CN209971778U - Packaging composite film for oral liquid medicine - Google Patents
Packaging composite film for oral liquid medicine Download PDFInfo
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- CN209971778U CN209971778U CN201920459783.8U CN201920459783U CN209971778U CN 209971778 U CN209971778 U CN 209971778U CN 201920459783 U CN201920459783 U CN 201920459783U CN 209971778 U CN209971778 U CN 209971778U
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Abstract
The utility model provides a packaging composite film for oral liquid medicine, which comprises a printing layer, a first adhesive layer, a first barrier layer, a second adhesive layer, a second barrier layer, a third adhesive layer and a heat sealing layer which are sequentially bonded with each other from outside to inside; the second barrier layer is a biaxially oriented polyethylene terephthalate film layer. The utility model provides a medicinal complex film has excellent separation nature and material lightweight, and the cost is moderate, and medicine active ingredient can obtain preserving for a long time, and the transportation is convenient, resistant extrusion collision.
Description
Technical Field
The utility model belongs to the technical field of packaging material, a oral liquid medicine is with packing complex film is related to.
Background
The liquid medicine package in the traditional market mainly adopts hard packages such as glass products, plastic sheets and the like, and the packaging material has the advantages of heavy weight, high cost and difficulty in transportation and circulation. Since 9/8/2015, the State administration issued (2015) 44 on the opinion on the evaluation and approval system of the reformed drug and medical devices and 10/2016, the State food and drug administration and administration issued supplementary bulletin (2016 No. 134) on the related items of the drug package material and drug related evaluation and approval by the State administration of food and drug supervision and administration, which is stated explicitly in the bulletin, the pharmaceutical enterprises autonomously declare the related evaluation of the package material and encourages the development of novel drug packages.
The effective components of oral liquid medicine generally contain components which are easy to react and lose efficacy, such as menthol, green almond and the like, and the substances have higher permeability. Meanwhile, the aromatic adhesive frequently used in the prior art is easy to react with the active ingredients of the medicines, and the storage stability of the medicines is influenced.
CN106240001A provides a high resistant pharmaceutical complex film that separates, from last to having set gradually protective layer, first gluing agent layer, first aluminium foil layer, second gluing agent layer, second aluminium foil layer, third gluing agent layer and heat-seal layer down, this patent adopts double-deck aluminium foil composite construction, has improved the separation nature of aluminium foil complex film, but it has all adopted the aluminium foil, leads to its separation performance not high enough, and too much weight and the cost problem of considering the complex film. CN106218137A discloses a medicinal aluminum foil composite film, which comprises: the printing layer, the outer film layer, the first bonding glue layer, the aluminum foil layer, the second bonding glue layer and the heat sealing layer are arranged from outside to inside in sequence, and the first bonding glue layer and the second bonding glue layer respectively comprise the following components in parts by weight: 5-8 parts of sodium hydroxide, 1-3 parts of calcium formate, 1-3 parts of acetic acid-cellulose nitrate, 1-3 parts of magnesium oxide, 2-4 parts of a lubricant, 30-40 parts of chlorohydrin rubber, 10-15 parts of tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer, 5-10 parts of carboxymethyl starch, 15-25 parts of low-density polyethylene, 5-10 parts of coconut monoethanolamide, 10-15 parts of resinous neoprene, 5-12 parts of polyoctanamide and 15-20 parts of water; the main concern is the anti-aging properties of the adhesive, not much related to the permeability of the material and the long-term storage stability of the pharmaceutical product.
There is a need to develop a composite film for oral liquid medicines, which has high barrier properties and can ensure long-term storage of effective ingredients of medicines.
SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide an oral liquid medicine is with packing complex film. The utility model provides a medicinal complex film has excellent separation nature and material lightweight, and the cost is moderate, and medicine active ingredient can obtain preserving for a long time, and the transportation is convenient, resistant extrusion collision.
In order to achieve the purpose of the utility model, the utility model adopts the following technical proposal:
the utility model provides an oral liquid medicine is with packing complex film, the packing complex film includes printing layer, first adhesive layer, first barrier layer, second adhesive layer, second barrier layer, third adhesive layer and the heat-seal layer that bonds each other in proper order from outside to inside.
The second barrier layer is a biaxially oriented polyethylene terephthalate film layer.
