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。
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.
出处
《中国现代应用药学》
CAS
CSCD
2013年第7期770-772,共3页
Chinese Journal of Modern Applied Pharmacy
关键词
真空度
冻干粉针剂
密封
vacuum degree
freeze-dry powder injector
leak
