硫酸沙丁胺醇吸入气雾剂与药用气雾剂铝瓶相容性研究

Compatibility Between Salbutamol Sulfate Inhalation Aerosol and Pharmaceutical Aerosols Aluminum Bottle

目的探讨硫酸沙丁胺醇吸入气雾剂与药用气雾剂铝瓶的相容性。方法采用高效液相色谱法测定提取液与迁移液中抗氧剂和金属元素的含量,色谱柱为Symmetry C18柱(250 mm×4.6 mm,5μm),流动相为水-四氢呋喃-乙腈(1∶3∶6,V/V/V),流速为1.5 m L/min,检测波长为280 nm[抗氧剂1010、1076、168、330、2,6二叔丁基对甲酚(BHT)]、266 nm(抗氧剂168氧化物),进样量为20μL。结果阀体、罩杯和内垫圈提取液中抗氧剂1010、1076、168、168氧化物、330、BHT,以及阀体、罩杯、弹簧、阀芯、内垫圈、铝瓶提取液中铅、钡、铬、铜、镉、锡、镍元素的检出量均低于相应的分析评价阈值(AET);硫酸沙丁胺醇吸入气雾剂浸出物抗氧剂1010、1076、168、168氧化物、330、BHT,以及铅、钡、铬、铜、镉、锡、镍元素的检出量均低于相应的AET。结论药用气雾剂铝瓶可作为硫酸沙丁胺醇吸入气雾剂的包装材料。

Objective To investigate the compatibility between salbutamol sulfate inhalation aerosol and pharmaceutical aerosol aluminum bottle.Methods The content of antioxidant and metal elements in the extracted and migrating solution was determined by the high-performance liquid chromatography(HPLC).The chromatographic column was Symmetry C18 column(250 mm×4.6 mm,5μm),the mobile phase was water-tetrahydrofuran-acetonitrile(1∶3∶6,V/V/V),the flow rate was 1.5 m L/min,the detection wavelength was set at 280 nm for antioxidants 1010,1076,168,330 and 2,6-Di-tert-butyl-4-methylphenol(BHT),266 nm for antioxidant 168 oxide,and the injection volume was 20μL.Results The contents of antioxidants 1010,1076,168,168 oxide,330 and BHT in the extracts of the valve body,cup and inner gasket,and the contents of lead(Pb),antimony(Ba),chromium(Cr),copper(Cu),cadmium(Cd),tin(Sn)and nickel(Ni)in the extracts of the valve body,cup,spring,valve core,inner gasket and aluminum bottle were lower than the corresponding analytical evaluation threshold(AET).The contents of the antioxidants 1010,1076,168,168 oxide,330 and BHT,the Pb,Ba,Cr,Cu,Cd,Sn and Ni of the extracts of the salbutamol sulfate inhalation aerosol were lower than the corresponding AET.Conclusion The pharmaceutical aerosol aluminum bottle can be used as a packaging material for salbutamol sulfate inhalation aerosol.