Non-PVC co-extrusion infusion film with three-layer structure

Abstract

The invention provides a non-PVC (polyvinyl chloride) co-extrusion infusion film with a three-layer structure. The co-extrusion film is prepared from an inner layer, a middle layer and an outer layer by adopting a co-extrusion process without using an adhesive. Wherein the inner layer is mainly composed of PP and POP, and the thickness of the inner layer is 30-50 [mu] m; the middle layer is mainly composed of PE and POP, and the thickness of the middle layer is 110-150 microns; the outer layer is mainly composed of PP and POP, and the thickness of the outer layer is 20-50 microns. The prepared membrane material is suitable for packaging of various kinds of transfusion. The light transmittance, heat sealing strength, 121 DEG C cooking resistance and the like of the film are guaranteed, and the film material has excellent low-temperature resistance while having excellent performance of a traditional three-layer co-extrusion infusion film.

Description

Technical Field

[0001] The present invention relates to a film for packaging intravenous infusion drugs, and specifically to a co-extruded infusion film with a three-layer structure. Background Art

[0002] The non-PVC multi-layer co-extruded infusion film is a new type of infusion packaging material that has developed rapidly in recent years. It is an environmentally friendly packaging material with a light texture, good transparency, non-toxic, and odorless. The non-PVC multi-layer co-extruded infusion film mainly includes a three-layer co-extruded infusion film and a five-layer co-extruded infusion film.

[0003] The non-PVC multi-layer co-extruded infusion film is a commonly used infusion product packaging material in today's European and American countries. Compared with the commonly used glass and PVC materials in the Chinese market, it is more in line with the national industrial policy and is the direction of the drug packaging materials encouraged by the state. The non-PVC multi-layer co-extruded infusion film has the following characteristics: 1. The composition of the non-PVC multi-layer co-extruded infusion film does not contain plasticizers, and there is no risk of DEHP leakage; 2. The non-PVC multi-layer co-extruded infusion film has good thermal stability, can be sterilized by high-temperature steam at 121 °C, and the transparency of the product changes little under the condition of high-temperature sterilization, and the transparency is good; 3. The non-PVC multi-layer co-extruded infusion film has a very low water vapor transmission rate, keeps the infusion concentration stable, and can ensure the product storage period; 4. The non-PVC multi-layer co-extruded infusion film has strong flexibility and can self-shrink. Under the action of atmospheric pressure, the liquid medicine can be infused through the closed infusion pipeline, eliminating the risk of air pollution and embolism caused by air bubbles. At the same time, it is beneficial for first aid and urgent use in ambulances; 5. The non-PVC multi-layer co-extruded infusion film material is relatively easy to process. After incineration, it only produces water, carbon dioxide, etc., does not produce irritating odors and other harmful substances, and is harmless to the environment.

[0004] Among them, the three-layer co-extruded infusion film has slightly worse flexibility than the five-layer co-extruded infusion film, a harder texture, and relatively poor low-temperature resistance, but has lower requirements for equipment.

[0005] Therefore, the present invention proposes a three-layer co-extruded infusion film that combines the advantages of both the five-layer co-extruded infusion film and the three-layer co-extruded infusion film, that is, the three-layer co-extruded infusion film has lower requirements for equipment and the five-layer co-extruded infusion film has more excellent low-temperature resistance, meeting the performance requirements of intravenous infusion packaging materials. Summary of the Invention

[0006] The present invention aims at the above problems and provides a non-PVC co-extruded infusion film with a three-layer structure. This film has the advantages of non-toxicity, good printability, resistance to cooking, high light transmittance, high heat-sealing strength, good flexibility, etc.

[0007] The co-extruded infusion film with a three-layer structure of the present invention is a three-layer composite film, and its composition from the inner layer to the outer layer is: polypropylene + polyolefin plastomer, polyethylene + polyolefin plastomer, polypropylene + polyolefin plastomer; The inner layer is composed of raw materials in the following mass percentages: 70% - 95% of polypropylene, 5% - 30% of polyolefin plastomer, and its thickness is 30 - 50 μm; The middle layer is composed of raw materials in the following mass percentages: 40% - 60% of polyethylene, 40% - 60% of polyolefin plastomer, and its thickness is 110 - 150 μm; The outer layer is composed of raw materials in the following mass percentages: 80% - 95% of polypropylene, 5% - 20% of polyolefin plastomer, and its thickness is 20 - 50 μm.

[0008] The polypropylene used in the inner layer of the co-extruded infusion film with a three-layer structure has a melting point between 120 - 145 °C and a density of 0.85 - 0.91 g / cm 3 , and its melt index (230 °C / 2.16 kg) is 1.0 - 7.0 g / 10 min; the polyolefin plastomer has a melting point between 60 - 130 °C and a density of 0.89 - 0.92 g / cm 3 . The main function of this layer is to provide good drug compatibility, low precipitation, low adsorption, and a relatively wide heat-sealing temperature range.

