药学研究2016，Vol.35Issue(4)：226-229,4.DOI:10.13506/j.cnki.jpr.2016.04.011
仿制药注射用帕瑞昔布钠包材相容性研究
Study on the compatibility of generic drug - Parecoxib Sodium for Injection with its packing materials
宋岩珺 1蒲旭峰 1朱鹏 2刘小双1
作者信息
- 1. 成都中医药大学，四川 成都 610072
- 2. 成都欣捷高新技术开发有限公司，四川 成都 610041
- 折叠
摘要
Abstract
Objective To inspect the compatibility of generic drug - Parecoxib Sodium for Injection with its packing materials. Methods By the tests of delamination and migration,positive position and inversions under the influencing factor accelerated tests to observe,determine and compare the changes of the character visible foreign matter insoluble particles, related substances,content for generic drug - Parecoxib Sodium for Injection in their study time. Results No significant differences were found in the delamination and migration tests compared with its early study(P ﹥ 0. 05),and each index was in the acceptable safety threshold;No significant differences were found in each index for samples in positive position and inversions under the influencing factor(P ﹥ 0. 05),in the accelerated treatment(1,2,3 and 6 months)each index for sam-ples of compatibility and stability were found no significant differences(P ﹥ 0. 05). Conclusion The packing materials had good compatibily with the generic drug - Parecoxib Sodium for Injection.关键词
注射用帕瑞昔布钠/中性硼硅玻璃管制注射剂瓶/氯化丁基橡胶塞/相容性Key words
Parecoxib Sodium for Injection/Injection vials made of neutral borosilicate glass tubing/Chlorobutyl rubber closures/Compatibility分类
医药卫生引用本文复制引用
宋岩珺,蒲旭峰,朱鹏,刘小双..仿制药注射用帕瑞昔布钠包材相容性研究[J].药学研究,2016,35(4):226-229,4.
