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目的评价全氟丙烷人血白蛋白微球注射液在2～8℃保存的稳定性。方法将3批全氟丙烷人血白蛋白微球注射液放2～8℃保存,于不同时间取样,检测微球浓度、平均粒径、全氟丙烷气体含量、IgG各组分含量及其他各项主要指标。结果3批制品保存30个月,其微球浓度、平均粒径、直径小于10μm的微球百分数和全氟丙烷气体含量均无明显变化,IgG各组分含量及其他各项主要指标均达到《中国药典》三部(2005版)的要求。结论全氟丙烷人血白蛋白微球注射液在2～8℃保存30个月,稳定性良好。
Objective To evaluate the stability of perfluoropropane-loaded human albumin microsphere injection at 2-8 ℃. Methods Three batches of perfluoropropane human albumin microspheres injection were stored at 2 ~ 8 ℃ and samples were taken at different time to test the concentration of microspheres, the average particle size, the content of perfluoropropane gas, the content of each component of IgG and other The main indicators. Results Three batches of products were stored for 30 months. The microspheres concentration, average particle size, percentage of microspheres with diameter less than 10μm and the content of perfluoropropane gas did not change significantly. The contents of IgG and other major indexes reached “ Chinese Pharmacopoeia ”three (2005 version) requirements. Conclusion Perfluoropropane human albumin microsphere injection at 30 ℃ for 2 months is stable at 2 ~ 8 ℃.