摘要
目的研究冻干重组水蛭素Ⅲ的稳定性,为选择包装材料、确定贮藏条件和有效期提供依据。方法通过影响因素实验,加速实验和长期稳定性实验,对其外观性状、溶解性、干燥失重、活性等进行研究。结果该制剂的主要影响因素是湿度和温度,光照影响不大;加速试验条件下6个月时活力能保持80%左右,其他指标正常;长期稳定性试验条件下,放置12个月后,各项指标均符合质量标准。结论该制剂可在室温下稳定保存12个月。
Purpose To study on stability of recombinant hirudin Ⅲ for injection, and to give evidence on rational adoption of packaging material, storage condition and period of validity. Methods Stability of hirudin was based on influencing factor experiment, accelerating experiment and long-term experiment. The appearance, and solubility were observed, and bioactivity and loss on drying were determined. Results Major influencing factors were humidity and temperature while lighting affected slightly, samples under accelerating experiment for 6 months maintained 80 % bioactivity, meanwhile other indexes remained stable, and samples under . long-term experiment for 12 months possessed index accorded with every quality standard. Conclusion Recombinant hirudin Ⅲ for injection can be stored for 12 months at room temperature.
出处
《中国生化药物杂志》
CAS
CSCD
2008年第5期334-336,共3页
Chinese Journal of Biochemical Pharmaceutics
关键词
重组水蛭素Ⅲ
稳定性
recombinant hirudin Ⅲ
stability
