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

Shuanghuanglian oral liquid（Shuanghuanglian oral liquid）is a clinical drug used for pneumonia,upper respiratory tract infection and other respiratory system infections.Its raw materials are skullcap,honeysuckle and forsythia.The commercially available Shuanghuanglian oral liquid is packaged in glass bottles.The glass bottles have stable chemical properties and good barrier properties,but the production cost is high,and they are easily damaged during transportation and are not easy to carry and use.Polyester/aluminum/polyethylene pharmaceutical composite film is a film made of polyester,aluminum and polyethylene through adhesives.It combines the advantages of various materials,with low price and high cost performance,and has been widely used in the market.Therefore,this thesis mainly studies the packaging material of the new polyester/aluminum/polyethylene composite film Shuanghuanglian oral liquid.Through extraction experiment,migration experiment,adsorption experiment,safety evaluation,etc.To evaluate the compatibility of polyester/aluminum/polyethylene pharmaceutical packaging composite film for packaging Shuanghuanglian oral liquid,and to explore whether polyester/aluminum/polyethylene pharmaceutical composite film can be used as the packaging form of Shuanghuanglian oral liquid for mass production.Because the polyester/aluminum/polyethylene pharmaceutical packaging composite film will have ink printing in the production process,the multi-layer film will be compounded with adhesives,and a large amount of organic solvents will be used in the coating process,the printed ink contains heavy metals,and the composite film Contains aluminum elements and other metal elements introduced by aluminum foils in the production of pipes and other equipment,all of which have safety problems.Therefore,in the extraction experiment,firstly,research on the detection methodology of semi-volatiles and inorganic elements was carried out.The microwave extraction method was used to extract the polyester/aluminum/polyethylene pharmaceutical packaging composite film with a suitable solvent to obtain semi-volatile substances that may be dissolved.species to determine the feasibility of semivolatiles determination using gas chromatography-mass spectrometry.Microwave digestion of metal elements was carried out,and it was confirmed that the ICP-MS method had good sensitivity,repeatability and accuracy for the detection of metal elements.Phenol,naphthalene,N-nitroso diphenylamine and dibutyl phthalate were not detected in the packaging material extract,pH 5.0 and pH 7.0 phosphate extract.In the packaging material extract,the metal element content meets the quality requirements of the oral liquid directly contacting the packaging material.In terms of migration experiments,this study investigated the leaching amount of semi-volatiles and inorganic elements in the packaging materials of Shuanghuanglian oral liquid under long-term storage conditions through accelerated tests and long-term tests.Detection,use ICP-MS method to detect and analyze the metal elements in the packaging materials.It was found that no semi-volatiles and metal elements were detected in Shuanghuanglian oral liquid placed under accelerated test conditions and long-term test conditions,and semi-volatiles and metal elements in polyester/aluminum/polyethylene pharmaceutical packaging composite film did not migrate To Shuanghuanglian oral liquid.In terms of adsorption experiments,based on the stability experimental conditions of shuanghuanglian oral liquid,the glass bottle shuanghuanglian oral liquid was used as a parallel control.Under the conditions of accelerated test and long-term test,the changes in the properties,inspection and content of polyester/aluminum/polyethylene pharmaceutical composite film packaging double huanglian oral liquid were investigated.The content of baicalin and chlorogenic acid was determined by HPLC method without significant effect.Compared with the glass bottle of double huanglian oral solution,the slight change in content is consistent with it.And under the condition of special requirements,the water content of the oral liquid of double huanglian was determined by gravimetric method,and its moisture loss rate was not more than 5%,and polyester/aluminum/polyethylene pharmaceutical packaging had no obvious adsorption effect on double huanglian.The results show that the extraction and detection methods of semi-volatiles and inorganic elements are effective,scientific and feasible.There is no interaction between the polyester/aluminum/polyethylene composite film for pharmaceutical packaging and Shuanghuanglian oral liquid,and the compatibility is good.The polyester/aluminum/polyethylene composite film for pharmaceutical packaging can be used as the packaging of Shuanghuanglian oral liquid for large-scale production to improve enterprise benefits..