| 引用本文: | 王丹丹,金宏.真空度测定法检测冻干粉针剂包装密闭系统的密封与泄露[J].中国现代应用药学,2013,30(7):770-772. |
| WANG Dandan,JIN Hong.Leak of Freeze-dry Powder Injector Container Closure System by Vacuum Degree Measurement[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(7):770-772. |
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| 摘要: |
| 目的 建立真空度测定法检测冻干粉针剂包装密闭系统密封与泄露。方法 采用测定冻干粉针剂包装密闭系统真空度的方法考察冻干粉针剂包装密闭系统是否完好，且将该方法与着色液浸透法和水中减压法测定结果做比较。结果 真空度测定方法相比着色渗透法和水中减压法更灵敏，不仅能定性，还能定量检测冻干粉针包装密闭系统的密封或泄漏。结论 该方法快速、灵敏、简便、有效，为建立粉针剂包装密闭系统密封性检测方法提供了参考依据。 |
| 关键词: 真空度 冻干粉针剂 密封 |
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| Leak of Freeze-dry Powder Injector Container Closure System by Vacuum Degree Measurement |
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WANG Dandan, JIN Hong
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Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
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| Abstract: |
| OBJECTIVE To establish a method to test leak of freeze-dry powder injector container closure system by vacuum degree measurement. METHODS To test the leak of freeze-dry powder injector container closure system by vacuum degree measurement, and compare this method with dye penetrating and decompressing methods. RESULTS It is more sensitive to test leak of freeze-dry powder injector container closure system by vacuum degree measurement both qualitatively and quantitatively, compared with dye penetrating and decompressing methods. CONCLUSION This method is quick, sensitive, simple and effective, and provides preference basis to test leak of freeze-dry powder injector container closure system. |
| Key words: vacuum degree freeze-dry powder injector leak |