[0009] The polyethylene used in the middle layer of the co-extruded infusion film with a three-layer structure has a melting point between 80 - 130 °C and a density of 0.90 - 0.92 g / cm 3 , and its melt index (190 °C / 2.16 kg) is 0.5 - 3.0 g / 10 min; the polyolefin plastomer has a melting point between 60 - 130 °C and a density of 0.89 - 0.92 g / cm 3 . The main function of this layer is to provide barrier properties, flexibility, good transparency, good low-temperature properties, and good mechanical properties.

[0010] The polypropylene used in the outer layer of the co-extruded infusion film with a three-layer structure has a melting point between 155 - 180 °C and a density of 0.88 - 0.91 g / cm 3 , and its melt index (230 °C / 2.16 kg) is 4.0 - 8.0 g / 10 min; the polyolefin plastomer has a melting point between 60 - 130 °C and a density of 0.89 - 0.92 g / cm 3, the melt index (190°C / 2.16 kg) is 0.5 to 4.0 g / 10 min. The main functions of this layer are to provide the weather resistance, barrier property, heat resistance during high-temperature sterilization and heat sealing, and good mechanical properties of the bag.

[0011] The polyolefin plastomer is one or more of PL1880G, PL1888G or PL1850G.

[0012] The total thickness of the three-layer coextruded film is 160 to 250 μm.

[0013] The present invention also provides a method for preparing a three-layer non-PVC coextruded infusion film, comprising the following steps: Step 1, respectively draw the raw materials of each layer into the hoppers of each extruder. The feeding screw of the hopper feeds according to the preset mass percentage, conveys the plastic particles to the mixing hopper, and after mixing, enters each heating section of the extruder. By controlling the heating temperature of each section of the extruder, the plastic particles are melted and plasticized to obtain molten mixtures respectively. Step 2, filter out impurities from the completely plasticized molten mixtures through a filter screen, and at the same time extrude them through a connecting pipe and a die head respectively. Control the rotation speed of each extruder respectively, and the three layers are compounded together at the die head to form a three-layer coextruded film.

[0014] The heating temperatures of the 9th zone of the outer layer extruder in Step 1 are respectively: 50 to 60°C, 170 to 190°C, 190 to 210°C, 210 to 220°C, 210 to 230°C, 210 to 230°C, 210 to 230°C, 210 to 230°C, 210 to 230°C; The heating temperatures of the 8th zone of the middle layer extruder are respectively: 50 to 60°C, 170 to 190°C, 190 to 210°C, 210 to 220°C, 210 to 230°C, 220 to 240°C, 220 to 240°C, 220 to 240°C; The heating temperatures of the 9th zone of the inner layer extruder are respectively: 50 to 60°C, 170 to 190°C, 190 to 200°C, 210 to 220°C, 220 to 230°C, 220 to 230°C, 230 to 240°C, 230 to 240°C, 230 to 240°C.

[0015] In Step 2, the specific control of the rotation speed of each extruder is: the outer layer extruder: 20 to 50 revolutions per minute, the middle layer extruder: 40 to 80 revolutions per minute, and the inner layer extruder: 20 to 50 revolutions per minute.

[0016] Three layers are compounded together by a flat stack die. The temperature of the flat stack die is 200~220°C. After being extruded by the flat stack die, a downward blown film bubble is formed by clean air. The blow-up ratio is between 1.5 and 2, the blowing pressure is 0.4 MPa~0.8 MPa, the cooling water temperature is 15°C~30°C, and the flow rate is 0000 L / h~3000 L / h. The film bubble is cooled by clean air and purified water. After being folded and flattened, it enters the winder for winding.

[0017] Compared with the existing multi-layer co-extruded infusion film, the beneficial effects of the present invention are as follows: (1) The three-layer structure adopted by the present invention has better flexibility compared with the traditional three-layer co-extruded infusion film. Even in an environment below 0°C, the film still has good softness, puncture resistance and impact resistance.

[0018] (2) The three-layer structure adopted by the present invention has good low-temperature resistance of the traditional five-layer co-extruded infusion film while having a relatively simpler structure and lower process requirements compared with the traditional five-layer co-extruded infusion film.

[0019] (3) By adding a polyolefin plastomer to the three-layer structure, the present invention improves the compatibility of polyethylene and polypropylene, and the three-layer structure can be successfully compounded without using an adhesive, and has excellent mechanical properties. Detailed implementation mode

[0020] The implementation scheme of the present invention will be described in detail below in conjunction with the embodiments. The following embodiments are only used to illustrate the present invention and should not be regarded as limiting the scope of the present invention.

