中国药业2023，Vol.32Issue(23)：24-28,5.DOI:10.3969/j.issn.1006-4931.2023.23.005
真空衰减法测定劳拉西泮注射液的包装密封性
Detection of Closure Integrity of Lorazepam Injection by Vacuum Decay Method
摘要
Abstract
Objective To establish a vacuum decay method for the detection of closure integrity of Lorazepam Injection.Methods Positive samples with nominal pore sizes of 3,5,and 10 μm were prepared by laser drilling method,and intact products produced on the production line were taken as negative control samples.Vacuum decay method was used to study the closure integrity of Lorazepam Injection,and methodological validation was conducted.The established method was compared with the microbial challenge method to ensure that it was suitable for testing the closure integrity of Lorazepam Injection.Results The detection parameters for the vacuum decay method of the closure integrity of Lorazepam Injection were as follows:the vacuum degree was 5 mbar,and the holding time was 4.0 s(Cycle 1);the vacuum degree was 1.4 mbar,the holding time was 3.0 s,the testing time was 16.0 s,and the pressure relief time was 4.0 s(Cycle 2).The methodological validation results showed that the RSDs of the precision test was less than 10.0％;the leakage rate of positive samples of the accuracy and durability tests was 100.00％,while the leakage rate of negative control samples was 0.When the nominal pore sizes of the positive sample were 3,5,and 10 μm,the detection rates of the vacuum decay method were all 100.00％,and the detection rates of the microbial challenge method were 70.00％,90.00％,and 100.00％,respectively.The results of the 3-month accelerated test showed that the leakage rate of Lorazepam Injection was 0.Conclusion The established vacuum decay method is non-destructive,easy to operate,highly sensitive,and has accurate and reliable results.It can effectively detect leaks caused by microbial invasion and can be used for the detection of closure integrity of Lorazepam Injection.关键词
劳拉西泮注射液/真空衰减法/包装密封性Key words
Lorazepam Injection/vacuum decay method/closure integrity分类
医药卫生引用本文复制引用
高梓真,毛文星,周琪,金鑫,王佳瑜,许向阳..真空衰减法测定劳拉西泮注射液的包装密封性[J].中国药业,2023,32(23):24-28,5.基金项目
重庆市技术创新与应用发展专项资助项目[CSTB2022TIAD-GPX0071]. （）
