注射用曲札茋苷与常用输液配伍稳定性研究
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1.云南中医学院,云南昆明650500;2.昆明制药集团股份有限公司,云南昆明650100

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R285.6

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基金项目:云南省重大新产品开发计划资助项目(2013BC001)收稿日期:2014-11-10作者简介:唐嘉悦(1988-),女,内蒙赤峰人,在读硕士研究生,主要研究方向:原料药及制剂质量标准的研究。△通信作者:陈云建,E-mail:chyjkm@163.com


Quzhazhigan for Injection with Common Infusion Compatibility Test
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Affiliation:

1. Yunnan University of TCM, Kunming 650500, China;2. Kunming Pharmaceutical Corporation, Kunming 650100, China

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    摘要:

    目的观察注射用曲札茋苷与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液在4种条件下配伍的稳定性。方法将注射用曲札茋苷分别与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液配伍后,放置于室温、低温2~8℃避光、室温避光、室温强光照(4500lx±500lx)条件下。采用高效液相色谱法测定含量、降解产物,同时测定pH值、外观。结果注射用曲札茋苷与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液配伍后在低温2~8℃避光、室温避光条件下0~8h内其外观、pH值及含量、降解产物均无显著性改变。结论研究提示注射用曲札茋苷与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液配伍后在低温2~8℃避光、室温避光条件下较为稳定,实验结果可供临床配伍使用参考。

    Abstract:

    Objective To investigate the stability of compatible Quzhazhigan for injection with 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, under four conditions. Methods Quzhazhigan for injection was mixed with 5% and 10% glucose infusions, and 0.9% sodium chloride Injection at the room temperature, 2~8℃ in dark, room temperature in dark, room temperature in strong light conditions, within 8h after which the changes of appearance, pH value, the changes of degradation products and the changes of Quzhazhigan contents in them were determined by HPLC. Results There are no significant changes in appearance, pH value of the mixture solutions, degradation products and Quzhazhigan contents in them within 8h after they were prepared at the 2~8℃ in dark, room temperature in dark conditions. Conclusion The test that prompts Quzhazhigan for injection can be mixed with the 3 infusions for clinical use within 8h at the 2~8℃ in dark, room temperature in dark conditions. And its are available for clinical use compatibility reference.

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