The utility model discloses set up two-layer barrier layer, wherein the second barrier layer is biaxial stretching polyethylene terephthalate film layer, and it has higher separation performance and high deflection, cooperates the use of first barrier layer, makes the utility model provides a when the whole separation nature of packaging composite membrane is close glass material or plastic sheet, greatly reduced the weight of packing, make the packing lightweight.
In the present invention, the printing layer (1) is a biaxially oriented polypropylene film layer (BOPP), a biaxially oriented polyethylene terephthalate film layer (PET) or a biaxially oriented polyamide film layer (PA) and has a thickness of 10 to 30 μm, for example, 11 μm, 12 μm, 15 μm, 18 μm, 20 μm, 22 μm, 25 μm, 28 μm, etc., but is not limited to the values listed, and other values not listed in the numerical range are also applicable.
In the utility model discloses, printing layer is biaxial stretching polyethylene terephthalate film layer, and thickness is 12 mu m.
The biaxially oriented polyethylene terephthalate film has excellent printing adaptability, stretch resistance and other processing properties, and a printing layer with required pictures and texts can be obtained in an inner printing mode.
In the present invention, the first pressure-sensitive adhesive layer is an aromatic urethane pressure-sensitive adhesive layer having a thickness of 1.0 to 5.0 μm, for example, 1.2 μm, 1.5 μm, 2.0 μm, 2.5 μm, 3.0 μm, 3.5 μm, 4.0 μm, 4.5 μm, 4.8 μm, etc., but is not limited to the values listed, and other values not listed in the numerical range are also applicable.
In the present invention, the first barrier layer is an aluminum foil layer having a thickness of 7 to 25 μm, for example, 8 μm, 9 μm, 12 μm, 15 μm, 20 μm, 22 μm, etc., but is not limited to the values listed, and other values not listed in the range of the values are also applicable.
The utility model discloses a composite barrier layer including first barrier layer and second barrier layer, first barrier layer mainly is the high separation nature that utilizes the aluminium foil, but the aluminium foil membrane is because of the production technology restriction, and its surface inevitable existence pinhole influences the separation effect, so set up the second barrier layer, utilize the higher separation nature and the high deflection of biaxial stretching polyethylene terephthalate film, make the utility model discloses a whole separation nature of complex film has and increases substantially, is close to the separation nature of glass material and plastic sheeting.
In the present invention, the thickness of the first barrier layer is 7 μm.
In the present invention, the second adhesive layer and the third adhesive layer are both aliphatic polyurethane adhesive layers, and the thickness is independently selected from 1.0-5.0 μm, such as 1.2 μm, 1.5 μm, 2.0 μm, 2.5 μm, 3.0 μm, 3.5 μm, 4.0 μm, 4.5 μm, 4.8 μm, etc., but not limited to the values listed, and other values not listed in the range of the values are also applicable.
The raw material of the aliphatic polyurethane adhesive layer is preferably a two-component polyurethane adhesive (aliphatic).
In order to reduce the reaction between the aromatic polyurethane adhesive and the active ingredient in the oral liquid medicine, the second adhesive layer and the third adhesive layer of the present invention both use the aliphatic polyurethane adhesive, which can reduce the reaction rate with the active ingredient in the oral liquid medicine, but the cost is relatively higher than that of the generally used aromatic polyurethane adhesive, and the inner layer has been provided with two barrier layers, so the first adhesive layer can use the aromatic polyurethane adhesive layer in consideration of the cost.
In the present invention, the thickness of the second barrier layer is 10 to 30 μm, for example, 12 μm, 15 μm, 17 μm, 20 μm, 22 μm, 23 μm, 25 μm, 28 μm, etc., but it is not limited to the values listed, and other values not listed in the range of the values are also applicable.
In the present invention, the thickness of the second barrier layer is 12 μm.
In the present invention, the heat-sealing layer is a multilayer coextruded polyolefin film layer having a thickness of 25 to 120 μm, for example, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, etc., but is not limited to the values listed, and other values not listed in this range are also applicable.
The preparation method of the packaging composite membrane for the oral liquid medicine provided by the utility model can comprise the following steps:
(1) adopting a three-layer co-extrusion blow molding process, heating and melting low-density polyethylene, linear low-density polyethylene and metallocene linear low-density polyethylene by three screws, and co-extruding and blow molding to obtain a three-layer co-extrusion blow molding polyethylene film as a heat sealing layer;
(2) printing required image-text information on the corona surface of the biaxially oriented polyester film by adopting a gravure printing process to obtain the biaxially oriented polyester film with an inner print;
(3) and laminating and compounding the biaxially oriented polyester film with the inner print, the aluminum foil, the non-printed biaxially oriented polyester film and the three-layer co-extrusion blow molding polyethylene film in sequence by using a double-component polyurethane adhesive by adopting a dry compounding process, wherein the printing surface of the printed biaxially oriented polyethylene terephthalate film, the aluminum foil, the compound surface of the heat sealing layer and the non-printed biaxially oriented polyethylene terephthalate film are laminated and compounded together, and the packaging composite film for the oral liquid medicine is obtained.
