Study On The Compatibility Of Qingrejiedu Oral Liq With PET/AL/PE Composite Film For Drug Packaging

Qingre-jiedu oral liquid occupies a large proportion in the market and has been highly praised by the general public and its’ sales packaging is glass bottles.There are many shortages like the relatively high cost than the other packing.Before using them,a complex filling processes such as cleaning,disinfection,drying,filling,and capping are required.And it’s heavy,fragile,and very inconvenient to transport.Polyester/aluminum/polyethylene pharmaceutical packaging composite film is a composite film made of polyester,aluminum and polyethylene.It is a composite film packaging material that is widely used in the market and has better barrier properties.This paper mainly studies that according to the State regulations,if the polyester/aluminum/polyethylene pharmaceutical packaging composite film for packaging Qingre-Jiedu oral liquid would be changed of the original packaging material,it requires "compatibility study between medicines and pharmaceutical packaging materials".The purpose of this study is to investigate the compatibility of polyester/aluminum/polyethylene drug packaging composite film packaging Qingre-Jiedu oral liquid by establishing extraction test,migration test and adsorption test,and to explore polyester/aluminum/polyethylene drugs whether the packaging composite film can replace the original pharmaceutical packaging material for mass production.This type of composite material may be added with additives such as antioxidants,degradation products,lubricants,semi-volatiles,and other additives during the production,which can effectively improve its physical and chemical properties,but may also affect the drugs in contact with it’s quality and safety.Secondly,the printed ink contains heavy metals,and the composite film contains other metal elements introduced by aluminum in the production process,all of which have potential safety hazards.First of all,this experiment has carried out methodological verification in the extraction experiment,which verifies the scientific validity of the experimental method.Subsequently,the polyester/aluminum/polyethylene composite film for pharmaceutical packaging was extracted with a suitable solvent to obtain possible extracted semivolatile species,and the semivolatiles were determined by gas chromatography-mass spectrometry.The metal elements were digested by microwave,and the ICP-MS method was used to determine the metal elements.Secondly,in the migration test,this paper investigates the leaching amount of semivolatiles and metal elements in the polyester/aluminum/polyethylene composite film for pharmaceutical packaging after long-term storage of Qingre-Jiedu oral liquid through accelerated and long-term tests.Gas chromatography-mass spectrometry and ICP-MS methods were used to determine the migration of semivolatiles and metal elements.Under accelerated and long-term test conditions,the presence of semi-volatiles and metal elements was not detected in the placed Qingre-Jiedu oral liquid,the semi-volatiles and metal elements in the polyester/aluminum/polyethylene composite film for pharmaceutical packaging did not migrate To Qingre-Jiedu oral liquid.Finally,in the adsorption test,under the condition of the stability test of Qingre-Jiedu oral liquid,the glass bottle packaged Qingre-Jiedu oral liquid was used as a control group.Under the conditions of high temperature,high humidity and light in a long-term test,to test the properties,pH and content of baicalin in Qingrejiedu Oral Liquid,the content of baicalin was determined by high performance liquid chromatography to compare whether the content decreased.The adsorption test shows that all the items under investigation are in compliance with the regulations.According to the research results,the extraction and detection methods of semi-volatiles and inorganic elements are reliable,and the composite film of polyester/aluminum/polyethylene pharmaceutical packaging and Qingre-Jiedu oral liquid have no mutual influence and have good compatibility.Therefore,the oral liquid for clearing heat and detoxification can be packaged with the polyester/aluminum/polyethylene composite film for pharmaceutical packaging,and mass-produced to bring economic benefits to the enterprise.