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目的:建立九味防瘟散中麝香酮含量测定方法,以麝香酮为指标研究该制剂的稳定性。方法:以HPLC-MS法测定麝香酮的含量;研究九味防瘟散在不同温度和包装条件下的稳定性。结果:麝香酮浓度在0.2~20 mg.L-1线性关系良好(r=0.999 9),精密度、回收率、稳定性、重复性均符合实验要求。稳定性方面,去外包装组麝香酮损失速率>包装组,35℃时麝香酮损失速率>4℃,密闭包装组麝香酮损失速率>密封包装组。结论:HPLC-MS法测定九味防瘟散中的麝香酮含量灵敏、快捷、简便、准确。九味防瘟散须在冷处密封条件下保存。
Objective: To establish a method for the determination of musk ketone in nine flavors anti-blasting powder. The musk ketone was used as an index to study the stability of the preparation. Methods: The content of muscone was determined by HPLC-MS method. The stability of the powder of Jiuwei was evaluated under different temperature and packaging conditions. Results: The linearity of musk ketone concentration was 0.2 ~ 20 mg.L-1 (r = 0.999 9). The precision, recovery, stability and repeatability all met the experimental requirements. In terms of stability, the loss rate of musk ketone in the unpackaged packaging group was higher than that in the packaging group at the rate of musk ketone loss of> 4 ℃ at 35 ℃ and the loss rate of musk ketone in the sealed packaging group. Conclusion: HPLC-MS method for the determination of musk ketone content in the nine anti-Wen San sensitive, fast, simple and accurate. Jiwei anti-plague powder to be sealed in the cold place to save.