Compared with the prior art, the utility model discloses following beneficial effect has:
(1) the second barrier layer is made of a biaxially oriented polyethylene terephthalate film which has high barrier property and high stiffness, and is matched with the first barrier layer for use, so that the finally obtained composite film has excellent barrier property, the packaging material is light in weight, and the cost is moderate;
(2) the second adhesive layer and the third adhesive layer both adopt aliphatic polyurethane adhesive, which effectively reduces the reaction rate with effective components in the oral liquid medicine and ensures that the medicine effect is preserved for a long time;
(3) the utility model provides a complex film transportation is convenient, and resistant extrusion collision can also arrange the use in a flexible way according to user's needs, prefabricates various types of wrapping bags, perhaps directly provides the roll membrane and independently packs by the user.
Drawings
Fig. 1 is a schematic structural diagram of a packaging composite film for oral liquid medicine provided by the present invention.
Wherein, 1-printing layer; 2-a first adhesive layer; 3-a first barrier layer; 4-a second adhesive layer; 5-a second barrier layer; 6-a third adhesive layer; 7-heat sealing layer.
Detailed Description
The technical solution of the present invention will be further explained by the following embodiments. It should be understood by those skilled in the art that the described embodiments are merely provided to assist in understanding the present invention and should not be construed as specifically limiting the present invention.
Example 1
The embodiment provides a packaging composite film for oral liquid medicines, which comprises a printing layer 1, a first adhesive layer 2, a first barrier layer 3, a second adhesive layer 4, a second barrier layer 5, a third adhesive layer 6 and a heat sealing layer 7 which are sequentially bonded with one another from outside to inside as shown in fig. 1.
Wherein, the printing layer 1 is bonded with the first barrier layer 3 through the first binder layer 2, the first barrier layer 3 is bonded with the second barrier layer 5 through the second binder layer 4, and the second barrier layer 5 is bonded with the heat seal layer 7 through the third binder layer 6.
Wherein, the printing layer 1 is a biaxial stretching polyethylene terephthalate film layer with the thickness of 12 μm.
The first adhesive layer 2 was an aromatic urethane adhesive layer and had a thickness of 2.0 μm.
The first barrier layer 3 is an aluminum foil layer with a thickness of 7 μm.
The second adhesive layer 4 was an aliphatic polyurethane adhesive layer and had a thickness of 2.0 μm.
The second barrier layer 5 is a biaxially oriented polyethylene terephthalate film layer having a thickness of 12 μm.
The third adhesive layer 6 was an aliphatic polyurethane adhesive layer and had a thickness of 2.0 μm.
The heat sealing layer 7 is a three-layer polyethylene film layer (coextruded by low density polyethylene, linear low density polyethylene and metallocene linear low density polyethylene) with the thickness of 70 μm.
Example 2
The difference from example 1 is that the printed layer 1 of this example is a biaxially oriented polyamide film layer having a thickness of 15 μm.
Example 3
The difference from embodiment 1 is that the printing layer 1 of this embodiment is a biaxially oriented polypropylene film layer with a thickness of 20 μm.
Example 4
The embodiment provides a packaging composite film for oral liquid medicines, which comprises a printing layer 1, a first adhesive layer 2, a first barrier layer 3, a second adhesive layer 4, a second barrier layer 5, a third adhesive layer 6 and a heat sealing layer 7 which are sequentially bonded with one another from outside to inside.
Wherein, the printing layer 1 is bonded with the first barrier layer 3 through the first binder layer 2, the first barrier layer 3 is bonded with the second barrier layer 5 through the second binder layer 4, and the second barrier layer 5 is bonded with the heat seal layer 7 through the third binder layer 6.
Wherein, the printing layer 1 is a biaxially oriented polyethylene terephthalate film layer with a thickness of 10 μm.
The first adhesive layer 2 was an aromatic urethane adhesive layer and had a thickness of 1.0 μm.
The first barrier layer 3 is an aluminum foil layer with a thickness of 15 μm.
