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目的:建立以高效液相色谱法同时测定香丹注射液中丹参素钠和原儿茶醛含量的方法,并比较不同厂家生产的香丹注射液中丹参素钠和原儿茶醛含量的差异,以控制香丹注射液的质量。方法:色谱柱为AlltimaC18柱(150mm×4.6mm,5μm),流动相为甲醇-0.5%冰醋酸(90∶10),检测波长为280nm。结果:丹参素钠、原儿茶醛的进样量分别在0.26～1.58μg(r=0.9995)、0.12～0.73μg(r=0.9996)范围内与各自峰面积的积分值呈良好的线性关系;丹参素钠、原儿茶醛的平均回收率分别为99.8%、99.7%,RSD分别为0.4%(n=6)、0.4%(n=6)。共测定12家企业生产的16批香丹注射液,丹参素钠、原儿茶醛含量范围分别为1.02～2.08mg·mL-1、0.24～0.51mg·mL1。结论:该方法简便、准确、无干扰,可用于同时测定香丹注射液中丹参素钠和原儿茶醛的含量;不同厂家生产的香丹注射液之间存在显著质量差异,建议厂家重视原药材质量,改善制剂工艺,提高产品质量。
OBJECTIVE: To establish a method for the simultaneous determination of Danshensu sodium and protocatechuic aldehyde in Xiangdan injection by HPLC, and to compare the differences in the content of Danshensu sodium and protocatechuic aldehyde in Xiangdan injection produced by different manufacturers , To control the quality of Xiangdan injection. Methods: The column was Alltima C18 (150mm × 4.6mm, 5μm). The mobile phase consisted of methanol-0.5% glacial acetic acid (90:10) and the detection wavelength was 280nm. Results: The injection volumes of Danshensu sodium and protocatechuic aldehyde showed a good linear relationship with the integral values of their peak areas in the range of 0.26-1.58μg (r = 0.9995) and 0.12-0.73μg (r = 0.9996), respectively. The average recoveries of sodium danshensu and protocatechuic aldehyde were 99.8% and 99.7%, respectively, with RSDs of 0.4% (n = 6) and 0.4% (n = 6), respectively. A total of 16 batches of Xiangdan injection, danshensu sodium and protocatechuic aldehyde were determined in 12 enterprises, ranging from 1.02 to 2.08 mg · mL-1 and from 0.24 to 0.51 mg · mL -1, respectively. Conclusion: The method is simple, accurate, non-interfering and can be used to determine the content of Danshensu sodium and protocatechuic aldehyde in Xiangdan injection at the same time. There are significant differences in quality between Xiangdan injection produced by different manufacturers, Medicinal quality, improve preparation technology, improve product quality.