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高渗氯化钠右旋糖酐70注射液稳定性研究
引用本文:王波,赵莲,王字玲,王广义,赵敬湘,赵晓宇,张玉华,周虹. 高渗氯化钠右旋糖酐70注射液稳定性研究[J]. 中国药学杂志, 2007, 42(5): 368-370
作者姓名:王波  赵莲  王字玲  王广义  赵敬湘  赵晓宇  张玉华  周虹
作者单位:军事医学科学院野战输血研究所,北京,100850
基金项目:首都特色临床医学技术发展研究课题;军队指令性课题
摘    要: 目的研究高渗氯化钠右旋糖酐70注射液的稳定性。方法高效液相色谱法测定右旋糖酐70的相对分子质量与相对分子质量分布,分别用强光照射法、高温实验、低温实验、加速试验法和室温留样观察法对高渗氯化钠右旋糖酐70注射液进行稳定性试验。结果除高温、加速实验条件下右旋糖酐70含量略有下降外,均符合质量标准的规定。结论本品在避光、密闭的贮存条件下性质稳定,室温下贮存期可定为2年。

关 键 词:高渗氯化钠右旋糖酐  稳定性  高效液相色谱法
文章编号:1001-2494(2007)05-0368-03
收稿时间:2005-12-26;
修稿时间:2005-12-26

Study on Stability of Hypertonic Sodium Chloride Dextran 70 Injection
WANG Bo,ZHAO Lian,WANG Zi-ling,WANG Guang-yi,ZHAO Jing-xiang,ZHAO Xiao-yu,ZHANG Yu-hua,ZHOU Hong. Study on Stability of Hypertonic Sodium Chloride Dextran 70 Injection[J]. Chinese Pharmaceutical Journal, 2007, 42(5): 368-370
Authors:WANG Bo  ZHAO Lian  WANG Zi-ling  WANG Guang-yi  ZHAO Jing-xiang  ZHAO Xiao-yu  ZHANG Yu-hua  ZHOU Hong
Affiliation:Institute of Transfusion Medicine, Academy of Military Medical Science, Beijing 100850, China
Abstract:OBJECTIVE To study the stability of hypertonic sodium chloride dextran 70 injection. METHODS The contents of dextran70 were determined by HPLC. The stability of the samples were tested by strong-light, high-temperature,low-temperature exposure. accelerating experiment and room temperature storage. RESULTS After being exposured to high-temperature and accelerating condition, the content in HSD was lightly decreased,but on other experiments, it was rather stable. CONCLUSION This injection should be kept away from high light and may be stored for 2 years at room temperature.
Keywords:hypertonic sodium chloride dextran   stability    HPLC
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