The second adhesive layer 4 was an aliphatic polyurethane adhesive layer and had a thickness of 5.0 μm.
The second barrier layer 5 is a biaxially oriented polyethylene terephthalate film layer having a thickness of 20 μm.
The third adhesive layer 6 was an aliphatic polyurethane adhesive layer and had a thickness of 1.0 μm.
The heat sealing layer 7 is a three-layer polyethylene film layer (coextruded by low density polyethylene, linear low density polyethylene and metallocene linear low density polyethylene) with a thickness of 25 μm.
Example 5
The embodiment provides a packaging composite film for oral liquid medicines, which comprises a printing layer 1, a first adhesive layer 2, a first barrier layer 3, a second adhesive layer 4, a second barrier layer 5, a third adhesive layer 6 and a heat sealing layer 7 which are sequentially bonded with one another from outside to inside.
Wherein, the printing layer 1 is bonded with the first barrier layer 3 through the first binder layer 2, the first barrier layer 3 is bonded with the second barrier layer 5 through the second binder layer 4, and the second barrier layer 5 is bonded with the heat seal layer 7 through the third binder layer 6.
Wherein, the printing layer 1 is a biaxial stretching polyethylene terephthalate film layer with the thickness of 30 μm.
The first adhesive layer 2 was an aromatic urethane adhesive layer and had a thickness of 5.0 μm.
The first barrier layer 3 is an aluminum foil layer with a thickness of 25 μm.
The second adhesive layer 4 was an aliphatic polyurethane adhesive layer and had a thickness of 4.0 μm.
The second barrier layer 5 is a biaxially oriented polyethylene terephthalate film layer having a thickness of 30 μm.
The third adhesive layer 6 was an aliphatic polyurethane adhesive layer and had a thickness of 5.0 μm.
The heat sealing layer 7 is a three-layer polyethylene film layer (coextruded by low density polyethylene, linear low density polyethylene and metallocene linear low density polyethylene) with the thickness of 120 μm.
Comparative example 1
This comparative example is a commercially available PET bottle for pharmaceutical use.
Comparative example 2
The comparative example is a commercially available pharmaceutical suppository.
Comparative example 3
The difference from example 1 is that in this comparative example, the second adhesive layer 4 and the third adhesive layer 6 are both aromatic polyurethane adhesive layers.
Performance testing
The packaging composite films for oral liquid provided in examples 1 to 5 and comparative examples 1 to 3 were subjected to a performance test by the following method:
(1) barrier properties: testing the water vapor transmission rate of the composite film by using a GB/T26253 method for measuring the water vapor transmission rate of the plastic film and the thin sheet by an infrared detector method;
testing the oxygen transmission rate of the packaging composite film by adopting a GB/T19789 packaging material plastic film and thin sheet oxygen transmission test;
the test results for the composite films for packaging oral liquids provided in examples 1 to 5 and comparative examples 1 to 3 are shown in table 1.
TABLE 1
For the apparatus that tested the water vapor transmission rate, the maximum accuracy value of the apparatus was 0.01, whereas the water vapor transmission rate of example 5 was already less than this accuracy value.
As can be seen from the examples and performance tests, the utility model provides a packaging composite film for oral liquid has good barrier properties, wherein, the vapor permeation of packaging composite filmThe rate is less than 1g/m224h (38 ℃, 90% RH) and an oxygen transmission rate of less than 1cm3/m2·24h·0.1MPa(23℃)。
As can be seen from the comparison between the examples and the comparative examples, the barrier property of the packaging composite film provided by the utility model is obviously superior to that of the existing PET bottles and suppositories sold in the market.
(2) Testing compatibility of the packaging material with medicines: and (3) carrying out an accelerated aging test, testing the compatibility of the composite film and the contents under the conditions of the temperature of 25 +/-2 ℃ and the relative humidity of 60 +/-10% according to the instruction principle of a drug packaging material and drug compatibility test of YBB00142002-2015, and carrying out statistics on the corresponding proportion of the effective components (menthol) of the contents before and after the test (the content of the effective components of the contents is more than or equal to 90% after 6 months of standard requirement).