[0021] The preparation method of the three-layer non-PVC co-extruded infusion film provided by the present invention is as follows: Step 1, respectively draw the raw materials of each layer into the hoppers of each extruder. The feeding screw of the hopper feeds according to the preset mass percentage, conveys the plastic particles to the mixing hopper, and after mixing, enters each heating section of the extruder. The plastic particles are melted and plasticized by controlling the heating temperature of each section of the extruder to obtain molten mixtures respectively. Step 2, filter out impurities from the completely plasticized molten mixture through a filter screen, and at the same time extrude through a connecting pipe and a die respectively. Control the rotation speed of the extruder respectively, and the three layers are compounded together at the die orifice to form a three-layer co-extruded film.

[0022] The heating temperatures of the 9th zone of the outer layer extruder in Step 1 are respectively: 50~60°C, 170~190°C, 190~210°C, 210~220°C, 210~230°C, 210~230°C, 210~230°C, 210~230°C, 210~230°C; The heating temperatures of the 8 zones of the middle layer extruder are respectively: 50 - 60 °C, 170 - 190 °C, 190 - 210 °C, 210 - 220 °C, 210 - 230 °C, 220 - 240 °C, 220 - 240 °C, 220 - 240 °C; The heating temperatures of the 9 zones of the inner layer extruder are respectively: 50 - 60 °C, 170 - 190 °C, 190 - 200 °C, 210 - 220 °C, 220 - 230 °C, 220 - 230 °C, 230 - 240 °C, 230 - 240 °C, 230 - 240 °C.

[0023] The specific control of the extruder speeds described in Step 2 is as follows: outer layer extruder: 20 - 50 revolutions per minute, middle layer extruder: 40 - 80 revolutions per minute, inner layer extruder: 20 - 50 revolutions per minute.

[0024] After the raw materials are extruded by the extruder screw, they are redistributed and extruded through the die head. The die head temperature is 200 - 220 °C; a flat stack die head is used. After extrusion through the die head, a downward blown film bubble is formed by clean air. The blow-up ratio is between 1.5 and 2, the blowing pressure is 0.4 MPa - 0.8 MPa, the cooling water temperature is 15 °C - 30 °C, and the flow rate is 0000 L / h - 3000 L / h; the film bubble is cooled by clean air and purified water. After being folded and flattened, it enters the coiler for coiling.

[0025] Examples 1 - 4 The outer layer with a thickness of 20 - 50 μm is composed of the following raw materials by mass percentage: 90% polypropylene, 10% polyolefin plastomer; among them, the melt flow rate of polypropylene measured according to GB-T3682 at 230 °C / 2.16 Kg is 7.0 g / 10 min; the polyolefin plastomer is selected as PL1850G; The middle layer with a thickness of 110 - 150 μm is composed of the following raw materials by mass percentage: 50% polyethylene, 50% polyolefin plastomer; among them, the melt flow rate of polyethylene measured according to GB-T3682 at 190 °C / 2.16 Kg is 1.0 g / 10 min; the polyolefin plastomer is selected as PL1880G; The inner layer with a thickness of 30 - 50 μm is composed of the following raw materials by mass percentage: 95% polypropylene, 5% polyolefin plastomer; among them, the melt flow rate of polypropylene measured according to GB-T3682 at 230 °C / 2.16 Kg is 7.0 g / 10 min; the polyolefin plastomer is selected as PL1880G.

[0026] The specific implementation situation is shown in Table 1.

[0027] Table 1 Thickness of each layer in Examples 1 - 4

[0028] Example 5 Different from Example 1, the raw materials of the middle layer are 60% polyethylene and 40% polyolefin plastomer; among them, the polyolefin plastomer is selected as PL1880G + PL1888G, and the mass ratio of PL1880G to PL1888G is 3:1. The rest is the same as Example 1.

[0029] The polyolefin plastomers used in the above Examples 1-5 are all from Dow Chemical Company, USA, with a melting point between 60 and 130 °C and a density of 0.89-0.92 g / cm 3 , and the melt index is 0.5-4.0 g / 10 min under the condition of 190 °C / 2.16 kg.

[0030] Some properties of the film were tested according to the national standard YBB00112005-2015, and the relevant properties are shown in Table 2.

[0031] Table 2 Film property test results of Examples 1-5

[0032] Note: 1. The refrigerated leakage rate in the table was measured with reference to Q / FH.JS2.376. Among them, the refrigerated leakage rate 1 medicine bag specification is 500 ml, the refrigerated leakage rate 2 medicine bag specification is 2000 ml, and the refrigerated leakage rate (2000 ml) of the traditional three-layer film is generally about 50%; 2. The samples used for the refrigerated leakage rate in the table were obtained by steaming and sterilizing the film material bags at 121 °C.

