Composite hard sheet for solid drug package and its preparation method

[0018] The barrier property of aluminum foil is very good, not light, moisture, and air. However, due to the purity of aluminum and the rolling environment, the quality of aluminum foil will be affected. When the aluminum foil is rolled below 0.015mm, pinholes tend to appear. The more pinholes, the larger the pore size, the greater the permeability and the worse the barrier property. Since the thickness of the aluminum foil is thinner, the packaging performance is worse, but the calendering cost of the aluminum foil is high. Combined with the purpose of the present invention, it is to provide a kind of high-grade medicine. Packaging material, so the thickness of aluminum foil is 0.055mm.

[0019] The concrete processing process of the product of the present invention is as follows:

[0020] 1. The polyurethane glue and the polyurethane glue ester are strictly formulated into a polyurethane adhesive according to the weight ratio of 100:20, and stir evenly. The diluent is the organic solvent ethyl acetate. The equipment adopts a 1000mm dry lamination unit. The main raw materials of the process are: aluminum foil, polyamide film, polyvinyl chloride film, polyurethane adhesive (PU glue).

[0021] 2. Lamination of polyamide film and aluminum foil Put the polyamide film in the first unwinding part, and follow the path of the production line; put the aluminum foil in the second unwinding part, combine it with the polyamide film to the winding part,

[0022] 3. Lamination of the other side of the aluminum foil with polyvinyl chloride The polyvinyl chloride film is again laminated to the other side of the aluminum foil.

[0023] The composite temperature of the above 2 and 3 composite processes is 65°C; the composite pressure is 2kgf; the unit speed is less than or equal to 100m/min.

[0024] 4. The curing process is to cure the polyurethane adhesive (PU glue) and improve the peel strength between the composite films. The production equipment is a constant temperature hot air blower, the constant hot air temperature is 60 °C, and the curing time is 48-72h.

[0025] In addition, the aspects that need to be paid attention to in the implementation of the present invention include:

[0026] 1. Various films must be controlled, such as polyamide film, polyvinyl chloride film, etc., which are easy to absorb moisture. When polyamide film and polyvinyl chloride film are wrinkled, they may have absorbed moisture. In this case, wrap the film with metal aluminum foil or film with good barrier properties and place it on the shelf in a dry environment, and avoid stacking it directly on the ground.

[0027] 2. The amount of water and alcohol in the solvent ethyl acetate used must be controlled, and the solvent from regular channels should be purchased as much as possible, and it should be stored in an airtight manner. To detect the water content of ethyl acetate, a method can be used to mix half of ethyl acetate and half of toluene to detect the water content of ethyl acetate. If the moisture content is too high, a quick moisture indicator can also be used to detect the moisture content.

[0028] 3. The composite environment must be controlled. The specific composite environment of the present invention is a 300,000-level purification workshop. An exhaust fan is placed indoors to enhance indoor air circulation, but be careful not to blow against the composite machine, and check the guide roller, composite roller and net. If there are water beads on the roller, wipe it with a dry towel.

[0029] 4. When preparing the adhesive, the amount of the compound should be appropriately reduced, and it should be used as needed. Do not leave it for too long. At the same time, when preparing the adhesive, ensure that the amount of polyurethane resin is as high as possible. The amount of urethane gum ester (5-10%) increases the degree of cross-linking between the polyurethane glue and the urethane gum ester.

[0030] 5. Change the process parameters of the compound machine. At present, most of the domestic compound machines have small air outlets. During compounding, the air inlet speed is higher than the air outlet speed, so that a high air pressure is formed in the drying tunnel, which is easy to slow down the evaporation rate of the solvent and make compounding. The residual solvent of the film is increased. Therefore, the air outlet pipeline is enlarged. In addition, if the air outlet pipeline is long, an induced draft fan should be installed directly at the outlet of the air outlet. Generally, imported compound machines have this device. In this way, the air outlet speed is greater than the shelter speed, so that a low pressure is formed in the drying tunnel, which is suitable for solvent volatilization and reduces residual solvent. In addition, if the temperature in the drying tunnel can be increased, it should be increased as much as possible (note that the first zone should not be too high—that is, the film feeding zone).

