Summary: The medicinal plastic bottle is gradually replacing the medicinal glass bottle because of its advantages of light weight, high strength, good sealing and pressure resistance, and is widely used in the packaging field of oral solid medicine and liquid medicine. However, due to the complex composition of the drug, the different properties, and the harsh storage conditions, the requirements for plastic bottles are also stricter. The introduction of the corresponding standards means that enterprises need to strictly implement the quality monitoring and testing of pharmaceutical plastic bottles. This article will briefly introduce the barrier properties and sealing test methods for medicinal plastic bottles according to the standard requirements. Key words: medicinal plastic bottle, sealing, torsion, water vapor infiltration Author: Labthink Technology Co., Ltd. background: The quality and safety of medicines directly affect national health. As an important part of medicines, packaging plays an important role in quality protection after production. The medicinal plastic bottle is gradually replacing the medicinal glass bottle because of its advantages of light weight, high strength, good sealing and pressure resistance, and is widely used in the packaging field of oral solid medicine and liquid medicine. However, due to the complex composition of the drug, the different properties, and the harsh storage conditions, the requirements for plastic bottles are also stricter. The medicinal plastic bottles produced must pass the relevant tests of the quality department to ensure that the medicinal plastic bottles produced meet the national factory specifications, and ensure that there will be no quality accidents during the application of the medicines to ensure the safety of the medicines. In 2002 , China's State Drug Administration issued the national pharmaceutical packaging container standard for oral liquid pharmaceutical plastic bottles, respectively YBB00082002 "oral liquid pharmaceutical polypropylene bottle - trial version", YBB00092002 "oral liquid pharmaceutical high density polyethylene Bottle - Trial Version, YBB00112002 "Oral solid medicinal polypropylene bottle" and so on. The introduction of these standards means that companies need to strictly implement the quality monitoring and testing of pharmaceutical plastic bottles. At present, medicinal plastic bottles mainly use PP , HDPE and PET materials. This article will start from the standard requirements of the above-mentioned materials medicinal plastic bottles, and briefly introduce the barrier properties and sealing test methods of medicinal plastic bottles. Barrier performance test Barrier performance refers to the barrier effect of packaging materials on permeates such as gases and liquids. Test items include gas and water vapor transmission performance testing. Oxygen and water vapor are important factors affecting the quality of pharmaceuticals. If the barrier properties of medicinal plastic bottles are not good, it will inevitably lead to deterioration of the drug due to excessive oxygen and water vapor. This requires enterprises to use medicinal plastic bottles. Barrier performance is tested. Production of Labthink development density Bo PERME OX2 / 230 oxygen transmission rate test system, the test principle using pressure method and the like, through the container attachments included with the test, the detection of drugs can help businesses plastic bottle oxygen transmission rate indicator. The pre-treated blister sample is placed in the test chamber, oxygen flows on the outside of the medicinal plastic bottle, and high-purity nitrogen flows on the inside of the plastic bottle. Due to the presence of the oxygen concentration gradient, the oxygen molecules pass through the film from the plastic bottle. The outer side is diffused into the inner high-purity nitrogen gas, carried by the flowing nitrogen gas to the sensor, and the oxygen concentration measured by the sensor is analyzed to calculate the oxygen permeability and other parameters to evaluate the oxygen barrier performance of the test sample. . The OX2/230 equipment comes with constant temperature and humidity control function. The whole test process is controlled by computer and automatically tested. After the user only needs to clamp the sample, the test can be fully automated, and the test will be automatically judged and a test report will be issued. Water vapor permeability can be detected using PERME Bo adhesion W3 / 330 water vapor transmission rate test system is completed. The device adopts the principle of electrolytic sensor test, that is, the pre-treated medicinal plastic bottle is placed in the test chamber, nitrogen of a certain humidity flows on the outside of the plastic bottle, and high-purity nitrogen flows on the inner side of the plastic bottle due to the existence of a humidity gradient. The water vapor molecules diffuse through the film from the outside of the plastic bottle to the inside of the high-purity nitrogen gas, are carried to the sensor by the flowing nitrogen gas, and analyze the water vapor concentration measured by the sensor to calculate the water vapor transmission rate and other parameters. In order to evaluate the water vapor permeation of the test medicinal plastic bottle. Sealing test Sealing performance refers to the reliability of the medicinal plastic bottle seal, which ensures the integrity of the entire product package seal. In order to ensure that the drug is not exposed to moisture and quality during the validity period, the medicinal plastic bottle should have a good sealing property, and the relevant national standards have clearly defined this. Test method: Take a certain amount of medicinal plastic bottle, put a proper amount of glass beads in the bottle, and tighten the bottle cap with NJY-20 torque meter or force wrench. The torque value of the specific bottle cap refers to the following table: Cover diameter ( mm ) Torque ( N·cm ) 15~22 59~78 23~48 98~118 49~70 147~176 Then, the medicinal plastic bottle is placed in a container with a suction device, immersed in water, and vacuumed to a vacuum of 27 kPa for 2 minutes, and there is no water or bubbles in the bottle. Labthink 's MFY-01 seal tester, negative pressure vacuum test, the test process only needs to input the corresponding pressure value and time, the instrument can achieve fully automatic test, easy to operate. By vacuuming the vacuum chamber, the sample immersed in water is subjected to internal and external pressure difference, and the gas escape in the sample is visually observed to determine the sealing performance of the sample; the sample shape is recovered after the sample is expanded and the vacuum is released. In order to judge the overall sealing performance of the package. In summary, through the above tests, enterprises can monitor the barrier properties and sealing performance of medicinal plastic bottles; in addition, it is necessary to test and control the appearance and microbial indicators of plastic bottles. Through comprehensive quality monitoring, the production process is adjusted to ensure the quality of the product, thereby avoiding product quality problems caused by the quality of the packaging. Copyright statement: This article is copyrighted by Jinan Languang Electromechanical Technology Co., Ltd., and it is forbidden to reprint without permission! 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