Abstract : Drugs are easy to absorb water, deliquesce and deteriorate. The medicinal aluminum-plastic composite film should have high moisture resistance. The lower the water vapor transmission rate, the higher the moisture resistance of the packaging material and the good protection for the drugs. This article details the medicinal aluminum-plastic composite film rubbing test and how to monitor the moisture resistance of packaging materials before and after rubbing, to provide technical references for users in various industries.

Keywords : pharmaceuticals, aluminum-plastic composite film, rubbing properties, moisture barrier, moisture permeability, water vapor barrier, water vapor transmission rate, deliquescence deterioration

Test significance:

The safety of the drug itself is very important, so the performance requirements of the external packaging materials are also high, especially the barrier performance of the packaging material to the external water vapor, which can effectively prevent the drug from being deliquescent. Aluminum-plastic composite film packaging can be used as a powder medicine outer packaging bag or blister packaging bottom plate material. In addition to making the medicine packaging have a beautiful and good texture, the most important advantage is that it has extremely high barrier properties. The plastic film layer in the composite film also participates in gas permeability, and also has a certain effect on the overall barrier properties of the composite film, but it does not play a decisive role, unless the pinhole size of the aluminum foil is sufficiently large compared with the thickness of other composite layers, the composite film The barrier property will be significantly affected by the thickness of the plastic film and its barrier properties. In addition, the aluminum foil layer in the aluminum-plastic composite film is prone to a certain degree of creases during packaging molding, drug filling, heat sealing, transportation and sales, which deteriorates the barrier properties of the composite film and the overall sealing of the finished packaging is affected. Great influence.

Detection method:

The rubbing resistance test of the flexible composite film follows the standard of ASTM F392 "Test Method for Flexural Durability of Flexible Barrier Materials". A special rubbing tester is used to test the composite under standard atmospheric pressure conditions (23 ° C and 50% relative humidity). The film is rubbed up and down and repeatedly twisted. The rubbing conditions, frequency and rubbing intensity vary according to the material of the tested sample and the actual use process, but the frequency is fixed at a speed of 45 times / minute. We will use the FDT-02 rubbing tester independently developed by Labthink Languang Company in combination with the above standards to conduct a rubbing test on samples of medicinal aluminum-plastic composite films.

Common testing methods for moisture resistance of flexible plastic packaging are divided into weighing method (also known as cup method) and sensor method, in which sensor method is divided into electrolytic method, humidity method and infrared method. The weighing method is widely used as a basic method for the detection of water vapor transmission rate of pharmaceutical packaging materials. By accurately weighing a certain temperature and humidity environment, the sample is clamped with the sample after reaching the water vapor transmission equilibrium. The mass of the moisture-permeable cup changes before and after, thus calculating the water vapor transmission rate of the sample.

At present, the water vapor transmission rate test by the domestic weighing method follows the national standard GB1037-1988 "Test method for water vapor permeability of plastic films and sheets".

1. Test equipment

The FDT-02 rubbing tester developed by Labthink is equipped with five standard test modes. Four sample stations can easily realize combined tests under different conditions, and can quickly switch between long and short strokes. The instrument meets the ASTM F392 foreign standard, and can be applied to the anti-kneading performance test of flexible films, composite films, aluminum-plastic composite films, aluminized films, coating films and other materials under various purposes, simulating the film production, processing, Behaviors such as rubbing and crushing damage during transportation. After the rubbing test is completed, the anti-rubbing performance of the material is judged by detecting the change in the number of pinholes before and after the sample or the change in barrier performance.

W3 / 060 water vapor transmission rate test system, six-chamber independent, ultra-high test accuracy, can test six identical or different samples at the same time, temperature control range is 15 ℃ ～ 55 ℃, humidity control range is 10% RH ～ 98 % RH, water vapor transmission rate test range is (0.1 ～ 10,000) g / m2 • 24h, the system can support up to 10 instruments connected in parallel, and establish an efficient system for simultaneous testing of 60 samples. The instrument can meet the water vapor barrier of various plastic films, composite films, paper-plastic composite films, co-extruded films, aluminized films, aluminum foil, aluminum-plastic composite films, waterproof breathable films and other materials and sheets under different temperature and humidity environments. Sexual testing.

2. Sample preparation

Using the FDT-02 rubbing tester, the aluminum-plastic composite film sample was repeatedly rubbed 270 times in C mode for 6 minutes, and the rubbed sample and the unrubbed intact sample were placed in a 23 ° C environment and placed in a dryer. Adjust the state for 48 hours. After taking out the two samples before and after rubbing, three samples with a diameter of 74 mm were cut from each sample.

3. Test conditions

Location: Jinan Languang Packaging Safety Testing Center

Test temperature and humidity: 38 ℃, 90% RH

Test method: Weighing method (ie cup method)

4. Test procedure

4.1 Test principle

W3 / 060 adopts the test principle of the penetrating cup weighing method. At a certain temperature, a specific humidity difference is formed on both sides of the sample. Water vapor passes through the sample in the penetrating cup and enters the dry side. The amount of change of the weight of the moisture-permeable cup with time is used to obtain the parameters such as the water vapor transmission rate of the sample.

4.2 Sample clamping

Add a certain volume of distilled water to the moisture-permeable cup (generally between 1/2 and 2/3 of the water-filling height of the moisture-permeable cup), and prevent water from overflowing when moving or taking it; place a black rubber flat washer into the cup after adding water , Then put the composite membrane sample lightly (do not allow the sample to get wet, do not fold the sample to ensure full expansion); after placing the sample, place a black rubber flat washer; then put the white Teflon sealing ring , Put on the cup lid and tighten; after tightening, check whether the white circle and the black circle are tightly pressed, to ensure that the screw holes of the moisture-permeable cup and the cup lid are in good agreement.

4.3 Testing process

W3 / 060 automated test, the test process is simple:

Put the moisture-permeable cup holding the sample into the instrument as soon as possible, put it in the cup holder according to the sample number, close the test chamber door, and fasten the door buckle.

The test conditions were set to standard conditions, ie the test temperature was 38 ° C and the relative humidity was 90% RH.

Open the device software, set the test parameters, and start the test. Test parameters include control parameters (test mode, number of cycles, test interval, etc.) and sample parameters (name, number, material type, area, thickness, etc.).

End of the test and data processing. Turn off the power.

The water vapor transmission rates of the aluminum-plastic composite film samples without rubbing and rubbing were 0.0259g / m2 • 24h and 2.5037 g / m2 • 24h, respectively. The relative deviation of the test results between the three samples of each sample was less than 10 %, The relative average deviation is less than 5%. Therefore, the poor quality aluminum-plastic composite film has a large difference in moisture resistance before and after rubbing. After the finished product packaging is formed, the water vapor transmission rate is likely to increase significantly, resulting in the quality problem of deliquescent and deterioration of the drug.

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