited. As a procedure for cutting off the light-shielding upper portion 17, first, the knob portion 15 is picked and pulled downward to cut the longitudinal cut portion 14 (FIGS. 4A to 4B). Next, the lighting part 11 is formed above the light-shielding main body part 18 by cutting out the upper part of the light-shielding package 5 along the horizontal cut-out line 12 (FIGS. 4B to 4C). If the horizontal cut-out line 12 is positioned below the shoulder 8, the light-shielding package 5 is easily removed from the vial body 3, and since the daylighting portion 11 is enlarged, the light-shielding effect is also reduced. The line 12 is preferably above the shoulder 8. Although FIG. 4 shows a light-shielding package having two vertical cut lines, there may be only one vertical cut line or three or more vertical cut lines.

  As a material of the light-shielding package 5 that can be used in the present invention, for example, a resin film, paper, metal foil, coating, and the like and a combination thereof can be used. It is good to use. Specific examples of the resin film include shrink wrapping packaging materials such as PET (polyethylene terephthalate), polyethylene, polypropylene, polystyrene, and vinyl chloride. Among these, a preferable resin film is PET. In the case of using a resin film, a resin obtained by kneading a light shielding component, a resin obtained by printing a light shielding component such as a pigment on a synthetic resin (solid printing), or a laminate of these resin films is used. Good. The light shielding package 5 does not need to be formed as a whole, and may be composed of two or more parts. In this case, different materials may be used for the respective parts. For example, the light-shielding main body 18 is made of a resin film, the light-shielding upper portion 17 is made of a light-shielding paper seal, and the light-shielding paper seal is peeled off and the daylighting portion 11 appears when used. There may be.

(Adjustment of injection solution)
When adjusting the injection solution, the daylighting unit 11 (and the observation opening 9 in some cases) is formed, and then the syringe needle filled with an injection solvent such as physiological saline or sterile water for injection is placed on the vial lid. The injection solvent is injected into the inside of the vial. After removing the syringe needle from the vial lid, the contents are dissolved in the solvent for injection. While shaking the vial as necessary, light is introduced from the daylighting unit 11 and the inside of the vial is observed from the observation opening 9 (FIG. 5A), or light is emitted from the observation opening 9 by turning the vial in the reverse direction. Then, the inside of the vial is observed from the daylighting unit 11 (the same (B)), and dissolution of the contents is confirmed. After confirming that the contents are completely dissolved, the prepared solution (injection solution) is sucked out using the above-described syringe. When sucking the injection solution 20, as shown in FIG. 6, the ampule lid is inserted with the syringe upside down, and the cut 22 formed in the packing 21 of the ampule lid 4 from the side of the daylighting unit 11 is formed. By sucking while looking in, it is possible to prevent the unsucked injection solution 20 from being left behind.

EXAMPLES Next, although an Example demonstrates this invention further in detail, this invention is not limited to this Example.
(Example)
A shrink 30 formed into a flower pot shape having an opening larger than the bottom as shown in FIG. 7 was manufactured using a heat-shrinkable PET light-shielding film (thickness: 60 μm, four-color solid printing). The bottom surface of the shrink is slightly larger than the bottom surface of the vial body, and an observation opening 9 is formed on the bottom surface of the shrink. Although not shown, the shrink 30 is previously formed with a vertical cut line, a horizontal cut line, and a knob.
1. From the shrink opening, fit a vial sealed with the contents (mecobalamin lyophilizer).
2. By applying heat to the bottom surface of the shrink for a few seconds with the vial formulation fitted, the shrinkage is contracted and brought into close contact with the bottom surface of the vial formulation.
3. Next, 2. The vial preparation obtained in (1) is introduced into a tunnel shrink (temperature in the tunnel of 160 ° C.) while being rotated on a rotating belt conveyor in a lying state, and the whole is heated.
4). The heat applied in the tunnel shrink causes the shrink to shrink and adhere to the vial formulation.
By the above operation, a vial preparation was obtained which was entirely covered with a PET light-shielding film.

It is explanatory drawing showing the use condition of a normal ampoule. It is explanatory drawing showing the ampoule formulation of this invention. It is the perspective view of the ampoule formulation of this invention, (A) is the perspective view seen from upper direction, (B) is the perspective view seen from the downward direction. It is explanatory drawing showing how to take out the lighting part of the light-shielding package of this invention. It is explanatory drawing showing the state which adjusts the injection solution of the ampoule formulation of this invention. It is a side view which shows the state which absorbs the injection solution of the ampoule formulation of this invention with a syringe. It is explanatory drawing which shows the manufacture process of the light-shielding package of this invention.

Explanation of symbols

5 Light-shielding package 9 Observation opening 11 Daylighting part 12 Horizontal cut line 13 Vertical cut line 14 Vertical cut part 15 Knob part 17 Light-shielding upper part 18 Light-shielding body part

Claims (7)

A side wall formed in a cylindrical shape at the periphery of the bottom surface, a shoulder formed at the top of the side wall, a neck formed by standing substantially vertically above the shoulder, and a vial disposed on the top of the neck A vial light-shielding package comprising a lid,
A light-shielding main body extending from the bottom of the vial to at least the shoulder so as to shield the ingress of light from the outside, and an observation opening through which the inside of the vial can be observed from the bottom of the vial. A light-shielding main body having a portion;
The upper part of the light-shielding main body part covers the vial lid and the neck part, and the upper part of the light-shielding main body part is connected to the upper part of the light-shielding main body part via a horizontal cutting line,
And a light shielding package.   The light-shielding package according to claim 1, further comprising a vertical cut-out line that is substantially orthogonal to the horizontal cut-out line and extends from the upper side to the upper end of the light-shielding package from the horizontal cut-out line.   The light-shielding package according to claim 2, wherein the light-shielding packaging body has at least two vertical cut lines, and a standing cut portion is formed between any two vertical cut lines.   The light-shielding package according to claim 3, further comprising a knob at an upper end of the vertical cut portion. A side wall formed in a cylindrical shape at the periphery of the bottom surface, a shoulder formed at the top of the side wall, a neck formed by standing substantially vertically above the shoulder, and a vial disposed on the top of the neck A vial light-shielding package comprising a lid,
A light-shielding main body extending from the bottom of the vial to at least the shoulder so as to shield light from entering from the outside, wherein a part of the bottom of the main body is attached to the vial from the bottom of the vial. A light-shielding main body having an observation opening through which the inside can be observed;
Covering the vial lid, the neck, touching or overlapping the light-shielding main body, and a light-shielding upper part removable from the light-shielding main body;
A light-shielding package comprising:   The light-shielding package according to claim 5, wherein the light-shielding main body part and the light-shielding upper part are connected via a cut line. A drug inside the vial;
The light-shielding package according to any one of claims 1 to 6, which packages the vial;
Vial formulation with

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