The test results are shown in table 2:
TABLE 2
| Sample (I) | One month | Two months old | Three months old | Four months old | Five months old | Six months old |
| Example 1 | 98％ | 98％ | 97％ | 96％ | 94％ | 93％ |
| Example 2 | 99％ | 98％ | 97％ | 97％ | 96％ | 95％ |
| Example 3 | 98％ | 97％ | 96％ | 96％ | 95％ | 95％ |
| Example 4 | 98％ | 96％ | 96％ | 95％ | 94％ | 93％ |
| Example 5 | 99％ | 98％ | 98％ | 97％ | 97％ | 96％ |
| Comparative example 1 | 98％ | 97％ | 95％ | 95％ | 93％ | 93％ |
| Comparative example 2 | 98％ | 95％ | 94％ | 93％ | 93％ | 91％ |
| Comparative example 3 | 85％ | 78％ | 63％ | 57％ | 51％ | 46％ |
According to the embodiment and the performance test, the utility model provides an oral liquid is with packing complex film can make the drug effect preserve for a long time, and when 6 months through the accelerated aging test, the active ingredient (menthol) proportion in the liquid medicament still is more than 90%.
As can be seen from the comparison of embodiment and comparative example 1-2, the utility model provides a composite packaging film for oral liquid can compare favourably (even be superior to) the preservation of active ingredient in the medicine to present PET bottle, suppository, can know from the comparison of embodiment 1 and comparative example 3, the utility model discloses a second adhesive layer and third adhesive layer all adopt aliphatic polyurethane binder, can effectively reduce with the reaction rate of active ingredient (menthol) in the oral liquid medicine, make the effect of medicine preserve for a long time.
The utility model provides a unit area (1 m) of a packaging composite film for oral liquid medicine2) The weight is 40-60% of the conventional sheet plastic medicinal package, and the cost is 70-90% of the sheet plastic medicinal package, so that the application requirement of the product can be met.
The applicant states that the present invention is illustrated by the above embodiments, but the present invention is not limited to the above process steps, i.e. the present invention is not meant to rely on the above process steps to implement the present invention. It should be clear to those skilled in the art that any improvement of the present invention is to the equivalent replacement of the selected raw materials, the addition of auxiliary components, the selection of specific modes, etc., all fall within the protection scope and disclosure scope of the present invention.
Claims (10)
1. The packaging composite film for the oral liquid medicine is characterized by comprising a printing layer (1), a first adhesive layer (2), a first barrier layer (3), a second adhesive layer (4), a second barrier layer (5), a third adhesive layer (6) and a heat sealing layer (7) which are sequentially bonded with one another from outside to inside;
the second barrier layer (5) is a biaxially oriented polyethylene terephthalate film layer.
2. The packaging composite film for oral liquid medicines according to claim 1, wherein the print layer (1) is a biaxially oriented polypropylene film layer, a biaxially oriented polyethylene terephthalate film layer or a biaxially oriented polyamide film layer, and has a thickness of 10 to 30 μm.
3. The packaging composite film for oral liquid medicine according to claim 2, wherein the printing layer (1) is a biaxially oriented polyethylene terephthalate film layer having a thickness of 12 μm.
4. The packaging composite film for oral liquid medicine according to claim 1, wherein the first adhesive layer (2) is an aromatic polyurethane adhesive layer having a thickness of 1.0-5.0 μm.
5. The packaging composite film for oral liquid medicine according to claim 1, wherein the first barrier layer (3) is an aluminum foil layer having a thickness of 7-25 μm.
6. Packaging composite film for oral liquid pharmaceutical product according to claim 5, characterized in that the thickness of the first barrier layer (3) is 7 μm.
7. The oral liquid pharmaceutical packaging composite film according to claim 1, wherein the second adhesive layer (4) and the third adhesive layer (6) are both aliphatic polyurethane adhesive layers, each independently selected from 1.0-5.0 μm in thickness.
8. Packaging composite film for oral liquid pharmaceutical products according to claim 1, characterised in that the thickness of the second barrier layer (5) is 10-30 μm.
9. Packaging composite film for oral liquid pharmaceutical products according to claim 8, characterised in that the thickness of the second barrier layer (5) is 12 μm.
10. The packaging composite film for oral liquid pharmaceuticals according to claim 1, wherein the heat-sealing layer (7) is a multilayer coextruded polyolefin film layer having a thickness of 25 to 120 μm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201920459783.8U CN209971778U (en) | 2019-04-04 | 2019-04-04 | Packaging composite film for oral liquid medicine |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201920459783.8U CN209971778U (en) | 2019-04-04 | 2019-04-04 | Packaging composite film for oral liquid medicine |
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| CN209971778U true CN209971778U (en) | 2020-01-21 |
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