| 袁怡,付蒙,胡敏.冻干胶塞水分测定方法及影响因素的研究[J].中国药品标准,2018,19(5):403-408 |
| 冻干胶塞水分测定方法及影响因素的研究 |
| Study on the Determination of Moisture Content of Lyophilized Halogenated Butyl Rubber Stopper and Its Influencing Factors |
| 投稿时间：2018-05-21 修订日期：2018-09-25 |
| DOI： |
| 中文关键词: 冻干胶塞 水分 测定方法 |
| 英文关键词: freeze-dried rubber stoppers Moisture content determination method |
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| 中文摘要: |
| 摘要 目的：比较并探讨冻干胶塞水分的测定方法，考察影响胶塞水分的因素。方法：通过比较不同检测方法的检测原理、取样方式、干燥方式，统一采用卡式炉-库仑法测定70批冻干胶塞样品中水分，并考察胶塞处理过程与储存环境对水分的影响。结果：该方法属于库仑滴定法，灵敏度和准确性较高；与干燥失重法相比，更具有专属性；与ISO方法进行配对T检验和回归分析，结果具有一致性。结论：该方法采用250℃条件下的永停滴定法，取样方式不受胶塞部位和切割方式的影响，能简便快速的测得胶塞中的水分。 |
| 英文摘要: |
| Abstract: Objective To compare and explore the method of determining the moisture content of freeze-dried rubber stoppers and investigate the factors affecting the moisture of rubber stoppers.MethodBy comparing the detection principle, sampling method and drying method of different detection methods, the moisture in 70 freeze-dried rubber stopper samples was measured by the cassette furnace-coulometric method, and the influence of the rubber stopper treatment process and storage environment on moisture was investigated. Result The method is a Coulomb titration with high sensitivity and accuracy，Itiwas more specific than the dry weight loss method. Paired T-test and regression analysis with the ISO method showed consistent results. Conclusion This method is based on the eternal stop titration method at 250°C. The sampling method is not affected by the position of the rubber stopper and the cutting method. Accuracy, precision and specificity are good. The moisture in the rubber stopper can be measured simply and quickly. |
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