Study On Pharmaceutical Packaging Materials And Containers Of Quality Standards

A new type of oral liquid bottle made of polyester/low density polyethylene?LDPE?liquid composite hard Tabts is a new generation of soft packaging product developed in the packaging container of liquid pharmaceutical preparations on the basis of polyvinyl chloride/polyethylene liquid composite hard Tabts used in liquid pharmaceutical soft packaging.At present,the soft packaging products for oral liquid preparations are not included in the 2015 edition of the National Standards for Pharmaceutical Packaging Materials.Quality standard.However,the quality standard and safety research of oral liquid bottle made of polyester/low density polyethylene?LDPE?liquid and medicinal composite hard Tabts are also insufficient.Therefore,it is urgent to grasp the safety of oral liquid bottle made of polyester/LDPE liquid and medicinal composite hard Tabts,establish a scientific and effective quality standard and safety evaluation method,which will be helpful to the development and research of oral liquid soft packaging products.Halogenated butyl rubber stoppers for freeze-drying of injection are developed from halogenated butyl rubber stoppers for sterile powder for injection and used for sealing of freeze-drying preparations.The freeze-drying agent has strong moisture conductivity.The residual moisture in the rubber plug will affect the storage and use of the freeze-drying agent,because it is necessary to control the residual moisture in the freeze-drying rubber plug.A method for the analysis of harmful substances in oral liquid bottles made of new polyester/low density polyethylene?LDPE?liquid and medicinal composite hard Tabts was established by gas chromatography.Establishment of drying method and Karl Fischer method for determination of residual moisture in freeze-dried rubber plug.The main conclusions are as follows:1.In the study of headspace gas phase determination method for residual solvents in oral liquid bottles made of new polyester/low density polyethylene liquid composite hard Tabts,the following conclusions were obtained:HP-INNOWAX strong polar column was selected,the inlet temperature was 200?,the temperature of FID detector was 220?,the shunt ratio was 10:1,the nitrogen flow rate was 2 ml·min^-1,the hydrogen flow rate was 40 mL·min^-1,and the air flow rate was 200 mL·min^-1.The heating procedure is as follows:the initial temperature is 50?,which is maintained for5 minutes,and the temperature is raised from 10?·min^-1 to 150?which is maintained for 5 minutes.The optimum equilibrium temperature of headspace is 100?and the optimum equilibrium time is 60 min.Under the conditions,the 12 residual solvents showed good linearity in the range of 0.0036?g·ml^-15.5488?g·ml^-1,the correlation coefficients were greater than 0.9949,the quantitative limit was 0.0036?g·ml^-10.6936?g·ml^-1,the recoveries were between 83.31%and 106.55%,and RSD was between 1.98%and 9.06%.This method is used to determine the residual solvents in the oral liquid bottle made of new polyester/low density polyethylene?LDPE?liquid and medicinal composite hard Tabts.The analysis speed is fast and the separation effect is good.2.In the study of gas chromatographic determination of ethylene glycol and diethylene glycol in oral liquid bottle made of new polyester/low density polyethylene liquid composite hard Tabts,it is concluded that reflux extraction method can effectively extract ethylene glycol and diethylene glycol,the optimum extraction temperature is 100?,and the optimum extraction time is 4 hours.HP-INNOWAX strong polarity column was used to optimize the gas phase conditions.Pulse non-shunt injection was selected:the injection pulse pressure was 10 psi,the non-shunt time was0.75 min,and the flow rate at the shunt outlet was 60 ml·min^-1.the heating procedure was as follows:initial temperature was maintained at 45?for 1 min,at 50?·min^-1 to230 for 13 min;the inlet temperature was 230?and the detector temperature was260?,H₂ flow rate was 40 mL·min^-1,N₂ flow rate 39 ml·min^-1,air flow rate 450mL·min^-1.Under these conditions,the linear equations of ethylene glycol and diethylene glycol are Y_EG=3689.8X+2.24,Y_DEG=4053.2X+3.02,and the correlation coefficients are 0.9996 and 0.9934.The recoveries of the samples are 92.21%and99.15%,and the RSD are 3.85%and 4.76%.This method is suiTab for the determination of ethylene glycol and diethylene glycol in oral liquid bottles made of new polyester/low density polyethylene liquid composite hard Tabts.The method has good separation effect and sensitivity.3.In this paper,the migration of ethylene glycol and diethylene glycol in different polar simulation solutions was compared,and water,65%ethanol and n-hexane were selected as the simulation liquid,and ethylene glycol and diethylene glycol were found to be easy to migrate in the strong-grade aqueous solution.4.When drying method and Karl Fischer method were used to determine residual moisture of rubber plugs,it was found that the results of drying method after heating for 6 hours were similar to those of Karl Fischer method.It was suggested that the results of drying method after heating for 6 hours should be taken as the residual moisture value of freeze-dried rubber plugs.The weight loss ratio of residual moisture in 20 batches of rubber plugs was less than 0.5%.The results of drying method and Karl Fischer method were different.For large ones,the results of Karl Fischer's method should be taken as the criterion.