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目的:考察消瘀止痛气雾剂的稳定性,并预测其有效期。方法:以高效液相法测定消瘀止痛气雾剂中主成分羟基红花黄色素A的含量,采用初均速法对其有效期进行预测。结果:羟基红花黄色素A进样量在0.3969μg~2.1168μg范围内与峰面积线性关系良好(r=0.9996),平均回收率为98.43%,RSD为1.81%(n=6)。该气雾剂稳定性好,室温25℃下有效期为2年。结论:初匀速法预测消瘀止痛气雾剂有效期简便、迅速。
Objective: To investigate the stability of an acupuncture aerosol and predict its effective period. Methods: The content of hydroxysafflor yellow A, which is the main component in Xiaotan Zhitong aerosol, was determined by HPLC. The effective period was predicted by the method of initial average velocity. RESULTS: The calibration curve of hydroxysafflor yellow A in the range of 0.3969μg~2.1168μg had a good linear relationship with the peak area (r=0.9996). The average recovery was 98.43% and the RSD was 1.81% (n=6). The aerosol has good stability and is valid for 2 years at room temperature at 25°C. Conclusion: The initial uniform velocity method predicts the effective period of Xiaotan Analgesic aerosol is simple and rapid.