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目的:建立蒿白伤湿气雾剂质量标准。方法:用HPLC法测定雪上一枝蒿甲素的含量,色谱柱为Welch Ultimate XBC18(250 mm×4.6 mm×5μm),流动相为磷酸盐缓冲液(磷酸氢二钠1.97 g,磷酸二氢钾0.22 g,加水溶解并稀释至1000 m L,用磷酸调节p H值至7.3)-甲醇(30∶70),柱温为30℃,流速为1.0 m L/min,检测波长为210 nm。结果:雪上一枝蒿甲素苷对照品在104.832~6552ng范围内线性关系良好(r=0.9999),平均回收率(n=6)为97.4%(RSD%为1.4%)。结论:本法简便、可靠、准确,可用于该制剂的质量控制。
Objective: To establish the quality standard of white dampness aerosol. Methods: The content of artemisinin in snow was determined by HPLC. The column was Welch Ultimate XBC18 (250 mm × 4.6 mm × 5 μm). The mobile phase consisted of phosphate buffer solution (1.97 g sodium phosphate dibasic, 0.22 g potassium dihydrogen phosphate g. Dissolve and dilute to 1000 mL with water. Adjust pH to 7.3 with phosphoric acid (30:70). The column temperature is 30 ° C and the flow rate is 1.0 mL / min. The detection wavelength is 210 nm. Results: The calibration curve was linear in the range of 104.832-6552 ng (r = 0.9999). The average recovery (n = 6) was 97.4% (RSD% 1.4%). Conclusion: This method is simple, reliable and accurate and can be used for the quality control of the preparation.