Medicinal composite ointment quality control and detection method
The medicinal composite ointment tube is mainly used for holding ointment, and its quality is directly related to the quality of the medicine. At present, the commonly used materials for the composite medicinal ointment tube are polyethylene/aluminum/polyethylene three-layer structure, according to the “Publication Plan for the Issuance of the 2005 Standard Package (Repair) of the Pharmaceutical Packaging Materials issued by the State Food and Drug Administration†to YBB00252002 Revised, the revised implementation standard number is YBB00252005. According to the standard, the medicinal composite ointment tube testing items mainly include pressure strength testing, inner and inner peel strength testing, tensile strength testing, body heat sealing strength testing, sealing testing, and barrier performance testing (water vapor transmission and Oxygen permeation amount and other indicators. In order to facilitate the ointment and packaging enterprises to better understand the requirements of YBB00252005 for quality inspection, Jinan Languang Electromechanical Technology Co., Ltd. combined with the actual laboratory testing experience of Labthink and the corresponding testing instruments are as follows:
Ointment tube pressure strength test:
1. Test purpose: Since the composite hose is a composite film, the film is formed into a tube by a heat sealing process. If the process is unstable, it is easy to have a problem of strength drop and leakage.
Test method: take the sample, tighten the cap, torque 30N.cm-90N.cm, add compressed air from the end of the tube, air pressure is 0.2Mpa, put in water, continue to pressurize for 30 seconds, no cracking, and weld There should be no bubbles at the place.
Testing equipment: Use the NJY-20 torque meter of Jinan Languang Electromechanical Technology Co., Ltd. (Labthink) to tighten the cap of the ointment tube, and it is required that the tightening force should not be lower than 30N.cm. Then, the tail of the ointment tube was pierced with the collet of the LSSD-01 leaking and sealing strength tester, and placed in a special container (with water), and then 200 Kpa of air was introduced according to the standard to detect the leakage amount within 30 seconds.
Peel strength detection of inner and inner layers of ointment tube
Test purpose: Since the inner layer and the aluminum layer are combined by the bonding method, the detection of the peeling strength of the inner layer and the inner layer is an important parameter for determining the composite state, so the test is required.
Test method: The sample is tested according to the requirements of YBB00102003 standard. Note that the longitudinal and transverse peel strengths shall not be less than 5N/15mm. (Note that it must be the average of the peeling strength of the inner and inner layers, not the large value of zui)
Testing equipment: XLW series intelligent electronic tensile machine (labthink) can be used for inspection. The sample is taken to be 15mm wide, pre-stripped 50mm, and then clamped between the upper and lower fixtures of the intelligent electronic tensile testing machine. The speed was 300 mm/min, the test was started, and the test results were tested.
Ointment tube tensile strength test:
Test purpose: This indicator is an important indicator for judging the mechanical properties of materials.
Test method: According to the standard of YBB00112003, the longitudinal and transverse tensile strength should be tested separately, and the strength should not be lower than 16Mpa. Since the material is a composite material, the load of the * layer material when breaking can be recorded.
Test equipment: XLW series intelligent electronic tensile machine for inspection. Take the same batch of tubing, after sampling, clamp the specimen between the upper and lower clamps of the tensile machine, set the test speed to 100mm/min, and test the load when the * layer material breaks.
Body and tube heat sealing strength
Test purpose: Welding strength when the film is made into a tube
Test method: The test was carried out according to the YBB00122003 standard. It is required that the heat sealing strength of the pipe body is not less than 70N/15mm, and the heat sealing strength at the end of the pipe is not less than 20N/15mm.
Test instrument: The sample was uniformly cut into the width of 15 mm in the width direction. The two ends of the sample were placed on the XLW intelligent electronic tensile tester (labthink), and the test speed was set to 100 mm./min, and the test results were recorded.
Ointment tube barrier performance test
1. Test purpose: An important performance index considering the barrier properties of ointment tube material. It plays a key role in the control of hose tube permeability, rancidity, anti-discoloration, anti-hardening, oil-proof water separation.
2. Test method: The water vapor transmission rate is tested according to the method specified in YBB00092003. The test is required to bring the hot cover to the side with low humidity, and the water vapor transmission amount should not exceed 0.5g/m2.24h. The oxygen permeation amount is tested according to the YBB00082003 standard. The hot cover shall face the low pressure side during the test, and the oxygen permeation shall not exceed 0.5cm3/m2.24h.0.1Mpa.
The test instruments are tested by Labthink Blue's TSY-T series moisture permeability tester and VAC-V series differential pressure gas permeation tester. The instrument is fully automatic and highly accurate, and the test efficiency is greatly improved.
The above information is specially arranged by Jinan Languang Electromechanical Technology Co., Ltd. , in order to help the quality control of medicinal composite ointment tube manufacturing and use enterprises. At the same time, our company also has a professional laboratory to carry out the testing of all the above projects, hoping to Industry colleagues exchanged more questions.
For more information, please call Zhang Jianbo (), headquarter of Jinan Languang Electromechanical Technology Co., Ltd.
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