用0.9%美国药典氯化钠注射液复溶后Kinevac的稳定性。
Kinevac stability after reconstitution with sodium chloride injection USP, 0.9%.
作者信息
Littleton Latisha T, Fileta Bader B, Massey Robert, Wood Timothy I
机构信息
Department of Pharmacy, Walter Reed Army Medical Center, Washington, DC, USA.
出版信息
J Nucl Med Technol. 2009 Mar;37(1):57-9. doi: 10.2967/jnmt.108.050732. Epub 2009 Feb 17.
UNLABELLED
Our objective was to compare the stability of Kinevac when reconstituted with sodium chloride injection, USP, 0.9%, versus the manufacturer's recommended sterile water for injection, USP, and to determine the effects on stability of deviating from the manufacturer's recommended methods of product preparation.
METHODS
Kinevac was reconstituted with either sterile water or 0.9% sodium chloride. Triplicate high-performance liquid chromatography was performed on each vial of reconstituted sample at time zero and at time zero plus 8 h. The concentration of each sample, as measured by the peak area, was recorded at each time point. The process was repeated over 4 consecutive days.
RESULTS
Kinevac reconstituted with sterile water resulted in the recovery of 89.73% of the time zero concentration after 8 h. Kinevac reconstituted with 0.9% sodium chloride resulted in chemical stability of the injection, with 80.05% recovery of the time zero value after 8 h.
CONCLUSION
Kinevac is more stable when reconstituted with sterile water than when reconstituted with 0.9% sodium chloride. Kinevac should be reconstituted with sterile water for injection as per the manufacturer's instructions.
未贴标签
我们的目的是比较用美国药典0.9%的氯化钠注射液复溶的Kinevac与制造商推荐的美国药典注射用水复溶时的稳定性，并确定偏离制造商推荐的产品制备方法对稳定性的影响。
方法
用无菌水或0.9%氯化钠复溶Kinevac。在复溶样品的每个小瓶中，在零时间点和零时间点加8小时时进行三次高效液相色谱分析。通过峰面积测量的每个样品的浓度在每个时间点记录。该过程连续重复4天。
结果
用无菌水复溶的Kinevac在8小时后恢复到零时间浓度的89.73%。用0.9%氯化钠复溶的Kinevac导致注射液化学稳定性良好，8小时后恢复到零时间值的80.05%。
结论
用无菌水复溶的Kinevac比用0.9%氯化钠复溶时更稳定。Kinevac应按照制造商的说明用注射用水复溶。
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