摘要
目的：比较4种厂家生产的维生素Kl注射液的药品质量，考察维生素K1注射液在医院常规条件下的稳定性。方法：AgilentXDB—C18色谱柱（4．6mm×250mm，5μm），以无水乙醇-石油醚（95：5）为流动相，流速1．0mL·min-1，检测波长为254nm。结果：四个厂家中有三个厂家生产的维生素Kl注射液的初始含量符合中国药典2010年版（二部）要求，含量范围在90％-110％，但各样品差异较大，且在12h内溶液中维生素K1含量明显下降。结论：该方法操作简便、结果可靠。建议药品生产过程中，严格控制维生素K1注射液的质量，在临床应用中，维生素K1注射液曝光放置3h以上应慎用。
Objective： To evaluate the quality of vitamin Kx injection from four manufacturers and study the stability of vitamin Kt injection under normal storage condition. Methods： An Agilent XDB-Ct8 column （4.6 mm× 250 ram, 5 μm） was used as separation column. Ethanol-petroleum ether （95 ： 5） was used as the mobile phase. Flow rate was 1.0 mL.min-1. The detection wave length was set at 254 nm. Results： The contents of vitamin KI from three manufacturers were in the range of 90% - 110%, which met the criteria of the 2010 edition of Chinese Pharmacopoeia （ II ）. But the individual variability was significant. The content of vitamin KI injection decreased obviously within 12 hours. Conclusion： The method was simple, accurate and reliable. The quality of vitamin K1 injection should be controlled in the process of production. Vitamin K~ injection should be used carefully in clinic if it is exposed under natural light over three hours.
出处
《中国药物应用与监测》
CAS
2012年第6期328-331,共4页
Chinese Journal of Drug Application and Monitoring
