仿制药注射用帕瑞昔布钠包材相容性研究

目的：考察仿制药注射用帕瑞昔布钠与其包材的相容性。方法通过脱片、迁移试验，影响因素下正置和倒置、加速试验，观察、测定并比较仿制药注射用帕瑞昔布钠各考察时间下性状，可见异物，不溶性微粒，杂质，含量的变化。结果脱片、迁移试验较考察初期均没有显著变化（P ﹥0.05），且各指标均在可接受的安全阈值；在影响因素各条件下，正置和倒置样品各项指标无明显差异（P ﹥0.05），在加速条件（1月、2月、3月和6月）下，包材相容性样品（倒置）和稳定性考察样品（正置）各项指标无显著差异（P ﹥0.05）。结论仿制药注射用帕瑞昔布钠与包材相容。

Study on the compatibility of generic drug - Parecoxib Sodium for Injection with its packing materials

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.