[0033] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, any modifications, equivalent substitutions, and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A non-PVC co-extruded infusion film with a three-layer structure, characterized in that, It has a three-layer structure, consisting of an inner layer, a middle layer, and an outer layer from the inside out; by mass percentage, the raw material of the inner layer is 70% - 95% polypropylene and 5% - 30% polyolefin plastomer, with a thickness of 30 - 50 μm; the raw material of the middle layer is 30% - 60% polyethylene and 40% - 70% polyolefin plastomer, with a thickness of 110 - 150 μm; the raw material of the outer layer is 80% - 95% polypropylene and 5% - 20% polyolefin plastomer, with a thickness of 20 - 50 μm.

2. The non-PVC co-extruded infusion film with a three-layer structure according to claim 1, characterized in that, The polypropylene used for the inner layer has a melting point of 120~145°C and a density of 0.85~0.91 g / cm 3 , and a melt index of 1.0~7.0 g / 10 min under the conditions of 230°C / 2.16 kg.

3. A non-PVC co-extruded infusion film with a three-layer structure according to claim 1, characterized in that, The polyethylene used in the intermediate layer has a melting point of 80~130°C and a density of 0.90~0.92 g / cm 3 , and a melt index of 0.5~3.0 g / 10 min under the conditions of 190°C / 2.16 kg.

4. A non-PVC co-extruded infusion film with a three-layer structure according to claim 1, characterized in that, The polypropylene used for the outer layer has a melting point of 155~180°C and a density of 0.88~0.91 g / cm 3 , and a melt index of 4.0~8.0 g / 10 min under the conditions of 230°C / 2.16 kg.

5. A non-PVC co-extruded infusion film with a three-layer structure according to claim 1, characterized in that, The polyolefin plastomer has a melting point of 60 to 130 °C and a density of 0.89 to 0.92 g / cm 3 , and a melt index of 0.5 to 4.0 g / 10 min under the conditions of 190 °C / 2.16 kg.

6. A non-PVC co-extruded infusion film with a three-layer structure according to claim 1, characterized in that, The polyolefin plastomer is one or more of PL1880G, PL1888G, or PL1850G.

7. A method for preparing a non-PVC co-extruded infusion film with a three-layer structure, characterized in that, It includes the following steps: Step 1, respectively pump the raw materials of each layer into the hoppers of each extruder. The feeding screw of the hopper feeds according to the preset mass percentage, conveys the plastic particles to the mixing hopper, and after mixing, enters each heating section of the extruder. By controlling the heating temperature of each section of the extruder, the plastic particles are melted and plasticized to obtain molten mixtures respectively; Step 2, filter out impurities from the completely plasticized molten mixtures through a filter screen, and at the same time extrude them respectively through connecting pipes and a die head. Control the rotation speed of each extruder respectively, and the three layers are compounded together at the die orifice to form a three-layer coextruded film.

8. The preparation method of the non-PVC co-extruded infusion film with a three-layer structure according to claim 7, characterized in that, The heating temperatures of the 9th zone of the outer layer extruder in Step 1 are respectively: 50 - 60 °C, 170 - 190 °C, 190 - 210 °C, 210 - 220 °C, 210 - 230 °C, 210 - 230 °C, 210 - 230 °C, 210 - 230 °C, 210 - 230 °C; The heating temperatures of the 8th zone of the middle layer extruder are respectively: 50 - 60 °C, 170 - 190 °C, 190 - 210 °C, 210 - 220 °C, 210 - 230 °C, 220 - 240 °C, 220 - 240 °C, 220 - 240 °C; The heating temperatures of the 9th zone of the inner layer extruder are respectively: 50 - 60 °C, 170 - 190 °C, 190 - 200 °C, 210 - 220 °C, 220 - 230 °C, 220 - 230 °C, 230 - 240 °C, 230 - 240 °C, 230 - 240 °C.

9. The preparation method of the non-PVC co-extruded infusion film with a three-layer structure according to claim 7, characterized in that, In Step 2, the specific control of the rotation speed of each extruder is as follows: the outer layer extruder: 20 - 50 revolutions per minute, the middle layer extruder: 40 - 80 revolutions per minute, the inner layer extruder: 20 - 50 revolutions per minute.

10. The preparation method of the non-PVC co-extruded infusion film with a three-layer structure according to claim 7, characterized in that, The three layers are compounded together using a flat stacking die head. The temperature of the flat stacking die head is 200 - 220 °C. After extrusion through the flat stacking die head, a downward blown film bubble is formed by clean air. The blow-up ratio is between 1.5 and 2, the blowing pressure is 0.4 MPa - 0.8 MPa, the cooling water temperature is 15 °C - 30 °C, and the flow rate is 0000 L / h - 3000 L / h; the film bubble is cooled by clean air and purified water. After folding and leveling, it enters the winder for winding.

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