[0031] 6. When compounding, pay attention to the scraper and guide roller near the glue tank at any time, whether there is water droplets, and reduce the speed at the same time, because the speed of the vehicle is too fast, the solvent volatilization speed in the glue tank is accelerated, and the local temperature near the glue tank is too low, which directly causes Water vapor condenses.

[0032] The performance measuring method and measured value of the present invention and the comparison with the national quality standard of similar products:

[0033]A. Unless otherwise specified, the water vapor transmission rate shall be carried out according to the cup method (GB1037-88) of the test method for water vapor permeability of plastic films and sheets. During the test, the polyvinyl chloride faces the side with low humidity, the test temperature is (38±2)℃, the relative humidity is (90±5)%, and the measured value of the present invention is not more than 0.1g/m 2 ×24h, and the national quality standard is no more than 0.5g/m 2 ×24h.

[0034] B. Unless otherwise specified, the oxygen transmission rate shall be carried out according to the regulations of the gas permeability test method of plastic films and sheets (pressure difference method GB/T1038-2000). During the test, the polyvinyl chloride faces the low-pressure side of oxygen, and the test temperature is (23±2) °C, and the measured value of the present invention is not more than 0.2cm 3 /m 2 ×24h×0.1Mpa, and the national quality standard is no more than 0.5cm 3 /2×24h×0.1Mpa.

[0035] C. Peel strength Take an appropriate amount of film, remove 50mm from both ends of the sample in the width direction, and evenly cut 5 samples with a width of 15mm in the longitudinal and transverse directions along the width direction (the composite direction is the longitudinal direction). Along the length of the sample, peel the composite layer from the substrate for 50mm in advance, and the peeled part must not have obvious damage. If the sample is not easy to peel off, one end of the sample can be immersed in a suitable solvent (usually ethyl acetate) for about 20mm, and then peel off after the solvent is completely evaporated. The sample should be placed in an environment with a temperature of (23±2)°C and a relative humidity of (50±5)% for more than 4 hours, and the test should be carried out under the above conditions. The peeled ends of the sample are clamped in the upper and lower clamps of the testing machine respectively, so that the longitudinal axis of the peeled part of the sample coincides with the center line of the upper and lower clamps, and the tightness is appropriate. The test speed is (300±30)mm/ min, the tensile direction and the unpeeled part are T-shaped, and each peel strength value is recorded. The peel strength between polyamide/aluminum layers shall not be lower than 8.0N/15mm; the peel strength between aluminum/polyvinyl chloride layers shall not be lower than 7.0N/15mm. (If the composite layer cannot be peeled off or the composite layer is segmented, its peel strength is qualified), the composite layer of the sample of the present invention cannot be peeled off.

[0036] D. Cut out 2 test pieces of 100mm×100mm for heat sealing strength. Lay the polyvinyl chloride surface of the composite rigid sheet with the same size aluminum foil for standard drug packaging, and heat it on a heat sealer. The heat sealing temperature is 155℃±5℃ , pressure 0.2Mpa, time 1 second. Cut a sample with a width of 15mm from the heat-sealing part, and take the middle 3 strips for testing. test under conditions. Taking the heat sealing part as the center line/opening at 180°, clamp both ends of the sample on the two clamps of the testing machine. The axis of the sample coincides with the center line of the upper and lower clamps, and the tension is appropriate. The distance between the clamps is 50mm. The speed is (300±30)mm/min, and the maximum load when the sample is broken is read. The national quality standard is that the average value of the heat sealing strength of the 6 samples shall not be lower than 6.0N/15mm. The average value of the heat-sealing strength of the 6 samples of the present invention is 8.6 N/15mm.