摘要
目的考察具有螯合结构特征的五水头孢唑林钠的稳定性。方法以无定型头孢唑林钠为对照,按中国药典2005版二部附录XIX C药物稳定性实验指导原则考察样品24个月的稳定性。结果实验中五水头孢唑林钠的澄清度、溶液颜色和pH基本无变化,单个杂质含量为为0.1%,总杂质含量为0.37%,含量为93.2%～94.7%。结论五水头孢唑林钠在长期稳定性实验中的指标显著优于无定型头孢唑啉钠。
Objective To evaluate the stability of cefazolin sodium pentahydrate for injection. Methods Cefazolin sodium for injection as a control, all stability parameters were evaluated according to the methods of the Chinese Pharmacopeia 2005 eddion appendices XIX C. Results At a period of 24 months, the items such as pH, constituted solution, and color were all meet the requirements. Especially the amounts of each peak area was not more than 0.1%, and the total area of the peaks except cefazolin sodium pentahydrate was not more than 0.37%, while the amounts of cefazolin sodium pentahydrate was between 93.2% to 94.7%. Conclusion The product specification of cefazolin sodium pentahydrate was significantly better than amorphous cefazolin sodium, and far higher than the Pharmacopoeia standards.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2009年第1期45-47,共3页
Chinese Journal of Antibiotics
